Vial, a technology-first CRO, has announced a partnership with Egnyte, a leader in cloud content security and governance, to integrate its Life Sciences eTMF (electronic trial master file) solution into Vial’s platform. Egnyte eTMF is a 21 CFR Part 11 compliant platform that reduces document processing time, maintains compliance, and increases audit readiness for life sciences companies.
Vial is a global, technology-driven CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors. Vial’s next-generation technology integrates trial onboarding, patient enrollment, site communication, and data collection processes into one connected system. By deploying technology in every step of a trial, we are driving efficiencies in speed and cost that we pass on to innovative biotech startups.
“By integrating Egnyte’s eTMF, Vial will be able to offer our clients the gold standard in eTMF management, compliance, and audit readiness. We’re thrilled to be able to constantly increase the bar in clinical trial technology,” said Joshua Ondatje, Vice President of Clinical Operations at Vial.
With Egnyte for Life Sciences’ eTMF, clinical development professionals can easily create an eTMF to manage the thousands of documents collected through a trial and ensure those documents are properly stored and managed. Vial will be deeply integrating Egnyte’s eTMF automation features into its end-to-end clinical trial technology stack. Vial will be able to offer automated document upload, review, approval, and storage—saving time and money while maximizing compliance.
Egnyte for Life Sciences’ eTMF solution enables clinical development professionals to:
- Simply manage, review, and stay on track with milestones: built on Egnyte’s leading secure collaboration platform, clinical professionals have full visibility into study milestones, allowing their teams to communicate with sites and stick to timelines.
- Be audit-ready and compliant: the solution meets GxP and FDA 21 CFR Part 11 requirements so teams can stay audit-ready and maintain compliance in a cloud-based solution.
- Accelerate TMF creation: reduce the administrative burden for clinical teams to stay organized with predefined reference models and standard artifacts.
“Egnyte’s eTMF solution is designed to meet the needs of the growing class of emerging and midsize biosciences companies,” said Ronen Vengosh, Vice President of Life Sciences at Egnyte. “By capitalizing on the simplicity and ease of the Egnyte for Life Sciences platform, Vial will be able to alleviate the data management burdens associated with trial studies, so clinical teams can focus on their core mission – getting safe and effective treatments to market quickly.”
SOURCE: PR Newswire