BARCELONA, Spain--(EON: Enhanced Online News)--International Drug Development Institute (IDDI), an international functional Contract Research Organisation (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 US, Europe, and Asia, IDDI wanted a single, centralised system to streamline auditing and collaboration. After evaluating five systems, IDDI chose Vault eTMF for its document tracking capabilities and globally accessible cloud platform.
“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”
"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. "We were very impressed with Veeva's successful track record in the life sciences industry. Veeva also came with strong references for customer support and cloud technology innovation."
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.
"Veeva's professional services team was very easy to work with, fast, and responsive. We were extremely happy to be up and running with a solution that fully met our business requirements so quickly," concluded Danielson.
About Veeva Development Suite
Vault eTMF is part of the Veeva Development Suite, the only cloud-based suite of integrated content management applications for the life sciences industry. Spanning every major part of a life sciences company – from R&D and clinical trials to quality and manufacturing – the Veeva Development Suite gives pharmaceutical, biotechnology, and medical device companies the ability to deploy a single content management system globally. All Development Suite applications offer real-time reporting and dashboards, an intuitive web interface, and a true multitenant cloud architecture that continuously delivers rapid innovation.
IDDI offers advanced biostatistical and eClinical services to pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology. IDDI optimises the clinical development of drugs, biologics and devices thanks to proven expertise and operational excellence. Founded in 1991, IDDI is a privately owned company headquartered in Louvain-la-Neuve, Belgium with offices in Boston and Houston, USA. For more information visit www.iddi.com.
About Veeva Systems
Veeva Systems is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 170 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Budapest, London, Paris, Beijing, Shanghai, Osaka, Tokyo, Sydney, and Singapore. For more information, visit www.veeva.com.