Copernicus Group IRB (CGIRB), with assistance from Sitrof and employee-driven change management, was able to transform from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization in less than two years. As a result, the company dramatically reduced expenses and created a truly “green” work environment by nearly eliminating paper, printing, storage, shipping and other hard document handling costs.
With a three-phase implementation approach, employee-led review and oversight committees, CGIRB fostered a positive, productive atmosphere for long-term change management. CGIRB gained competitive advantage and improved service to pharmaceutical clients by becoming more efficient in review and approval process—thus enabling clients to accelerate their study start up and increase the speed in getting drugs approved and into the market.
In the fall of 2006, CGIRB sought a document management solution to handle incoming electronic documents so they did not have to be printed and circulated in hard copy. It approached Sitrof Technologies, a company specializing in unstructured document management with extensive experience Part 11 compliance. CGIRB wanted to install a 21 CRF Part 11 compliant document management system with workflow, version control and electronic signatures to handle incoming documents.