The Rutgers-Cleveland Clinic Consortium is part of the Armed Forces Institute of Regenerative Medicine (AFIRM), a multi-institutional, interdisciplinary network working to develop advanced treatment options for the nation's severely wounded servicemen and women.

Administrative oversight for all of the RCCC trials will be provided by the Clinical Trials Core which is housed at Case Western Reserve University. It is this group, headed by director Stanton Gerson, MD, that will implement and maintain the OnCore system as well as provide consortium-wide training on its use.

"Our primary need was to assist the Clinical Trials Core (a non participant in any of the trials) to manage the data and regulatory reporting from remote and multicenter sites. Secondarily, OnCore will help us track the regulatory approval and other review processes from all of the sites," said Jane Reese, Operations Director at University Hospitals Case Medical Center.

Through OnCore's web-based interface, each of the participating organizations will be entering data throughout the lifecycle of their clinical trials. They'll enter information related to their local regulatory and administrative processes prior to opening the trials at their institution; they'll enter clinical and safety data throughout the conduct of the trials; and they'll track follow-up milestones after the trials are completed. With this central database, the Clinical Trials Core will be able to monitor patient safety and track study progress across all the participating organizations.

In addition to its web-based platform, OnCore was desirable because of the control it provides.

"Two of the things we like best about OnCore are that it is configurable by us and the data is housed by us. This is in contrast to other affordable systems in which configuration and modifications are performed by the vendor," said Reese.

Led by principal investigator, Joachim Kohn, PhD of Rutgers, the State University of New Jersey, and co-principal investigator George F. Muschler, MD of Cleveland Clinic, the RCCC team is built around an outstanding group of experts, working at advanced performance sites with approximately 160 personnel including about 40 faculty members and more than 40 post-doctoral associates. Participating institutions include Carnegie Mellon, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, Thayer School of Engineering at Dartmouth, Massachusetts General Hospital, Massachusetts Institute of Technology, Mayo Clinic, Northwestern University, Stony Brook University, University of Cincinnati, University of Medicine & Dentistry of New Jersey, University of Virginia, and Vanderbilt University. For more information on the AFIRM RCCC, visit the website at www.afirmrccc.org.

The OnCore platform is the product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations. The nation's most widely adopted clinical research platform among academic research organizations and cancer centers, the OnCore platform is the result of nearly a decade of experience working closely with large research organizations, including many world-class NCI designated cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program.

OnCore-CRM offers a comprehensive set of modules for managing all aspects of clinical research:

• Protocol & Subject Life Cycle Management
• Subject Safety Management
• Protocol & Subject Calendar Management
• Study Financials Management
• Electronic Data Capture and Data Management
• Paperless Committee Management with ePRMSM
• Study Information Portal
• Custom Reporting Technology

In addition to the clinical research management system, two other systems complete the OnCore family of products. These are OnCore for Biospecimen Management (OnCore-BSM) and OnCore for Unified Registries Management (OnCore-URM).

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

"This was the best experience in bringing a database up so quickly and smoothly," wrote Tracy Lynn, from the UFSCC Clinical Trials Office who was on the implementation team for the project.

In PercipEnz's 10-year history, this project represented the second-fastest implementation among those involving data migration, which, in this case, required moving data out of a Velos eResearch database into the OnCore system.

Leading the project to implement the new system, Giselle Moore-Higgs, Assistant Director of Clinical Trials at UFSCC, arranged resources to make the transition a priority throughout the summer in order to meet their September deadline. The assembled team, headed by Joe Stokes, RN, manager of Bone Marrow Transplant at Shands, included Crissy Greene, Manager of Information Services, and Tracy Lynn, Manager of the CTO Regulatory Office.

"Definitely, the teamwork and focus on the Shands side was critical to the success of this project" said Gopi Potnuru, Director of Software Development at PercipEnz." It was a pleasure to work with Joe and his team."

"We were very fortunate to have three staff members who had the clinical, regulatory, and computer knowledge needed to make this happen. Their dedication to this huge project along with the professionalism and team effort from PercipEnz helped us meet our tight deadline," said Moore-Higgs.

Now that the Clinical Trials Office has rolled-out the system, the cancer center will begin reaching-out to other research departments doing oncology trials throughout the university.

"We hope that OnCore will help us to expand the clinical trials program by allowing us to collaborate across the UF campus," said Moore-Higgs.

Member and guest contributions are critical to the success of all Onsemble conferences. For this event, representatives from 16 cancer centers sat on the Program Committee, which began working in March to plan the agenda. At the conference, presentations were delivered by over 22 member and special-guest speakers. Slide presentations, videos and other materials from the conference are now available for download from the Onsemble.net website.

The theme of this conference was, "Improving Research Efficiencies through Collaboration." And, in alignment with this theme, some new faces were seen at this event. For the first time, representatives from the pharmaceutical industry were invited to join the conversation. In addition to the 24 research organizations and cancer centers represented at the two-and-a-half day event, attendees also included people from the National Cancer Institute (NCI), Merck, Eli Lilly, the Association of American Cancer Institutes, and PercipEnz.

For the fifth consecutive conference, a pre-conference workshop was held, on the first morning, for members of clinical trials office leadership teams. As in the past, this workshop focused on developing measurements, or "metrics," for the purpose of understanding and thereby improving clinical research operations. There was also a roundtable discussion to explore issues around patient accrual. Special guests Dan Davis, from Eli Lilly, and Linda Parreco, from NCI, brought their perspectives to the discussion. An article about this workshop appeared in the Summer 2009 edition of the Onsemble Notes newsletter.

There were two other workshops that morning. One was for the OnCore Developer & Adopter Network (ODEAN). In this workshop, attendees explored the OnCore Software Development Toolkit, custom reporting, and an integration case study. The third workshop, designed for people who are new to OnCore or are considering implementing new functionality, provided an introduction to the Onsemble community as well as demonstrations of specific OnCore functionality.

The afternoon of that first day was kicked-off by the keynote address by Dr. Eliav Barr, Vice President of Oncology Clinical at Merck Research Laboratories. According to Dr. Barr, Oncology drug development often has the longest timelines and lowest probability of success compared with other therapeutic areas. Dr. Barr discussed some of the new approaches to reduce inefficiencies that are being piloted.

Continuing the "efficiency through collaboration" theme throughout the afternoon were panel discussions on inter-institutional data sharing and on harmonizing clinical trial portfolios with patient populations.

On the morning of the second day, Srini Kalluri, PercipEnz president and CEO, took the opportunity to update the community on happenings at the company, trends in OnCore utilization throughout the community, and activity among the special interest groups and collaborative initiatives. Then, Tony O'Hare, PhD, Chief Scientific Officer at PercipEnz, provided an update on the evolution of OnCore, both the current version as well as the development plan for the next year. Then, he unveiled the newest product in the OnCore portfolio, the OnCore system for Unified Registries Management (OnCore-URM). Next month, this system will be made available to the five centers that have been participating in the collaborative initiative for this project.

Representatives from several cancer centers shared their success stories on Thursday afternoon. Topics included OnCore adoption strategies, auditing and monitoring of clinical trials, managing affiliates and multi-site trials, and cancer center organizational structure. A poster session on the organizational structure of seven participating cancer centers was held during an extended break midway through the afternoon. The afternoon was capped-off by an appearance by special guest, John Speakman, from NCI, who spoke at length with the group about the NCI's new Clinical Trials Reporting Program (CTRP).

The final morning of the conference was devoted to concurrent breakout sessions. With ample time for open discussion, these sessions focused on issues in specific operational areas: (1) Regulatory Management, (2) EDC & Data Management, and (3) Clinical Research Financials Management.

Onsemble conferences provide important networking and educational opportunities for those concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use OnCore® software to manage their clinical research operations, the community now boasts almost 800 members.

As the OnCore community has grown, so have the conferences. The first conference, held in February, 2006, was a two-day event focused largely on OnCore functionality. Since then, the conference has grown to almost three days to accommodate an expanded agenda.

Planning has already begun on the 2010 Spring Conference which will be co-hosted by the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill for the second time. The venue will be the same as in 2008, for the event, which will be held February 10^th through the 12^th at the Rizzo Center on the UNC campus.

MADISON, Wis. (June 20, 2009) — A power-packed roundtable discussion has been assembled to explore issues around patient accrual as part of a pre-conference workshop at the upcoming Onsemble 2009 Fall Conference. For the fifth consecutive conference, a workshop will be included that is specifically designed for clinical trials office leadership. As in the past, this workshop will also focus on developing measurements, or "metrics," for the purposes of understanding and improving clinical research operations.

A breadth of perspectives will be represented by two special guests who have been invited to give presentations and participate in the patient accrual roundtable.

Bringing the pharmaceutical industry perspective, Daniel Davis, oncology clinical operations team leader at Lilly, will explore, "Industry Clinical Research Sponsor Perspectives." In his presentation, he will discuss current pressures pharmaceutical companies are experiencing and how they are refining their research processes in order to get high-quality work done in a timely and cost efficient manner. His presentation will touch on such topics as: regulatory timelines, contracts and budgets, patient enrollment expectations, and data management. Davis brings 22 years experience, most of it spent in the oncology arena, in the pharmaceutical industry to the discussion.

Linda Parreco, RN, MS, from the Office of Partnerships and Dissemination Initiatives at the National Cancer Institute (NCI), will be addressing NCI initiatives to improve clinical trial accrual. Her group is working to identify ways to support recruitment through education, training, communication strategies, and tools. One of these initiatives is an online tool, in the early phase of development, that will support recruitment efforts for NCI clinical trials.

The first Onsemble workshop to focus on metrics was held in September, 2007. The decision to hold such a workshop emerged from the observations at member centers that it was difficult to quantify and communicate operational challenges related to protocol performance, protocol implementation, and research staffing. These workshops are now held at every Onsemble conference and a poster based on the work done in this group was presented at the ASCO meeting in May, 2009 by Kerry Bridges, MBA, RN,CCRC, of the Indiana University Simon Cancer Center and Henry Durivage, PharmD, of The Cancer Institute of New Jersey.

This spring, a collaborative initiative, headed by Bridges and Durivage was launched to build on these successes and provide a more formal framework to accomplish the work that is done in this area.

To date, significant progress has been made by the participating centers, particularly in three areas:

1. Observations regarding protocol performance. This has resulted in the establishment of methods to measure the impact of initiatives. For example, the effectiveness of protocol selection rules have been measured and proven to improve protocol performance.
2. Protocol implementation metrics. This has resulted in the establishment of protocol implementation benchmarks and score cards to allow centers to compare their performance against performance of all participating centers and to pinpoint areas for improvement.
3. Regulatory staff effort. This has resulted in the ability to estimate regulatory capacity with more precision than previously known. Data from 17 participating Cancer Centers resulted in actual (median) number of hours worked to open a protocol by sponsor type as well as regulatory staff capacity required per center.

Participation in the collaboration and workshops is open to all OnCore centers and other institutions. Centers interested in participating may contact Kerri Phillips at info@onsemble.net.

Onsemble conferences provide important networking and educational opportunities for people concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use the OnCore® platform to manage their clinical research operations, the Onsemble community now boasts 27 centers and a membership of almost 700.

At the upcoming workshop, some of the most recent outcomes of the collaboration will be presented in the form of aggregated measurements collected from participating cancer centers. The data will be reviewed and evaluated and the group will further explore any noteworthy results.

Onsemble® is a community of people who are committed to excellence in cancer clinical research operations. Onsemble members share best practices, contribute to an ever-growing knowledge base, and provide input into OnCore's evolution. PercipEnz Technologies, Inc. hosts Onsemble resources as a service to the community.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops enterprise-class clinical and translational research management software. The company's flagship product, the OnCore® informatics system, is the nation's most widely adopted clinical research platform among academic research organizations and cancer centers.

The OnCore platform is the result of nearly a decade of experience working closely with large research organizations, including many world-class NCI designated cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program. By actively engaging users throughout the development process, PercipEnz delivers solutions that address the underlying operational challenges facing organizations and their staff. The OnCore system is a proven, effective, and sustainable informatics infrastructure that supports streamlined clinical research operations. The platform is powerful and secure while providing the flexibility required by individual institutions to support their unique organizational structures and workflows.

"We began looking for a new clinical trials management system primarily because of our collaborative agreement with the Moffitt Cancer Center," said Giselle Moore-Higgs, Assistant Director of Clinical Trials at UFSCC. "We wanted a system that would allow us to do collaborative clinical research and share data with other organizations and OnCore allows us to do that."

The OnCore platform is the product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations. Using OnCore in conjunction with services available through the Crescendo Clinical & Translational Research Exchange (www.CrescendoEx.com), clinical research organizations are able to selectively share protocol, subject, and clinical data with their partners anywhere in the world. Crescendo services are seamlessly integrated with the OnCore platform.

Over the last decade, the people of PercipEnz have had the privilege of working in close collaboration with many world-class cancer research organizations. To date, there are 25 cancer research centers, 17 of which are National Cancer Institute (NCI) designated, that have adopted OnCore to manage their entire research portfolios. Through the Onsemble community (www.Onsemble.net), this group of institutions interact on many fronts, making significant contributions to the development of shared best practices and providing direction in the continuous evolution of OnCore.

"It's a true pleasure to welcome the Shands Cancer Center into the OnCore community" said Srini Kalluri, president and CEO of PercipEnz. "I am quite certain that Shands will not only benefit from the collective contributions of the existing Onsemble membership, but they will also become a terrific contributor to the improvement of the broader cancer research operational context."

The UFSCC has set an aggressive timeline to transition from their legacy system to OnCore. "We hope to migrate our data and go live with OnCore for our clinical data by September first," said Moore-Higgs.

In order to accomplish this, the cancer center clinical trials office will roll-out the system first. Once that group has fully rolled-out the system, the cancer center will begin reaching out to other research departments doing oncology trials throughout the university.

"We hope that OnCore will help us to expand the clinical trials program by allowing us to collaborate across the UF campus," said Moore-Higgs.

In order to meet the September deadline, the center has arranged resources to make the transition a priority throughout the summer. Work has already begun to clean up the legacy database in preparation for a smooth data migration.

The UFSCC will be implementing both the OnCore Clinical Research Management (OnCore-CRM) and the Biospecimen Management (OnCore-BSM) products.

OnCore-CRM offers a comprehensive set of modules for managing all aspects of clinical research:

• Protocol & Subject Life Cycle Management
• Subject Safety Management
• Protocol & Subject Calendar Management
• Study Financials Management
• Electronic Data Capture and Data Management
• Paperless Committee Management with ePRMS
• Study Information Portal
• Custom Reporting Technology

The fully integrated OnCore-BSM product supports all aspects of biospecimen and biorepository management:

• Inventory Management
• Annotation Management
• Requisition & Distribution Management
• Correlative Study Sample Management
• Flexible Reporting Capabilities

The clinical and translational research activity at UFSCC (www.ufscc.ufl.edu) occurs primarily on the University of Florida's Gainesville campus. The University of Florida is one of just three institutions in the country that have a one-campus Health Sciences Center consisting of colleges devoted to medicine, nursing, dentistry, veterinary medicine, pharmacy, and public health and health professions. This unique environment provides an ideal opportunity to bring diverse individuals together to conduct cancer research and develop future treatment and preventive options for cancer patients. In addition, the center has strong working relationships with many community physicians across the state of Florida and southeast Georgia.

The multidisciplinary teams at UFSCC include individuals from many disciplines — surgical oncology, medical oncology, radiation oncology, pathology, diagnostic and interventional radiology, nutrition, and social work, as well as members from specialty medicine and surgical disciplines. Each team provides treatment options based on traditional methods, as well as innovative research alternatives.

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

In celebration of the company's ninth anniversary, three employees were awarded the 2009 PercipEnz Award of Excellence. Recipients were James Wurdeman, Laura Craig, and Mark TenHoor. Awardees were recognized for their outstanding performance and collaborative excellence.

Gopi Potnuru was promoted to Director of Software Development.

Peter Rebholz was promoted to Senior Software Engineer.

With these additions, PercipEnz now has 33 employees, representing a 10% increase over a six-month period.

Brooks Boyd joined as Web Developer in January 2009. Brooks brings five years experience in web development, graphic design, and motion graphics to the table. He will help push PercipEnz's various websites to new heights, especially working on the new CrescendoEx.com portal to develop new and exciting means of integration between research organizations.

Anuradha Khemka joined as Software Engineer in January, 2009. A recent graduate in Computer Science from University of Florida, Anuradha is excited about joining a marvelous team of developers and looks forward to contributing to the success of PercipEnz.

Janani Sundarrajan joined as Software Engineer in February, 2009. Janani is returning to PercipEnz where she completed an internship last year. A recent graduate in Computer Science from North Carolina State University, Janani looks forward to actively contributing to the OnCore codebase and helping design and develop new systems.

The latest version of the OnCore(r) clinical research management system epitomizes the collaborative development process of software developer, PercipEnz Technologies, Inc. Released April 27th, OnCore 9.0 not only sports a sleek new user interface but also incorporates over 200 enhancement requests provided by 20 research organizations.

Madison, Wis. (PRWEB) April 27, 2009 -- The latest version of the OnCore(r) clinical research management system epitomizes the collaborative development process of software developer, PercipEnz Technologies, Inc. Released April 27, OnCore 9.0 not only sports a sleek new user interface but also incorporates over 200 enhancement requests provided by 20 research organizations.

"This version of OnCore brings together enhancements that have been under development for almost a year through multiple collaborative initiatives," said Tony O'Hare, PhD, chief scientific officer at PercipEnz.

OnCore product development is heavily guided by collaborative projects in which dedicated individuals from various OnCore centers devote their time and energy into planning, implementing and evaluating new functionality in the OnCore system. One such project comes out of the Compliance Collaborative Initiative, which resulted in the new Audit Console. The new functionality allows centers to conduct internal audits of clinical research records managed within, and outside of, OnCore.

In addition to collaborative initiatives, about one-third of the recent enhancements came from users via PercipEnz's "Top 5" program. In this program each research organization that uses OnCore is asked to submit their top enhancement requests. Then, PercipEnz commits to implementing as many of the requests as possible in the subsequent version of OnCore.

"The Top 5 program is a reflection of our commitment to ensure that individual OnCore centers' priorities are addressed along with the collective needs of the broader research community," said Srini Kalluri, president & CEO of PercipEnz.

Probably the most noticeable enhancement in version 9.0 is the new menu system. Users will benefit from easier navigation by the elimination of scrolling and a more consolidated menu structure with drop-down menus.

No functional area of the system was untouched by this development initiative. Everything from Protocol and Subject Life Cycle Management to Biospecimen Management has been enhanced in some way.

Key enhancements to Protocol and Subject Life Cycle Management functionality include improved tracking of staff activities, the addition of user-defined annotations, the ability to track additional Investigational New Drug (IND) and Investigational Device Exemptions (IDE) information, and new data export capabilities.

"Special mention must be made of all the centers who collaborated with us on this version," said O'Hare. "For example, it was collaborator input that helped us hone the Financials Management functionality to better support very large, multi-disciplinary research institutes."

The Financials Management functionality in OnCore underwent major transformation with Version 9.0, which now includes such functionality as the ability to manage multiple versions of charge masters and the ability to view and email billing slips for subject visits.

The OnCore system for biospecimen management (OnCore-BSM) was also greatly enhanced in the latest version. Enhancements include improved configurability of specimen collection schedules for correlative studies, new specimen annotation capabilities, and an extensible dashboard which provides a snapshot of repository activities.

Less noticeable to the everyday user, but increasingly important in today's research environment, is the fact that OnCore 9.0 represents a single clinical and translational research platform for all organizations whether they be a small, single-department cancer center or a very large multi disciplinary research organization. Because all 26 centers that use OnCore are working within the same clinical informatics platform, old barriers to inter-institutional data exchange are eliminated.

Version 9.0 corresponds closely with the launch, in February of this year, of the Crescendo Clinical & Translational Research Exchange. OnCore 9.0 is fully integrated with Crescendo services, which include:

1. Inter-Institutional Data Exchange--allowing seamless transfer of protocols and subject demographics between centers that use OnCore.
2. Metrics and benchmarks--aggregating anonymized data from OnCore centers and allowing individual centers to compare their performance to aggregated averages.
3. IIT Search--allowing people to locate investigator initiated trials conducted at participating OnCore centers.

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops enterprise-class clinical and translational research management software. The company's flagship product, the OnCore informatics system, is the nation's most widely adopted clinical research platform among academic research organizations and cancer centers.

The OnCore platform is the result of nearly a decade of experience working closely with large research organizations, including cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program. By actively engaging users throughout the development process, PercipEnz delivers solutions that address the underlying operational challenges facing organizations and their staff. The OnCore system is a proven, effective, and sustainable informatics infrastructure that supports streamlined clinical research operations. The platform is powerful and secure while providing the flexibility required by individual institutions to support their unique organizational structures and workflows.

With the signing of the contract for the OnCore Clinical Research Management system (OnCore CRM), the MBRCC has become the 24th cancer center to adopt the OnCore platform in support of its clinical research informatics needs. OnCore is the most widely adopted informatics platform among cancer centers nationwide and is used by one out of every four NCI-designated cancer centers.

The MBRCC is West Virginia's most comprehensive cancer treatment, research and education facility. The center offers a multidisciplinary team approach and state of the art technologies and treatments, as well as the latest clinical trials and a variety of education and prevention outreach programs.

The Cancer Center, operated by WVU Hospitals, houses the NCI's Mid-Atlantic Cancer Information Service, the Betty Puskar Breast Care Center and the Blood and Marrow Transplant / Hematologic Malignancy Program. For more information, visit the MBRCC website at: www.hsc.wvu.edu/mbrcc/

The OnCore system is the flagship product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations.

MADISON, Wis. (April 3, 2009) -- Cincinnati Children's Hospital Medical Center (CCHMC) went live March 25th with the implementation of OnCore in their Oncology department.

The project was kicked-off last fall when staff began to migrate data from their legacy system for Oncology to OnCore. "We had been using the same database for years," said Rebecca Turner, Oncology Clinical Research Manager for Hematology and Oncology at CCHMC. "Since our database was not as comprehensive as OnCore, we had a lot of work to do."

But, Turner expects that the extra work will pay off. "OnCore will hold vast amounts of information that we did not previously have available," she said. "It will be much easier to track the progress of a protocol and to make sure that the correct version numbers are used for all study-related documents. Those things are key to protecting our study subjects and providing them with the most accurate, up-to-date information available. We look forward to expanding into additional OnCore functionality in the near future"

In celebration, PercipEnz had a cake delivered. "We killed it! Only scraps are left! Yum!" wrote Rebecca Turner, Oncology Clinical Research Manager for Hematology and Oncology at CCHMC.

The hospital is taking a phased approach to implementation. "We went live with oncology data first so we could identify and eliminate glitches in our processes," said Turner. "Using 'lessons learned' should make the hematology implementation go more smoothly."

Since the oncology go live date, Turner and her staff have already added a variety of new studies to OnCore. So far, things are going well. "The final migration went very smoothly," says Turner. "Next stop . . . Hematology!"

"We chose OnCore based on a comprehensive range of criteria including ease-of-use, simple and fast study start-up, zero-footprint, browser-independent capabilities, and PercipEnz Technologies' dedication to customer support," said Sorena Nadaf, MS, MMI, Director of Translational Informatics and CIO at the UCSF HDFCCC. "As we evaluated systems, we were continuously impressed with the pace of OnCore's evolution as new features and functionality are added. We clearly identified PercipEnz Technologies' solid investment in product development and innovation to be centrally focused on the needs of cancer centers and the clinical research community."

Over one year ago, the HDFCCC, under the direction of Nadaf, initiated a wide-ranging assessment of the centers' clinical and translational research needs. The center has a heterogeneous and complex clinical research environment. It was clear that, in order to improve and expedite performance of the centers' infrastructure, it would be imperative to implement a comprehensive clinical trials management system that was capable of handling the life-cycle activities of any given trial from letter of intent to study close-out.

The OnCore system is the flagship product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations.

"Throughout the procurement process, we were impressed by the level of engagement by the people at the Helen Diller Family Comprehensive Cancer Center," says Srini Kalluri, president and CEO of PercipEnz. "The impressive breadth and depth of their questions illustrates the strength of their clinical research operations."

With the signing of the contract for the OnCore clinical research management system, the HFDCCC at UCSF has become the 23rd cancer center to adopt the OnCore platform in support of its clinical research informatics needs. OnCore is the most widely adopted informatics platform among cancer centers nationwide and is used by one out of every four NCI-designated cancer centers. The HFDCCC is implementing both the OnCore Clinical Research Management (OnCore-CRM) and the Biospecimen Management (OnCore-BSM) products.

OnCore-CRM offers a comprehensive set of modules for managing all aspects of clinical research:

• Protocol & Subject Life Cycle Management
• Subject Safety Management
• Protocol & Subject Calendar Management
• Study Financials Management
• Electronic Data Capture and Data Management
• Paperless Committee Management with ePRMS
• Study Information Portal
• Custom Reporting Technology

The fully integrated OnCore-BSM product supports all aspects of biospecimen and biorepository management:

• Inventory Management
• Annotation Management
• Requisition & Distribution Management
• Correlative Study Sample Management
• Flexible Reporting Capabilities

"In addition to all the technical capabilities that OnCore provides, our patients' safety and management in clinical trials will move to a new level here at UCSF," said Marcy Fraser, RN, MBA, Director of Operations, Investigational Therapeutics Initiative at the HDFCCC.

The HDFCCC won't be the only program benefitting from OnCore. The center has joined forces with the new Data Coordinating Center (DCC) in the UCSF School of Dentistry, directed by Dr. Stuart Gansky, associate professor. The DCC will coordinate six randomized clinical trials in three centers for research to reduce oral health disparities in children: Boston University, University of Colorado — Denver, and UCSF.

"I'm quite confident that the Helen Diller Family Comprehensive Cancer Center will maximize the benefits they receive from OnCore because they are methodically engaging representatives from across their institution in the implementation process. We have found this to be a key success factor for large and complex research organizations like UCSF," says Kalluri.

Nearly two years ago, the CFCCC, under the direction of Dr. Meyskens, initiated a wide-ranging assessment of the center's clinical and translational research needs. The initial evaluation clearly identified that, in order to improve and expedite performance of the center's clinical and translational research infrastructure, it was critical that they implement a comprehensive clinical trials management system.

Informatics Manager, Andrea Hwang, led this CFCCC initiative with a group of Cancer Center members and Research Administration managers. With an eye to wider institutional use, the review team was subsequently expanded to include multiple UC Irvine stakeholders.

"The Chao Family Comprehensive Cancer Center has been an active participant in caBIG deployment. One of our immediate goals is to acquire a caBIG-compatible clinical trial management system. Through the OnCore implementation, we wish to realize the potential benefit in increasing the research efficiency, translational efficiency, and operation efficiency from fostering the collaborative research within UC Irvine, as well as between our center and the wider caBIG community," says Hwang.

The OnCore system is the flagship product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations. The most widely adopted informatics platform among cancer centers nationwide, OnCore is used by one out of every four NCI-designated cancer centers to administer their portfolios of clinical trials.

Work to implement the system at CFCCC began immediately. Already, the CFCCC and PercipEnz are in the process of migrating existing data into OnCore and are on track to go live with the system in the second quarter of this year.

"The people at the Chao Family Comprehensive Cancer Center have invested a lot of thought and preparation into their implementation of OnCore," says Srini Kalluri, president and CEO of PercipEnz. "It's clear that they will realize significant benefits because they're taking advantage of not only the full functionality of the system but also the propensity of a centralized data repository to unify a large organization."

The center is already pursuing the goal of fully integrated clinical data management and study administration capability by integrating OnCore with the local hospital electronic medical records system. Other plans for the near future include making the Paperless Committee Management, Subject Safety Management, Study Information Portal, Protocol and Subject Life Cycle Management, and Custom Reporting modules of OnCore available by this Summer. Additional functional modules of OnCore will be rolled-out through the end of the year.

In the long term, Dr. Meyskens sees even more possibilities. Since OnCore can also be used for multi-disciplinary and non-cancer research, Dr. Meyskens looks forward to collaborating with other UC Irvine research centers and departments who may want to make OnCore their clinical trials management system.

"OnCore is highly functional and will allow the CFCCC to be competitive in clinical trials at the national and international level. Other clinical units are welcome to work with us in the implementation of their clinical research goals as well," says Dr. Meyskens.

The OnCore Clinical Research Management system (OnCore-CRM) offers a comprehensive set of modules for managing all aspects of clinical research:

• Protocol & Subject Life Cycle Management
• Subject Safety Management
• Protocol & Subject Calendar Management
• Study Financials Management
• Electronic Data Capture and Data Management
• Paperless Committee Management with ePRMS
• Study Information Portal
• Custom Reporting Technology

The OnCore Biospecimen Management system supports all aspects of biospecimen and biorepository management:

• Inventory Management
• Annotation Management
• Requisition & Distribution Management
• Correlative Study Sample Management
• Flexible Reporting Capabilities

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

Coinciding with the 9th anniversary celebration for the company, PercipEnz Technologies, Inc. announces the launch of Crescendo(tm), the company's suite of services for clinical and translation research data exchange. The website, located at www.CrescendoEx.com, provides descriptions of the available services and acts as an access point for some of these. Catering to the needs of the cancer centers and multi-disciplinary research organizations that use PercipEnz's OnCore^® software platform, the Crescendo exchange fosters collaboration among, and leverages the collective expertise of, these world-class institutions.

Madison, WI (PRWEB) February 24, 2009 -- Coinciding with the 9th anniversary celebration for the company, PercipEnz Technologies, Inc. announces the launch of Crescendo^™, the company's suite of services for clinical and translation research data exchange. The website, located at www.CrescendoEx.com, provides descriptions of the available services and acts as an access point for some of these.

Crescendo is a set of services designed to enhance and accelerate clinical and translational research. Catering to the needs of the cancer centers and multi-disciplinary research organizations that use PercipEnz's OnCore^® software platform, the Crescendo exchange fosters collaboration among, and leverages the collective expertise of, these world-class institutions.

Crescendo services fall into three major categories:

1. Support for Multi-Center Clinical Trials
2. Establishment of Metrics & Benchmarks for Clinical Research Operations
3. Creation & Utilization of Research Registries

Support for Multi-Center Clinical Trials

Services in this category provide the infrastructure to easily launch highly secure, often transitory, clinical and translational research information networks involving a wide range of stakeholders. These services facilitate purpose-driven, secure, collaborative data exchange among major research institutions. How and when these services are utilized is based on the needs of the parties involved within the research community.

"Our goal with these services was to give researchers the freedom to collaborate with each other on their own terms. Crescendo gives them the choice of what data they want to share, under what circumstances, and with whom," says Tony O'Hare, PhD, Chief Scientific Officer at PercipEnz.

Crescendo services for multi-center trials also leverage the fact that all of the participating centers utilize the same informatics platform.

"Because these organizations use the same platform, many of the challenges inherent to collaborative research are eliminated. For OnCore centers, issues related to staff training, agreement on data fields, and even, in many cases, standard operating procedures are minimal or non-existent," says Srini Kalluri, president & CEO of PercipEnz.

Establishment of Metrics and Benchmarks for Clinical Research Operations

Services in this area provide tools for the leadership teams in the clinical trials offices of research centers. With these tools, they can evaluate the work their teams do and make informed decisions about resource allocation.

"We believe in the dictum, 'what cannot be measured cannot be improved,'" says Kalluri. "Through this service, participating centers contribute anonymously to a database of key measurements that provide insight into how their center is operating. Soon, these centers will be able to compare their individual measurements against aggregated results of centers across the country."

"With the number of centers that are participating, the Crescendo user base is uniquely poised to contribute to the national context," says Kalluri. "Already, this group is demonstrating thought leadership in the field of clinical research operational excellence. Crescendo just provides a central repository for the evidence-based innovations that they contribute."

Creation & Utilization of Research Registries

Services in this area are based on purpose driven databases that contain data aggregated from participating OnCore centers as well as other public data sources.

At the request of the OnCore community, the first registry service available through Crescendo allows participating centers to quickly identify clinical trials being run by OnCore centers across the country. This allows researchers to target collaborative opportunities within this highly desirable group. Previously, in order to conduct such a search, an individual would have to parse through a much larger database manually searching for trials hosted by known OnCore centers, or go to the online searchable database belonging to each OnCore center, one-by-one.

"The people at OnCore centers regard their peers with very high regard. Through their interactions in the OnCore community, they've come to expect a certain level of operational excellence from each other. This, combined with their common informatics platform, makes collaborating with other OnCore centers a very desirable option," says Kalluri.

For information about the OnCore research informatics platform, contact PercipEnz Technologies at (608) 826-6000 or visit the company online at www.PercipEnz.com.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops enterprise-class clinical and translational research management software. The company's flagship product, the OnCore^® informatics system, is the nation's most widely adopted clinical research platform among academic research organizations and cancer centers.

The OnCore platform is the result of nearly a decade of experience working closely with large research organizations, including cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program. By actively engaging users throughout the development process, PercipEnz delivers solutions that address the underlying operational challenges facing organizations and their staff. The OnCore system is a proven, effective, and sustainable informatics infrastructure that supports streamlined clinical research operations. The platform is powerful and secure while providing the flexibility required by individual institutions to support their unique organizational structures and workflows.

MADISON, WI -- A proven and widely adopted research informatics platform, OnCore^®, achieved another milestone this fall with the implementation at a world-class multidisciplinary research organization. At the end of September, the University of Wisconsin Institute for Clinical and Translational Research (UWICTR) began using OnCore to handle their clinical research data collection and administration needs. OnCore is the flagship product of PercipEnz Technologies, Inc., a software development company specializing in clinical and translational research informatics for midsized to large organizations.

Long held as the most widely adopted informatics platform among cancer centers nationwide, the OnCore system now brings its balance of sophisticated functionality and powerful extensibility to the large, multi-disciplinary, multi-departmental, clinical and translational research enterprise.

"We began working closely with the University of Wisconsin almost two years ago as they were formulating their plan to assemble the new institute's informatics system," says Tony O'Hare, PhD, chief scientific officer at PercipEnz. "While we had several years of experience supporting the complex informatics needs of cancer centers, the scope of the UWICTR project was an excellent opportunity to demonstrate the power of OnCore beyond cancer research."

"One of the most significant challenges facing multidisciplinary institutes is bringing together people and departments that do not have a long history of working together or sharing informatics resources," says Srini Kalluri, PercipEnz president and CEO. "This is exactly the kind of environment where the OnCore platform can provide an enormous benefit."

"To multi-disciplinary organizations, possibly the most salient aspect of OnCore's evolution is that it provides a sense of autonomy to individual departments and groups within an institution. OnCore does this while maintaining overall control and oversight of data, regulatory activities, and financials at the institutional level," says O'Hare. In OnCore, members of individual departments get a customized view of the system. This reduces clutter and allows individual departments to set-up key features like department-specific budget items, data entry parameters, and selection lists. "This way they can use the specific concepts, vocabularies, and other elements that are most applicable for their area of research."

The OnCore clinical research management system (OnCore-CRM) offers a comprehensive set of modules for managing all aspects of clinical research: (1) Protocol & Subject Life Cycle Management, (2) Subject Safety Management, (3) Protocol & Subject Calendar Management, (4) Study Financials Management, (5) Electronic Data Capture and Data Management, (6) Paperless Committee Management with ePRMS, (7) Study Information Portal, and (8) Custom Reporting Technology.

"The UWICTR is taking a very well thought-out and comprehensive approach to their informatics plan," says Kalluri. "They have made careful choices in the systems they are implementing to ensure their systems will grow with their needs, reduce duplication of effort, and provide maximum benefit from the data they collect."

UWICTR is also completing plans to implement the OnCore Biospecimen Management System (OnCore-BSM) in support of their biobanking and correlative study needs. OnCore-BSM, which is fully integrated with the clinical research management system, supports all aspects of biospecimen and biorepository management from collection and annotation, through specimen processing, storage, distribution and quality assurance, to withdrawal and depletion.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops enterprise-class clinical and translational research management software. The company's flagship product, OnCore^® is the nation's most widely adopted clinical research platform among academic research organizations and cancer centers.

The OnCore platform is the result of nearly a decade of experience working closely with large research organizations including cancer centers and institutes funded by the National Institute of Health's Clinical and Translational Science Award (CTSA) program. By actively engaging users throughout the development process, PercipEnz delivers solutions that address the underlying operational challenges facing organizations and their staff. OnCore is a proven, effective, and sustainable informatics infrastructure that supports streamlined clinical research operations. The platform is powerful and secure while providing the flexibility required by individual institutions to support their unique organizational structures and workflows.

MADISON WI -- PercipEnz Technologies, Inc., a computer software company that develops and markets proprietary, enterprise-class clinical and translational management informatics systems, is pleased to announce the following changes and additions to its team. With the latest addition in October, PercipEnz now has 31 employees, representing a 41% increase over the last 18 months.

Roger Chylla, PhD joined as Vice President of Engineering in August 2008. In this position he oversees the Development and Quality Assurance & Compliance activities for the company. Roger brings with him over a decade's worth of experience in the medical software sector including radiation therapy planning and medical imaging. Roger has broad experience in software development as a software engineer, engineering manager, executive, and cofounder of a medical imaging startup.

Debra Voss joined as Business Development Manager in November, 2007. Debra brings with her over 17 years experience in the healthcare industry. For the past six years, she has been involved in business development and most recently worked for a Madison-area hospital marketing technologies company. Additionally, she has experience managing grant-funded projects and working with national healthcare collaborative efforts.

Chad Adams joined PercipEnz as the Quality Assurance & Compliance Services Manager in May, 2008. Chad bring with him over 10 years of research experience in the healthcare industry and has spent most of that time working with infectious and chronic disease research. Chad leads an expanded quality assurance effort at PercipEnz Technologies and ensures that each PercipEnz product has the functionality and tools needed for customers to utilize in the efforts to be compliant to federal regulatory requirements related to clinical research.

Kung Chao joined as SQL Programmer in May, 2008. Kung brings him with over five years of experience in the tourism industry where he specialized in database development along with a year in the healthcare industry as a database specialist.

Mark TenHoor joined as Trainee Systems Administrator in June, 2008. Mark has always enjoyed working in computer networking and will graduate from Herzing College in December where his coursework has focused on security technology.

Colleen Krattiger, PMP joined as Implementation Coordinator in October, 2008. Prior to joining PercipEnz, Colleen acquired over 15 years of customer-focused experience in the software development, manufacturing, construction, and service fields. Her prior experiences include working for a medical device provider and implementing new systems.

Dean Ballweg has joined the newly formed Quality Assurance team as a Senior Software Quality Assurance Engineer. Bringing 10 years of experience in software testing and validation both at PercipEnz and previous employers, Mr. Ballweg looks forward to playing a key role in expanding the Quality Control efforts for the multiple products offered by PercipEnz Technologies.

MADISON WI -- Five cancer centers and two individuals were recognized for their outstanding contributions to the cancer research community during the Onsemble 2008 Fall Conference in August.

The annual Onsemble Collaborative Excellence award recognizes a centers' commitment of time and resources to a major collaborative initiative that benefits the broader cancer center community.

For the first time, individuals were recognized by the community with the Concertmaster Award which honors an individual's "sustained commitment to the pursuit of community goals and the dedicated leadership to keep us all hitting the right notes." Awardees of the Onsemble 2008 Concertmaster Award were Kerry Bridges, MBA, BSN, CCRC, Administrator of the Clinical Research Office at the Univeristy of Indiana Simon Cancer Center and Henry Durivage, PharmD, Director of Human Research Services at The Cancer Institute of New Jersey.

This year's collaborative excellence awardees were founding members of the OnCore / PDQ^® Interface Collaborative Initiative, a project that has resulted in seamless data exchange between cancer centers that use the OnCore^® clinical research administration software and the National Cancer Institute's Physicians Data Query (NCI('s PDQ) database. Key participants from these centers also received framed certificates recognizing their roles as "First Chairs," within the community.

Awardees of the Onsemble 2008 Collaborative Excellence Award were the Barbara Ann Karmanos Cancer Institute, The Cancer Institute of New Jersey, the Case Comprehensive Cancer Center, the UNC Lineberger Comprehensive Cancer Center, and the Vanderbilt - Ingram Cancer Center.

Srini Kalluri, President & CEO of PercipEnz Technologies along with the company's chief scientific officer, Tony O'Hare, PhD handed out the awards on the opening day of the Onsemble conference.

For more information about, or to download materials from, the Fall Conference, please visit the Onsemble 2008 Fall Conference page.

"Having recently achieved Bronze level compatibility certification, we're looking forward to the Silver level certification process becoming available," says Srini Kalluri, president and CEO of PercipEnz. "For a system as comprehensive as Oncore, a modular approach will make certification more manageable for reviewers."

caBIG^™ is an NCI-sponsored network of biomedical informaticists, researchers, vendors, and others who are creating interoperable infrastructure, tools, and data sets. The objective of caBIG^™ is to provide a framework to collect, manage, access and use data from diverse data resources within and across organizations. The ultimate goal of caBIG^™ is to create greater transparency and efficiency for cancer clinical and translational research.

Although Bronze is the only certification currently available for software developed outside of the caBIG^™ program, caBIG^™ intends to release the Silver Compatibility Certification process in the very near future. Silver level compatibility refers to a rigorous set of requirements that are designed to ensure that research institutions can more easily make their data accessible and usable by external partners.

All Oncore modules are built upon a process-centric, industrial-strength platform that provides a unified foundation with: data level security and access control; data integration; data distribution control; and a consistent navigational framework. With the new approach, the system will now be available as discrete modules, which all operate seamlessly within this common platform.

The modules for Clinical Research Management include:

1. Protocol & Subject Lifecycle Management
2. Subject Safety Management
3. Protocol & Subject Calendar Management
4. Study Financials Management
5. Electronic Data Capture (EDC) and Clinical Data Management (CDM)
6. Study Information Portal (SIP) and NCI PDQ^® Integration
7. Electronic Protocol Review and Monitoring System (ePRMS)
8. Ad hoc Reporting Technology

For Biospecimen Management, the modules include:

1. Inventory Management
2. Annotation Management
3. Requisition & Distribution Management
4. Correlative Study Sample Management
5. Ad hoc Reporting Technology

Each module represents a coherent group of distinct functions for which a concise set of objects, relevant common data elements, and application programming interfaces (APIs) can be defined.

"In addition to making the review of the first module go smoothly, we believe that this approach should expedite the review of subsequent modules of Oncore," says Dr. Tony O'Hare, chief scientific officer at PercipEnz.

PercipEnz has been an active participant in caBIG^™ since its inception, participating in such activities as special interest groups and conferences. Additionally, as part of its commitment to working with caBIG^™, PercipEnz independently hosts a collaborative initiative for cancer centers that use Oncore who are participating in the "Getting Connected with caBIG^™" program. This initiative allows the participating centers to leverage their collective expertise and common informatics infrastructure to achieve the goals outlined by caBIG^™. Bi-weekly teleconferences provide a forum for plan development, identification of opportunities to integrate with caBIG^™ technologies, and discussion of issues related to the centers' progress.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops and markets, enterprise-class clinical and translational research management systems for academic research organizations. By adopting a highly collaborative product development process, PercipEnz gathers, distills and fine-tunes the best ideas from world-class research institutions to deliver solutions addressing key operational challenges.

The company is host to Onsemble^®, a community comprised of research staff from centers around the country. Semi-annual Onsemble conferences provide important networking and educational opportunities for people concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use Oncore software to manage their clinical research operations, the community now boasts more than 500 members.

For more information, see the Compatibility & Certification page at the caBIG^™ website: https://cabig.nci.nih.gov/guidelines_documentation.

PercipEnz Technologies, Inc., a computer software company that develops and markets proprietary clinical and translational research management software, is pleased to announce the following promotions and awards.

In celebration of the company's eighth anniversary, two employees were awarded the 2008 PercipEnz Award of Excellence. Recipients were Peter Rebholz, and Jason Adams. Awardees were recognized for their outstanding performance and collaborative excellence.

Mark Gibson was promoted to Senior Software Engineer.

James Wurdeman was promoted to Senior Product & Training Specialist.

Jason Jaszewski was promoted to Senior Systems Administrator.

Kerri Phillips was promoted to Manager of Customer Experience Services.

Madison, WI - PercipEnz Technologies, Inc., makers of the most widely adopted clinical trials management software system among cancer clinical research centers, has received notice that their flagship product, Oncore, has been awarded the coveted caBIG™ Bronze Compatibility Certification.

The certification is based on compliance with guidelines set by the National Cancer Institute's Cancer Biomedical Informatics Grid (NCI's caBIG™) program. caBIG™ is an NCI sponsored, voluntary network of biomedical informaticists who are working to create interoperable software and data sets. The objective of caBIG™ is to provide a framework to both access and use data from remote data resources with the ultimate goal of creating greater transparency and efficiency for cancer clinical research operations.

"Oncore's certification as caBIG™ compatible is good news for the 20 cancer centers that use the system," says Srini Kalluri, President and CEO of PercipEnz. "It will also be of great interest to others in the research community because Oncore can play a key role in the adoption and adaptation of caBIG™ standards and technology."

Currently, Bronze is the only certification available for software developed outside of the caBIG™ program. "Of course we will be among the first to pursue Silver-level compatibility as soon as the certification process becomes available," says Kalluri.

Achieving this certification reflects that Oncore complies with the caBIG™ guidelines in each of four areas: (1) Programmatic access to data; (2) Use of controlled vocabularies; (3) Proper use and accessibility of data elements and metadata; and (4) The availability of a diagrammatic representation of the information model used.

PercipEnz has been an active participant in caBIG™ since its inception, participating in such things as special interest groups and conferences. Additionally, as part of its commitment to working with caBIG™, PercipEnz independently hosts a collaborative initiative for cancer centers that use Oncore who are participating in the "Getting Connected with caBIG™" program. This initiative allows the participating centers to leverage their collective expertise and common informatics infrastructure to achieve the goals outlined by caBIG™. Bi-weekly teleconferences provide a forum for plan development, identification of opportunities to integrate with caBIG™ technologies, and discussion of issues related to the center's progress.

"We're committed to providing research institutions unfettered access to secure electronic data exchange with each other, NCI, and their local environments," says Dr. Tony O'Hare, chief scientific officer at PercipEnz. "We believe that caBIG™ and the caDSR repository have a critical role to play in this."

caDSR is a repository of harmonized data elements and electronic case report forms that was created by caBIG™.

"We took a big step toward making caBIG™ semantic interoperability easy for our users by interfacing with caDSR in version 8.0," says O'Hare.

The interface allows Oncore users to seamlessly import and begin using Common Data Elements (CDEs), controlled vocabularies, entire electronic case report forms, and other objects maintained in caDSR. Adds O'Hare, "And, they can do all of this from within one screen within the Oncore system."

The interface allows Oncore users to seamlessly import and begin using Common Data Elements (CDEs), controlled vocabularies, entire electronic case report forms, and other objects maintained in caDSR. Adds O'Hare, "And, they can do all of this from within one screen within the Oncore system."

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops and markets, enterprise-class clinical and translational research management systems for academic research organizations. By adopting a highly collaborative product development process, PercipEnz gathers, distills and fine-tunes the best ideas from world-class research institutions to deliver solutions addressing key operational challenges.

The company is host to Onsemble^®, a community comprised of research staff from centers around the country. Semi-annual Onsemble conferences provide important networking and educational opportunities for people concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use Oncore software to manage their clinical research operations, the community now boasts more than 500 members.

For more information, see the Bronze Compatibility Certification page at the caBIG website.

PercipEnz Technologies, Inc., a computer software company that develops and markets proprietary, enterprise-class clinical and translational management informatics systems, is pleased to announce the addition of four team members.

Cindy Tracy joined as Director of Finance & HR in August, 2007. Ms. Tracy served as a Director of Celeritas Capital Partners and as a Manager/Shareholder of ZW Capital Partners, serving two local private equity firms for the past eight years.

Ryan Trier joined as Software Engineer in November, 2007. For the last nine years, Mr. Trier has been a Sun Certified Java Instructor. Prior to that, he worked in software development, project management, and training.

Kerry Hanko joined as Implementation Coordinator in December, 2007. Ms. Hanko brings with her over 20 years of management experience in multiple service industries. Specializing in building relationships through quality customer service and focused attention to detail, Ms. Hanko recently earned a Master's of Science degree in Management.

Jill McKinley joined as Product & Training Specialist in January, 2008. Ms. McKinley has13 years experience in the software industry where she specialized in support, training and server administration.

October 24, 2007

Volunteering their time and energy, several people from the community have stepped forward to provide leadership in planning the 2008 Spring Conference. In addition to being the first Onsemble gathering to be co-hosted by a member center, this conference will be the first with a formal program committee to help guide the content of the two-and-a-half day event. UNC - Lineberger Comprehensive Cancer Center will co-host the event in February in Chapel Hill, NC.

The conferences have continued to grow and evolve since the first gathering in 2006. To continue to provide the best possible value for attendees, it's important that the agenda reflect the needs and interests of the community. One very concrete way to accomplish this goal is to directly involve members.

The goals of this committee are to guide selection of discussion and presentation topics, identify quality presenters, and extend invitations to those individuals.

A record attendence of 131 including representatives from 22 world-class cancer centers converged on Madison in September for the Onsemble 2007 Fall Conference

Onsemble conferences provide important networking and educational opportunities for those concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use Oncore^® software to manage their clinical research operations, the community now boasts more than 415 members.

As the Onsemble community has grown, so have the conferences. The first conference, held in February 2006, was a two-day event focused largely on Oncore functionality. Since then, the conference has grown to three days to accommodate an expanded agenda.

On Wednesday morning, a special preconference workshop for clinical trials office directors and managers preceded the general session. At the request of past conference attendees, this session was added to provide clinical trials office leadership an opportunity to network and discuss issues with their peers. Attendees at the workshop worked to define metrics that can be used to measure the efficiency and performance of cancer clinical research operations.

Several distinguished guests spoke at the opening of the general session Wednesday afternoon. Topics included important national trends in cancer clinical operations, a panel discussion on clinical research compliance, updates on National Cancer Institute (NCI) and National Institute of Health (NIH) policies and projects, and ways to improve operational efficiency.

Thursday morning was devoted to breakout sessions. With ample time for open discussion, these sessions focused on issues in specific operational areas: (1) Regulatory Management, (2) Financials Management, and (3) Data Management. A hands-on workshop also took place that morning. Representatives from various cancer centers gave presentations and led discussions about their successful strategies and persistent challenges in these areas.

The remainder of the conference covered specific topics related to clinical research operations. As is typical, the membership played an indispensible role by preparing the majority of the content for these sessions. There were 23 representatives from various cancer centers who gave presentations and led discussions on topics ranging from electronic training tools to managing translational research resources for universities.

This is the second time Onsemble has met in Madison. In July of 2006, the Fluno Center, located on the University of Wisconsin's campus, accommodated the event which had 100 attendees. The people at PercipEnz Technologies are proud of their hometown, so they enjoy inviting the Onsemble membership to Madison for one conference every year. Other Onsemble conferences have taken place in Clearwater, Florida and Lansdowne, Virginia.

Planning has already begun on the 2008 Spring Conference which will be held at the Rizzo Center in Chapel Hill, NC on February 20th through 22nd.

Access Conference Materials on Onsemble.net.

Clinical research received a boost on Friday as a syndicate of investors came together to put money into a Madison area software company. PercipEnz Technologies, Inc. makes software that helps research centers manage all aspects of their clinical research operations -- from regulatory compliance to financials management to clinical data management. The organizations making the investment included NEW Capital Fund L.P., Wisconsin Investment Partners and Silicon Pastures.

PercipEnz is a computer software company that develops and markets specialized, enterprise-class clinical research and biospecimen management systems. The PercipEnz flagship product, the Oncore^® software platform, is intended to help research institutions increase their operational efficiency.

Government regulations can impose a significant compliance burden on scientific researchers. Although government regulations are meant to increase the integrity of scientific research data and thus increase the value of the results, compliance is not trivial, and there has been an increasing need for products that can reduce administrative headaches.

The Oncore platform helps researchers:

• administer their portfolio of clinical trials
• comply with government regulations
• streamline research operations and
• reduce duplication of effort with laboratory and hospital information system integration

"We have always taken a collaborative approach to satisfying the needs of research centers by actively involving them in the product development process," says Dr. Tony O'Hare, chief scientific officer at PercipEnz. "That's our 'innovating through collaboration' philosophy." Through monthly teleconferences, quarterly newsletters, collaborative development initiatives, a community website, and semi-annual conferences, Oncore users receive the benefits of networking and training while they provide input into Oncore's evolution.

The Oncore community, known as "Onsemble" convenes for their next face-to-face gathering, the Onsemble 2007 Fall Conference, on September 19-21 at Madison's Fluno Center.

Over 20 research organizations have adopted Oncore to manage their entire portfolio of clinical trials.

Expressing his appreciation for this new investment, Srini Kalluri, PercipEnz president and chief executive officer says, "As much as we believe in what we do, it is nice to receive this endorsement from the investment community. The funds we receive will allow us to fill key positions throughout the company in support of our expanded product offering and growing customer base. In the next few months, we expect to grow our organization by 50%, increasing our team to 33 employees."

NEW Capital Fund, LP, a venture capital firm headquartered in Appleton, led the investment group. Charlie Goff, the Fund's General Partner, said they were attracted to PercipEnz because of their significant market share in cancer clinical trial installations. Goff added, "What bodes well for PercipEnz's future is their potential for significant growth in the non-cancer clinical trial ERP arena."

NEW Capital Management, Inc. was joined in this investment by members of Wisconsin Investment Partners and Silicon Pastures.

"The company's growth is based on building quality relationships. This is evident from the number of highly satisfied customers, focused staff, and the collaberation with industry professionals and the investment community," says Robert Wood of Wisconsin Investment Partners.

"The company has achieved significant market traction. We were excited to see just how well their customers are responding to the Oncore product," said Teresa Esser, managing director of Silicon Pastures LLC.

July 12, 2007

MADISON, WI This fourth face-to-face gathering will provide content specifically addressing requests of the Onsemble membership. New this conference will be a special pre-conference workshop on Wednesday morning for clinical trials office administrators and managers. As was done at the spring conference, an entire morning will be set aside for concurrent breakout sessions focusing on specific job roles. Thursday and Friday will be spent on Oncore related topics such as discussions on how to get the most from Oncore and a look at evolving Oncore functionality.

View the Agenda
Register Now

June 2, 2007

MADISON, WI The newest version of Oncore released on July 2^nd, represents the institutional priorities of 20 cancer centers, and includes three, new modules.

Since 2001, through active collaboration with renowned cancer centers, Oncore has kept pace with evolving regulatory priorities and the collective requirements of these centers. By addressing this Unity in Diversity, Oncore has become the most comprehensive clinical research and biorepository management system that is available in the marketplace today.

As great as this might sound, institutions still have individual priorities which may or may not coincide with the collective priorities. To address this aspect of Diversity in Unity, earlier this year, each of the 20 Oncore centers was requested to present up to five enhancement suggestions, known as their "Top 5." Each of these requests were elaborated, evaluated, and prioritized in collaboration with the respective cancer centers.

The result is that 64 of the 109 enhancements that were incorporated in Oncore 7.0 came from the "Top 5" lists of the Oncore centers.

With the release of version 7.0, the Oncore platform has increased the ability for institutions to streamline their operations, to improve inter-departmental and inter-institutional communication and collaboration, and to decrease demands on staff time and resources.

Key enhancements of Oncore 7.0:

• A fully integrated custom reporting environment that utilizes the Oncore security framework.
• A new screening database that allows better tracking and assists in enhancing accruals.
• A new flow chart representation of available trials for the benefit of referring physicians.
• Multiple versions of protocol calendars to support protocol amendments.
• Electronic signatures in the ePRMS module to eliminate signature pages.

Integrated Custom Reporting through JasperReports

A special interface was developed for uploading custom report definition files. These custom reports can be created using a report writing application such as iReport. Additionally, the new interface can be used to export report definitions from Oncore which can then be shared with other cancer centers that use the platform.

Screening Database

A new screening database module was developed to provide cancer centers with a simple mechanism to evaluate their screening efforts. Using this module, the centers track information about the screening process which allows them to gauge the effectiveness of various referral channels and track staff time spent on screening.

Flow Charts

To assist cancer centers with their accrual goals, a new flow chart representation of available trials was developed. Inspired by the graphical representation used by the Vanderbilt Ingram Cancer Center, these flow charts are generated automatically within Oncore based on a simple hierarchy that is set up ahead of time. The flow charts are accessible via the Study Information Portal in Oncore for display on a cancer center's public website. Designed primarily to assist referring physicians, these flow charts may also aid potential subjects searching for available trials. (For more information, refer to "Finding Ways to Augment Accrual," an article in the Winter 2006 Onsemble Notes newsletter.)

Version Control of Specifications/Calendars

An important enhancement to the flexibility of protocol specifications comes with the new ability within Oncore to allow multiple versions of protocol calendars. This new feature handles changes due to protocol amendments that may or may not affect subjects who are already on treatment. Treating staff now have the flexibility to choose between multiple calendar versions for subjects based on what is appropriate given various factors. The feature also provides flexibility for any time lag between the actual subject visit and the time that data is being entered in the system.

Electronic Signatures

The new electronic signature feature in the ePRMS module eliminates the need for scientific review committee staff to obtain signatures on paper signoff sheets. Centers can elect to require all signatures to be electronic or to use a hybrid system with some signatures accepted in paper form. The new feature incorporates automatic email notifications and reminders for people who must sign new protocol submissions. For security, Oncore can manage user authentication internally or may be integrated with a cancer center's single sign-on technology utilizing a local, centralized authentication service.

Download in PDF

May 24, 2007

MADISON, WI Over the last 18 months, Madison company, PercipEnz Technologies, Inc. has experienced rapid growth. During this time, the number of people employed at PercipEnz has increased 60%, a hiring trend marked by the addition of the company's 22nd employee at the end of April.

To accommodate the growth, the company has moved to a new space with 6883 square feet, almost twice as much space as they have previously occupied. Company president and CEO, Srini Kalluri, is confident that, with adjoining space available for expansion, the company's new home will serve it well for several years to come.

"Because it is a new building, we were fortunate to be able to provide input as the construction was being completed. We designed the floorplan to accommodate our business structure and workflow. The entire space is customized to our needs and there is room for us to expand as we grow," says Kalluri.

The new space, which is leased from T. Wall Properties, LLC, is close to the company's previous office space on Madison's west side, so the transition has been smooth. Construction on the building, located at 708 Heartland Trail, was completed earlier this spring.

PercipEnz customers are accustomed to a high level of customer service and accessibility. As more customers have come on board, PercipEnz leaders have focused as much on increasing the number of customer support personnel as on adding people to the product development team. With the addition of two new product lines last year, Kalluri expects that the rate of rapid growth will continue into 2008.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops and markets proprietary, enterprise-class clinical and translational research management systems for academic research organizations. By adopting a highly collaborative product development process, PercipEnz gathers, distills and fine-tunes the best ideas from world-class research institutions to deliver solutions addressing key operational challenges.

MADISON, WI -- PercipEnz Technologies, Inc., a computer software company that develops and markets proprietary clinical and translational research management software, is pleased to announce the recipients of its annual employee awards.

In celebration of the company's seventh anniversary, four employees were awarded the 2007 PercipEnz Award of Excellence. Recipients were Laura Craig, Jason Jaszewski, Francis Kwok and James Wurdeman. This year's awardees were nominated by fellow employees in recognition of their outstanding performance and collaborative excellence.]]> urn:uuid:ef20370a-d958-0dfa-eeaa-ae4bac370a1c 2009-02-27T10:26:14-06:00 2007-05-01T00:00:00-05:00

May 1, 2007

CHICAGO, IL -- The Oncore People will be at Booth #18066 in the exhibition hall at the ASCO 2007 Annual Meeting. Renown research centers rely on Oncore.

]]>

SEATTLE, WA -- The Oncore People will be at Booth #300 in the exhibition hall at the ACRP 2007 Global Conference. Visit us and "Get the Scoop!" Oncore^® is now available for ALL areas of clinical research. With years of proven success supporting clinical research operations at world-class cancer centers, Oncore can now be used to manage multi-disciplinary clinical research operations. Renown research centers rely on Oncore.

MADISON, WI -- The third edition of Onsemble notes, the newsletter of the Oncore community, was published on April 11. A lot of great ideas came out of the 2007 Spring Conference. This issue brings home some of the key discussions for those of us who could not be there in person.

This quarterly newsletter is an important vehicle for providing members with updates on other Oncore centers and various collaborative initiatives. Included in this edition are articles on: Entering the Golden Age of Cancer Informatics; caBIG; CDISC; Cancer Centers' Role in CTSA; The Importance of Balanced Score Card Metrics for Clinical Centers; and the Onsemble 2007 Collaborative Excellence Awards.

The Onsemble notes newsletter is provided by PercipEnz Technologies, Inc. as a service to the Oncore community. Submissions, corrections, and comments are always welcome. Subscriptions may be requested.

Download PDF Version Now.

MADISON, WI -- For people concerned with excellence in cancer clinical research operations, the third face-to-face gathering of Onsemble built on past successes with more content, new breakout sessions, and the highest attendance to date. Presentations highlighted key industry trends affecting the community along with several opportunities for collaboration that are evolving.

News Facts:

• The third Onsemble conference was held at the National Conference Center in Lansdowne, VA from February 28 through March 2, 2007.
• In attendance were 111 people representing 21 cancer centers, the NCI, AACI (Association of American Cancer Institutes), and CDISC (Clinical Data Interchange Standards Consortium).
• Onsemble is a community comprised primarily of administrators, researchers, biostatisticians, clinicians, assistants, software developers, and other staff from 22 cancer centers nationwide.
• This was the first conference that was opened up to representatives from organizations besides cancer centers and from cancer centers that don't currently use Oncore.
• Guest speaker, Dr. Kenneth Buetow, Director of NCI's Center for Bioinformatics and head of the caBIG initiative, provided an overview of the current status of caBIG and took a look ahead. Having marked the end of their pilot phase, the caBIG community is now looking to further their presence in biomedical, clinical, and technology enterprises. In his presentation, Dr. Buetow mentioned several opportunities for synergies that exist between caBIG and Onsemble objectives.
• Guest speaker, Lakshmi M. Grama, branch chief in charge of the National Cancer Institute's Physicians Data Query (PDQ^®) database, gave a presentation on the benefits of registering clinical trials with the PDQ database.
• Guest speaker, Dr. Dave DeMets, chair of the Department of Biostatistics - Medical Informatics at the University of Wisconsin-Madison, presented a case for Onsemble members to get involved with helping NIH define its emerging Clinical Translational Science Award (CTSA) grant program.
• Guest speaker, Julie Evans, director of Technical Services at the Clinical Data Interchange Standards Consortium (CDISC), outlined how the consortium has succeeded in developing global clinical data interchange standards that are ready for implementation and why this is important to clinical research operations.
• Guest speaker, David Dilts, Ph.D., MBA, professor - director of the Center of Management Research in Healthcare at the Owen Graduate School of Management at Vanderbilt University, illustrated how clinical research operations can identify operational inefficiency and how other industries have achieved better balance and increased productivity in spite of declining resources.
• In addition to the five special guest speakers, members of the Onsemble community provided 14 presentations throughout the three-day conference.
• Also new to this conference was a half-day reserved for concurrent breakout sessions. These sessions were provided to give smaller groups of people with similar job roles an opportunity to network and focus on topics specifically related to their job priorities.
• Updates were given on three new collaborative efforts which were launched during the latter part of 2006 as part of a broader initiative to increase study accruals. These projects are the Oncore Patient Screening Database, Clinical Research Flowcharts, and Electronic Submission to the NCI PDQ^® database.
• Many Onsemble member cancer centers use Oncore^®, the industry leader in enterprise-class software for managing clinical trials and the flagship product of PercipEnz Technologies, Inc.

Multimedia Elements:

NCI's PDQ® Cancer Clinical Trials Registry — by Lakshmi Grama, NCI	Cancer Centers' Role in CTSA — by Dr. Dave DeMets, University of Wisconsin - Madison	Update on caBIG™ — by Dr. Kenneth Buetow, NCI
View the Video	View the Video	View the Video
The Value of CDISC Standards for Data Exchange — by Julie Evans, CDISC	The Importance of Balanced Score Card Metrics for Clinical Centers — by Professor David Dilts, Vanderbilt University	Entering the Golden Age of Cancer Informatics — by Srini Kalluri, PercipEnz
View the Video	View the Video	View the Video

About the Oncore People:

PercipEnz Technologies, Inc. is a computer software company that develops and markets specialized, enterprise-class clinical research and biospecimen management systems.

PercipEnz broke new ground with its collaborative product development process. Working with select groups of product users, PercipEnz begins every phase of product development by clarifying the underlying challenges being addressed. The company is host to Onsemble®, a community comprised of administrators, researchers, biostatisticians, research assistants, database administrators, and other staff from research facilities around the country.

Keywords:

Clinical Trials Management, cancer, Software, Specimen Management, Translational Research, SPORE, caBIG, CDISC, metrics

MADISON, WI -- The Oncore People will be at Booth #6 in the exhibition hall. PercipEnz has been invited to give a presentation on Oncore on Tuesday, February 6th at 3:15 p.m. in Room Lincoln 4

MADISON, WI -- The second edition of Onsemble notes, the newsletter of the Oncore community, was published on December 15. With two additional pages, this edition delivers even more great news from around the community. Featured in this edition is an article by Kevin Davis from NCI/NIH, providing valuable insights into the NCI's PDQ cancer clinical trials registry.

This quarterly newsletter is an important vehicle for providing members with updates on other Oncore centers and various collaborative initiatives. Also included in this edition are articles on: the 2007 Spring conference, successful ePRMS implementations, the release of Oncore version 6.0, finding ways to augment accrual, the release of Oncore-BSM, and new features on Onsemble.net

The Onsemble notes newsletter is provided by PercipEnz Technologies, Inc. as a service to the Oncore community. Submissions, corrections, and comments are always welcome. Subscriptions may be requested.

Download PDF Version Now.

November 3, 2006

MADISON, WI -- Building on their years of experience supporting clinical trials management at several of the nation's premier cancer centers, PercipEnz Technologies, Inc. has created Oncore for BioSpecimen Management (Oncore-BSM™). The only biorepository management system of its kind, Oncore-BSM not only provides the tools necessary to administer and audit large biorepositories but it also provides a unique and seamless interface for researchers to interact with biorepository resources as never before.

News Facts:

• Oncore-BSM manages all of the operational needs of a biorepository from collecting and accessioning specimens to distributing and tracking them as they are utilized by researchers.
• The system was developed in accordance with the published caBIG^™ compatibility guidelines and consistent with the relevant portions of the Office of Biorepositories and Biospecimen Research guidelines.
• Oncore-BSM maintains not only specimen and donor information, but also important information about other specimens from the same donor, refined materials (like DNA and RNA from the specimen), derivative specimens, lab results, and annotations of accumulating experimental and clinicopathological data.
• Flexible ad hoc reporting tool supports the generation of Working Lists, capacity and usage reports, and the determination of specimen availability and location.
• Oncore-BSM is designed to either stand alone or link seamlessly with PercipEnz's well-established and popular oncology research management system (Oncore-ORM^™) to create a comprehensive, integrated cancer informatics platform.
• By using standard protocols and vocabularies, and by conforming to published guidelines, this entire platform also easily integrates with other systems and analysis tools.
• Designed to meet the day-to-day operational needs of the biorepository, Oncore-BSM provides transparency to important functions like specimen chain of custody auditing.
• This flexible system supports specialized specimen handling for correlative studies as well as prospective banking.
• Oncore-BSM supports large organizations wishing to implement a unified banking strategy in centralized or distributed environments.
• Oncore-BSM utilizes the security controls established in the Oncore clinical trials management system to provide compliance with HIPAA and other regulatory and institutional policies.
• Three NCI designated comprehensive cancer centers collaborated with PercipEnz Technologies to develop Oncore-BSM: The University of Wisconsin Comprehensive Cancer Center, Case Comprehensive Cancer Center and Vanderbilt - Ingram Cancer Center.

Multimedia Elements:

Download Product Brief	Request Access to Video Presentation	Read Newsletter Article

About the Oncore People:

PercipEnz Technologies, Inc. is a computer software company that develops and markets specialized, enterprise-class clinical research and biospecimen management systems.

PercipEnz broke new ground with its collaborative product development process. Working with select groups of product users, PercipEnz begins every phase of product development by clarifying the underlying challenges being addressed.

The company is host to Onsemble®, a community comprised of administrators, researchers, biostatisticians, research assistants, database administrators, and other staff from research facilities around the country.

Keywords:

Biospecimen Management, Clinical Trials Management, Tissue Database, Tissue Management, Software, Specimen Management, Tissue Core, Translational Research, SPORE

September 27, 2006

MADISON, WI -- Three premier cancer centers have bid farewell to heavy binders, hours standing at the photocopier, paper memos, and treks across campus. This fall, they are revolutionizing the management of their Protocol Review and Monitoring Committees. It's called ePRMS (Electronic Protocol Review & Monitoring System) and it is the result of a concerted effort to address a fundamental challenge facing today's cancer research facilities.

News Facts:

To request access to a video presentation, visit: www.onsemble.net

To download an eBook on this topic click here.

Multimedia Elements:

Request Online Demonstration	Request Access to Video Presentation	Download eBook

Quotes:

"We have had our second meeting with the ePRMS system, and committee members are very pleased with the ease in which reviews can be completed. The meetings run smoothly and are on time." -- Beth Golden, RN, BSN, Director, Clinical Trials Office, Karmanos Cancer Institute.

"We just had our first SRC meeting using ePRMS and the response was overwhelmingly positive. We are now one hour past the meeting and we have every reviewers' notes except one this typically takes a week or longer!" -- Erin Pennington, Protocol Development Coordinator at Indiana University Cancer Center

"You can tell how well the collaboration went by the fact that the system is now working at three centers." --Dr. Henry Durivage, Director of Human Research Services at The Cancer Institute of New Jersey.

About the Oncore People:

PercipEnz Technologies, Inc. develops and markets specialized informatics solutions for managing the clinical and translational research enterprise.

By adopting a highly collaborative product development process, PercipEnz gathers, distills and fine-tunes the best ideas from world-class research institutions to deliver solutions addressing key operational challenges.