IRB automates document processes for protocol review

Independent institutional review board Copernicus Group has announced CGIRB Connexus, a web portal for document management. The system integrates the management of electronic documents with a tracking database and paperless document repository. Capabilities span the IRB processes, the company says.

Connexus provides CROs and investigators with secure online access to current study files and forms, as well as archives of previous studies. The validated Part 11-compliant solution captures IRB documentation for use by sponsors, investigative sites, CROs and review boards in trial protocol submissions and reviews.

The Connexus launch follows two Copernicus digitization efforts: migration to a paperless environment and a legacy document scanning operation that encompasses 1.5 million now searchable documents. Connexus uses a virtual storage system to maintain organizational knowledge and minimize duplication due to staffing changes and human error.

- see the Copernicus Group announcement