At the Veeva 2015 R&D Summit, Veeva Systems announced the first fully integrated clinical trials study start-up solution. Veeva Vault Study Start-Up will enable life sciences organizations to manage both the content and the activities associated with activating sites for clinical trials. This comprehensive solution will accelerate time to first patient enrollment, automate manual processes, and deliver seamless interoperability with eTMF for a single source of trial-related content.
Life sciences organizations have made strides in adopting advanced solutions to increase speed and efficiency in many areas of the trial process. According to the 2015 TMF Reference Model Survey, a majority of respondents (61%) are either using or actively planning on using an eTMF. And according to the Veeva 2015 Paperless TMF Survey, speeding study start-up is cited by 56% of the respondents as a top driver of eTMF adoption in their organization.
Traditional solutions exacerbated the problem by focusing on either site start-up documentation or site initiation data, but were unable to bring the documents and data together. Further, these systems were often disconnected from the eTMF applications that also needed that information as part of the trial’s history. The fragmented landscape contributed to lengthy site initiation timelines, a process that, on average, took 17 months to complete, according to research from the Tufts Center for the Study of Drug Development.
Vault Study Start-Up will bring together site start-up documents and site initiation in a single solution, while providing seamless interoperability with Veeva Vault eTMF. This combination of capabilities will ensure a single source of truth for all start-up related content and data. Sites, sponsors, and CROs will be able to access the same clinical information, simplifying collaboration and increasing efficiency. Vault Study Start-Up will also provide advanced capabilities to better manage start-up processes, including a complete, reliable electronic audit trail.
Veeva Vault Study Start-Up will be available in early December 2015. A top 20 pharmaceutical company and a top 10 global CRO have already signed on as early Vault Study Start-Up customers.
Veeva Vault RIM was also announced at the 2015 Veeva R&D Summit. Vault RIM is a next-generation regulatory information management suite that unites submission documents, published dossiers, product registrations, and agency commitments into a single authoritative source for the global organization.
Veeva Systems Inc.
www.veeva.com
