Tech-enabled, next-generation contract research organisation (CRO) Vial has announced a partnership to integrate Egnyte’s Life Sciences electronic trial master file (eTMF) solution into its clinical trial platform.
Egnyte eTMF minimises document processing times and maintains compliance while increasing audit readiness for life sciences companies.
Vial Clinical Operations vice-president Joshua Ondatje said: “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.”
Leveraging Egnyte’s solution, clinical development professionals will be able to create an eTMF for managing several documents that are gathered through a trial.
Additionally, the professionals can ensure proper storage and management of these documents.
Vial will integrate the automation features of the solution into its end-to-end clinical trial technology stack and can offer automated document upload, review, approval, and storage.
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By GlobalDataWith the help of the eTMF solution, clinical development professionals can simply manage, review, and stay on track with milestones and expedite TMF creation.
The eTMF solution meets GxP and FDA 21 CFR Part 11 requirements and helps the professionals stay audit-ready while maintaining compliance in a Cloud-based solution.
Egnyte Life Sciences vice-president Ronen Vengosh said: “Egnyte’s eTMF solution is designed to meet the needs of the growing class of emerging and midsize biosciences companies.
“By capitalising 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.”
In November last year, Vial added Next Oncology, a worldwide Phase I cancer research clinics network, to its Preferred Site Network.