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Cloud platform supports CRO?s global client base and long-term paperless TMF strategy
The following is excerpted from a Veeva Systems press release.
International Drug Development Institute (IDDI) implemented a pilot of Veeva Systems’ cloud-based Vault eTMF for a phase III clinical trial study in less than four weeks, and the organization was able to define rights, workflows, security models, and life cycles all within that time period. The company will migrate many of its 85 active studies into Vault eTMF later this year followed by 40 new studies through 2014.
As a CRO that collects, analyses, and reports all data from international phase I through IV clinical trials for sponsors throughout the US, 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.
IDDI’s key selection criteria was as follows: cost efficient pricing structure, a framework built on the TMF reference model with full audit trails, an intuitive user interface, and 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,” added 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,” continued 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 was also 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 document management features, audit trails, and auditor role functionality enable IDDI to grant auditors access to a system that contains all of the correct documents for review. “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.