International Drug Development Institute (IDDI), an international functional CRO headquartered in Belgium, replaced its mix of a paper-based trial master file (TMF) and e-rooms with Veeva Systems’ cloud-based Vault eTMF solution, part of Veeva’s Development Suite. As a CRO that collects, analyses and reports all data from international phase I through IV clinical trials for sponsors throughout the U.S., Europe and Asia, IDDI wanted a single, centralized system to streamline auditing and collaboration. After evaluating five systems, IDDI chose Vault eTMF for its document tracking capabilities and globally accessible cloud platform.
“We were looking to move from our hybrid system to a single, digital solution for TMF management to improve quality, efficiency and control while allowing our colleagues and clients to access our data through the cloud,” said Linda Danielson, IDDI’s chief operating officer.
Vault eTMF met each of IDDI’s key selection criteria: cost efficient pricing structure, a framework built on the TMF reference model with full audit trails, and an intuitive user interface. Most importantly, IDDI wanted a system that would support its global workforce. “The fact that Vault eTMF is easily accessible without a VPN is very important to us for efficient collaboration across regions,” said Danielson.
“As a CRO, we need our clients to review and approve many of our documents, so it’s critical that we can quickly and easily share them,” said Danielson. “With our old system, clients had to print, sign and scan documents. They then had to upload the documents to a shared e-room or email them back—not an easy or efficient process. It also was difficult to track and to ensure that we received everything back. Vault eTMF enables effective collaboration between both parties since sponsors can review, edit and approve documents in real time.”
“Vault eTMF’s versioning control is key to helping us be prepared for an audit. We know which version we are working on and can automatically provide documented audit trails that show who has accessed which documents and when,” said Danielson.