November 02, 2015

Veeva Systems Unveils Clinical Trials Study Start-Up Solution

Top 20 pharma and top 10 global CRO sign on as first Veeva Vault Study Start-Up customers

PHILADELPHIA--(BUSINESS WIRE)-- At the Veeva 2015 R&D Summit today, 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.

“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

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.

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About Veeva Vault
Veeva Vault is the first cloud-based regulated content management platform and suite of applications designed for life sciences. It spans clinical, quality, commercial, medical, regulatory, and every major part of a global life sciences company to ensure one trusted source for content and data across the enterprise. Helping companies connect securely in the life sciences cloud, Vault provides complete control from start to finish, as well as the easy accessibility, visibility, and agility needed to speed time to market. All Vault applications offer real-time reporting and dashboards; an intuitive, consumer-web interface; and a true multitenant cloud architecture that continuously delivers rapid innovation. Today, more than 190 customers rely upon Vault to manage their most important content.

About Veeva Systems
Veeva Systems Inc. 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 300 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit

Forward-looking Statements
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the company’s filing on Form 10-Q for the period ended July 31, 2015. This is available on the company’s website at under the Investors section the SEC’s website at Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

Source: Veeva Systems

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