At the Veeva 2015 R&D Summit today, Veeva Systems Inc (NYSE:VEEV) 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.
“The life sciences industry has long struggled with manual and inefficient processes for study start-up,” 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 start-up, resulting in longer study durations and impacting overall time to market.”
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.
“Sponsors and CROs have typically used unsophisticated, disparate, and incompatible proprietary and customized approaches and eClinical solutions to manage study start-up 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 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 today 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. For details, or to arrange an interview, contact [email protected].
In other news from the Summit, Veeva announced its partnership with UL EduNeering to integrate Vault QualityDocs with ComplianceWire®, a leading learning management system that has been used to train more than 35,000 FDA investigators. Aligning training curriculum with regulated content increases inspection readiness and overall quality. (Original Source)
Shares of Veeva Systems closed last Friday at $25.37. VEEV has a 1-year high of $33.66 and a 1-year low of $22.11. The stock’s 50-day moving average is $25.11 and its 200-day moving average is $26.38.
On the ratings front, Veeva Systems has been the subject of a number of recent research reports. In a report issued on October 8, William Blair analyst Amanda Murphy maintained a Buy rating on VEEV. Separately, on October 1, Leerink Swann’s Steven Wardell reiterated a Hold rating on the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Amanda Murphy and Steven Wardell have a total average return of 1.9% and 2.0% respectively. Murphy has a success rate of 59.3% and is ranked #1840 out of 3808 analysts, while Wardell has a success rate of 56.3% and is ranked #1955.
Overall, 2 research analysts have assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $30.50 which is 20.2% above where the stock closed last Friday.
Veeva Systems Inc is a provider of industry-specific, cloud-based software solutions for the life sciences industry.