Copernicus Group IRB Announces New Technological Offering to Help Organizations Drive Innovation W

From: Copernicus Group IRB
Published: Wed Sep 15 2010

Copernicus Group IRB (CGIRB), a leading independent institutional review board, today announced the immediate availability of CGIRB Connexus™, its advanced integrated electronic document management web portal, comprehensive tracking database and paperless document repository. Connexus provides study managers with unprecedented new capabilities to efficiently and effectively manage the entire IRB review process.

The Connexus system provides clients and their investigators with secure 24/7 online access to all files and forms, including a comprehensive archive of previous studies and status updates—the first of its kind. This state-of-the-art solution captures and manages every phase of IRB documentation, streamlining and enhancing the way sponsors, investigative sites, CROs and review boards conduct IRB submission and review—helping to keep the review process on schedule.

"New tools and advancements that can contribute to more efficient and secure review processes, particularly in research-intensive academic medical centers, will always be important contributions to IRBs," said Barry Mangum, Director, Clinical Pharmacology at the Duke Clinical Research Unit. "We are hopeful that this system will be shown to be effective in contributing to a speedier process for evaluating proposed clinical trials."

Connexus is fully validated, FDA 21 CFR Part 11 compliant and provides a full audit trail, enabling client organizations to fulfill any regulatory demand quickly and completely.

"Connexus builds on our commitment to use technology to constantly improve our client service level while maintaining the personal contact that Copernicus is so well known for." said Bruce Tomason, CEO of CGIRB. "The official launch of Connexus comes just after our successful transition to a totally paperless environment and our recently concluded legacy document scanning operation, in which we digitized more than 1.5 million documents, or 5 million pages, all of which are searchable. No other IRB has even attempted this kind of project, and our conversion was a complete success."

Connexus enables CGIRB and its clients to work efficiently with the highest level of quality as they review clinical studies, in their own workspace environment, by providing the ability to upload documents, access status tracking updates, assist in continuing review coordination and retrieve all previous study information and documentation. In addition, the sophisticated virtual storage system at the core of Connexus guards against loss of organizational knowledge and wasteful duplication due to staffing changes, misplaced documents, human error or other unforeseeable circumstances.

"Managing Complexity Through Innovation" describes the industry-leading approach that CGIRB has taken in launching Connexus. "Most IRBs today offer little more than a portal, which is simply a way to upload documents as part of the review process," said Jennifer Sodrel, Director of Information Management at CGIRB. "Connexus provides clients with a completely integrated paperless solution to the entire submissions and review process from start to finish for new study submissions as well as electronic access to all legacy documents for all ongoing and open studies that in some cases may go back to the year 2000."

CGIRB has full AAHRPP accreditation and ISO 9001 certification. Connexus cements CGIRB's leadership in excellence and quality and was named a finalist in the Records Management & Compliance category of the 2010 ACE Awards presented by ECM Connection magazine.

About Copernicus Group IRB
Experience and innovation in ethical review™

Copernicus Group IRB, established in July 1996, is a leading independent institutional review board, ensuring the rights and welfare of research study participants. CGIRB provides ethical review of research protocols, investigator/subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004 and ISO 9001:2008 certification in 2010.


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Rebecca Sipes, Copernicus Group IRB
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P.O. Box 110605
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(888) 303-2224 Ext. 151

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Company: Copernicus Group IRB
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