Digital signatures improve clinical operations, claims ARX

In the video, ARX claims digital signatures improve clinical operations by expediting site initiation, cutting site monitoring report routing costs, and improving audit efficiency.

The company already provides FDA and GCP regulated digital signature applications, but claims the more widespread implementation of its technology could help clinical research organisations (CROs) and sponsors make significant savings, at a time when trial costs are rising, and patent exclusivity periods are shortening.

“It has become increasingly important for collaborators in clinical studies to securely exchange and trust regulated documentation,” ​said Rod Schlerf, FDA and USDA markets manager for ARX.

“Digitally signed electronic records provide compliant proof of signer identity and document integrity for anyone receiving the signed documents.”​

The San Francisco, US-based firm claims that digital signature technology allows key players in the clinical trials ecosystem, such as site personnel and institutional review boards, to concentrate on the quality of their reports, rather than completing paperwork.

Compliance​

Digital signatures are already in use clinical operations to expedite the signing off of site monitoring reports, electronic Trial Master File regulatory documents, and quality compliance documentation to support audits.

Those audits, says ARX, cost more and take longer when paper records need to be tracked down, compared to a secure, digitally signed repository of electronic records where the desired information is instantly to hand.

“The technology can enhance any mainstream document management system,” ​says ARX, “leveraging its ability to speed up, track and audit the flow of documents in clinical operations.”​

FDA regulated​

ARX claims its proprietary CoSign technology is used by over 10,000 FDA regulated organisations, making it the most prevalent digital signature system in the life sciences industry.

The technology is accepted by regulatory bodies and courts across the world as proof of identity, intent of the signer, and as proof the contents of the document have not changed.