San Francisco, California - ARX (Algorithmic Research), the leading provider of digital signature solutions has successfully implemented the CoSign digital signature solution at PRA, a global clinical research organization (CRO). PRA provides services in 80+ countries through its 40+ offices. The company works with clients across all phases of pharmaceutical and biotech drug development on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs.
PRA is in the process of deploying digital signatures throughout its enterprise, and currently several hundred staff have switched from paper/ink-based signing to signing digitally with CoSign. These include employees in PRA's quality, compliance and clinical operations.
"As a regulated company, we've got hundreds of standard operating procedures that are regularly revised and updated, and they usually need at least two signatures - one from the owner of the SOP, and one for the reviewer. Historically, that's been done in paper form, so if the reviewer and the owner weren't in the same place, the process took time and was tedious," explained Bucky Walsh, Executive VP, PRA. "Digital signatures save a lot of time when the person who owns the SOP is in Kansas, and the reviewer is in Germany, and you don't have to ship paper between offices. What used to take three days, in terms of getting a SOP signed, circulated, and signed back, now takes three hours."
Walsh explained that the opportunity to adopt a standard digital signature solution first arose within internal business processes for the need to have demonstrably authentic records authorizing PRA's business activities. A second need stemmed from the regulatory environment, where documentation is required by external regulatory authorities around the world including the FDA, EMA, and other local authorities in the various countries where PRA does business. As such, compliance with 21 CFR Part 11 and other GxP regulations was one of PRA's strictest requirements.
"Large global CROs like PRA derive significant benefit by going paperless and streamlining operations, and digital signatures provide a consistent and controlled strategy for enterprise deployments, as well as enable trusted and secure document exchange with PRA's customers, business partner and collaborators," said Rodd Schlerf, VP Sales, ARX.
A leading global CRO, PRA is transforming clinical trials through its people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. The organization supports its global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
For more information please visit www.prainternational.com.
About CoSign Digital Signatures in Life Sciences
ARX (Algorithmic Research) is a global provider of cost-efficient digital signature solutions for industries such as life sciences, healthcare, government, engineering, and energy. ARX's CoSign digital signature solution fully automates approval workflows, allowing organizations to go paperless, expedite business processes, and eliminate the expenses and time allocations that paper-based signatures require. CoSign is the most widely-deployed digital signature solution in the Life Sciences industry, employed by over 20,000 FDA-regulated organizations including 9 of the top 10 Pharmaceuticals and 6 of the top 10 CROs. Via its standards-based underpinnings, the CoSign digital signature solution ensures signer intent, document integrity and compliance, while significantly streamlining business processes. CoSign creates a truly collaborative environment for the multiple parties involved in the Life Sciences ecosystem, enabling trust of electronic documentation spanning geographic locations and across organizations.
Watch a Digital Signatures for Life Sciences video to learn how life sciences organizations can benefit from CoSign.
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