Veeva Systems, a cloud-based software provider for the global life sciences industry, has launched its first fully integrated clinical trials study startup solution, Veeva Vault Study StartUp, which will enable life sciences organizations to manage both the content and the activities associated with activating sites for clinical trials. The solution will accelerate time to first patient enrollment, automate manual processes and deliver interoperability with the electronic trial master file (eTMF) for a single source of all 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, the 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 startup is cited by 56% of the respondents as a top driver of eTMF application adoption in their organizations.
“The life sciences industry has long struggled with manual and inefficient processes for study startup,” said Kathryn King, vice president of Vault Clinical at Veeva. “Existing solutions managed either documents or start-up activities, but never both together. This created significant challenges in identifying and addressing issues during startup, resulting in longer study durations and impacting overall time to market.”
Traditional solutions exacerbated the problem by focusing on either site startup documentation or site initiation data, but were unable to bring the documents and data together. Further, the systems were often disconnected from the eTMF applications that also needed the information as part of the trial’s history. The fragmented landscape contributed to lengthy site initiation timelines, a process that, on average, takes 17 months to complete, according to research from the Tufts Center for the Study of Drug Development.
“Sponsors and CROs have typically used unsophisticated, disparate and incompatible proprietary and customized approaches to manage study startup and initiation activities,” said Ken Getz, associate professor at CSDD Tufts University School of Medicine. “This has contributed to the historically high level of inefficiency and inconsistency that we’ve observed in investigative site engagement and activation.”
Vault Study StartUp will bring together site startup documents and initiation in a single solution, while providing seamless interoperability with Veeva Vault eTMF. The 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 StartUp also will provide advanced capabilities to better manage startup processes, including a complete electronic audit trail.