Case Study: Copernicus Group IRB achieves paperless compliance, improved efficiency and $160,000 annual savings with Xerox DocuShare

Paperless goal boosts compliance, efficiency, and saves $160,000 annually

Copernicus Group IRB (CGIRB), an FDA-designated independent institutional review board, faced a highly paper-intensive, compliance-driven workflow that forced staff to print, courier and archive millions of pages and produce 22 feet of paper per week. Seeking a secure, Part 11–compliant portal and document-management solution to speed submissions and protect research subjects, CGIRB engaged Xerox DocuShare (with partner Sitrof) to replace paper processes and support long-term integrations with its protocol tracking and sponsor/CRO systems.

Xerox DocuShare and Sitrof implemented enterprise content management with OCR, workflow, electronic signatures and Sitrof’s DocuShare Compliance Module, scanning 5 million pages into a searchable repository and validating the system for 21 CFR Part 11. The deployment made CGIRB fully paperless in under two years, cut audit preparation time by 98%, eliminated routine printing/storage costs (about $160,000 saved annually and an expected $2M+ over the project life), reduced submission time from 1.5 hours to minutes, and enabled faster, more secure reviews and approvals.

Copernicus Group IRB

Jennifer Sodrel

Director, Information Management