Vial Announces Strategic Partnership to Build CFR Part 11 Open Source e-Signature Platform with Documenso

SAN FRANCISCO, Aug. 23, 2023 /PRNewswire/ -- Vial, a global tech-driven CRO providing next-generation clinical trial management services, has announced a partnership with Documenso, an innovative open-source digital signing platform. The collaboration marks a significant step forward in revolutionizing document signing practices within the life science sector, providing a compelling alternative to traditional solutions like DocuSign.

In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance. CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA. It lays out guidelines for electronic recordkeeping and signatures, ensuring data integrity and security in regulated sectors such as pharmaceuticals, biotechnology, and medical devices.

"Vial's unwavering commitment to technological advancement has always been at the core of our mission to reimagine clinical trials. Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector. Currently, very few providers offer solutions that align with the rigorous requirements of 21 CFR Part 11. We aim to collaborate with Documenso to develop one of the industry's first open-source document-signing products that meet the demands of 21 CFR Part 11. Together, we are poised to reshape how critical documents are managed and signed, driving us closer to a future where technology empowers every facet of scientific progress," said Simon Burns, CEO and Co-Founder of Vial.

Vial's mission is to reimagine clinical trials to empower scientists to cure all human disease. Vial's driver for accomplishing this mission is applying a technology-forward approach. By deploying technology at every step, Vial is able to drive efficiencies in speed and cost savings for innovative biotech companies of all sizes. The Vial CRO distinguishes itself by leveraging its Vial Technology Platform, TrialOS, combining site start-up, visit data capture, and study analytics into one connected system. These best-in-class CRO services, combined with top vendor partnerships like Documenso, help accelerate the development of new therapies and devices for sponsors and patients.

On the partnership, Timur, CEO, and Co-Founder of Documenso, commented, "Documenso is more than just a digital signing solution; it's a global commodity designed for longevity and scalability. We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions."

About Vial: Vial is a tech-first, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees.

About Documenso: Documenso is a groundbreaking open-source digital signing platform and alternative to traditional solutions like DocuSign. With a strong emphasis on customization and scalability, Documenso seamlessly integrates into business operations, offering extensive options for adaptation and an open API. Documenso was built for longevity and scale by embracing the capital efficiency and inclusiveness of the Commercial Open Source (COSS) movement. Documenso aims to create a global standard for digital signing that prioritizes inclusiveness and innovation.

SOURCE Vial