San Francisco, California, April 12, 2011
ARX (Algorithmic Research), the leading provider of digital signature solutions in FDA GCP regulated applications, has recently released a 2-minute video entitled “Improving Clinical Operations with Digital Signatures.” The video highlights how key players in clinical operation environments can benefit by implementing a digital signature solution.
As the expenses and time required for clinical trials continue to rise, sponsors and clinical research organizations (CROs) are faced with shorter patent exclusivity periods and lost revenue. To address this issue, life sciences organizations are adopting technologies to increase efficiency and enable clinical sites to be initiated and monitored using fully electronic processes. Digital signatures enable sponsors, CROs, site personnel, institutional review boards (IRBs) and other key players in the clinical ecosystem to electronically sign and submit reports and other documents, enabling regulatory compliance while driving significant time and cost savings.
“It has become extremely important for collaborators in clinical studies to securely exchange and trust regulated documentation,” explains Rodd Schlerf, FDA and USDA Markets Manager, ARX. “Digitally signed electronic records provide compliant proof of signer identity and document integrity for anyone receiving the signed documents.”
Digital signatures in clinical operations are being used for quickly and compliantly signing off on site monitoring reports, electronic Trial Master File regulatory documents, and quality and compliance documentation used to support audits. By automating approval workflows, digital signatures enable organizations to expedite business processes, and eliminate the expenses and time allocations that paper-based signatures require. In the life sciences industry, CoSign® is the most widely-deployed digital signature solution, used by over 10,000 FDA-regulated organizations. To learn more about how CoSign digital signatures improve clinical operations, watch the 2-minute video.
