In Preparation of caBIGtm Silver Compatibility Certification Oncorer is Modularized

Oncore(r), the most widely adopted clinical trials management software system among cancer clinical research centers, is undergoing a makeover. In anticipation of the National Cancer Institute's cancer Biomedical Informatics Grid (NCI caBIG(tm)) Silver Compatibility Certification process for vendor software, PercipEnz Technologies, Inc. is adopting a modular approach by exposing the key modules comprising its flagship product.

"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(tm) 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(tm) 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(tm) 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(tm) program, caBIG(tm) 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(r) 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

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

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. (http://www.percipenz.com) 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(r) (http://onsemble.net) , 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(tm) website: https://cabig.nci.nih.gov/guidelines_documentation.




In Preparation of caBIGtm Silver Compatibility Certification Oncorer is Modularized



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