ELECTRONIC TRIAL MASTER FILE (ETMF) MARKET ANALYSIS

Key Developments

• In November 2023, Egnyte, a leading provider of cloud content management and governance solutions, announced the launch of a new Quality Control feature for its electronic Trial Master File (eTMF) application. This feature empowers users to conduct review and approval workflows directly within the eTMF application before formally archiving sensitive trial content into the TMF, eliminating the complexities associated with managing operations across multiple systems.
• In February 2023, Vial, a tech-enabled next-generation contract research organization (CRO) serving small to mid-sized biotechs, announced a partnership with Egnyte to integrate the latter's Life Sciences electronic Trial Master File (eTMF) solution into Vial's clinical trial platform. Egnyte's eTMF is designed to meet the needs of emerging and midsize biosciences companies. It is a 21 CFR Part 11 compliant platform that reduces document processing times, maintains compliance, and increases audit readiness for life sciences companies.
• In September 2022, Montrium, a leading provider of cloud-based solutions for clinical trial management, launched its expert-led trial master file (TMF) services along with a new TMF maturity educational training program. These innovative offerings aim to support clinical operations and TMF teams throughout every phase of the clinical development journey.
• In June 2022, Anju Software, a leading provider of clinical technology solutions, introduced eTMF Master, a groundbreaking cloud-based electronic Trial Master File (eTMF) software. This innovative solution is designed to facilitate seamless collaboration among sponsors, Contract Research Organizations (CROs), and trial sites by offering an efficient and secure platform for managing clinical trial content in full compliance with regulatory standards.
• In August 2021, Alimentiv, Inc., a global contract research organization (CRO) specializing in gastrointestinal clinical trials, announced a partnership with Veeva Vault eTMF. This partnership enables sponsors to securely access all clinical documentation in real-time throughout the clinical trial lifecycle. Alimentiv adopted Vault eTMF as part of its technology modernization strategy, aiming to enhance the efficiency of clinical trial workflows and provide real-time transparency into the status of the Trial Master File (TMF). The Vault eTMF fully supports the TMF Reference Model, facilitating quick and easy document retrieval for Alimentiv and its partners.