"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
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," 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."
Like all companies involved in clinical trials, IDDI places a high value on audit readiness. 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.
IDDI implemented a pilot of Vault eTMF for a phase III clinical trial study in less than four weeks, and the organisation 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.
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