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Standardizing on Veeva Vault Enhances Regeneron’s Clinical and Regulatory Operations Processes

DIA 2017 Annual Meeting — Veeva Systems (NYSE: VEEV) today announced that Regeneron Pharmaceuticals (NASDAQ: REGN) is standardizing on Veeva Vault Submissions and Veeva Vault eTMF to further streamline content in clinical and regulatory operations. Veeva’s best-in-class cloud applications are helping Regeneron to speed product development, increase collaboration, and improve compliance.

The combination of Vault Submissions and Vault eTMF enables Regeneron to manage common content on one platform across its regulatory and clinical operations. For example, study protocol documents can be created once and cross-linked between Vault Submissions and Vault eTMF to ensure teams leverage the same, authoritative information and avoid duplicative efforts, ultimately creating greater business efficiency.

“Regeneron is focused on translating leading-edge science into new medicines that will change the lives of patients with serious diseases,” said Jazz Tobaccowalla, chief information officer at Regeneron. “Veeva provides us with the agility and speed we need to keep up with our rapid pace of innovation and get these important treatments to market.”

Regeneron adopted Vault Submissions not only to improve process efficiency among its regulatory team, but also to standardize authoring, reviewing, and approving source documents with other functional areas that previously used other methods.

“Veeva Vault Submissions enables us to do faster, more frequent submissions and, at the same time, improve collaboration and ensure real-time visibility between our regulatory and clinical teams,” said Kelly Gage-Michaels, director of regulatory submission management at Regeneron. “Leveraging Veeva innovation helped us to significantly streamline our regulatory submissions. We completed several submissions on the day we went live, and several more within the first two weeks.”

As a result of the success of Vault Submissions, Regeneron expanded its use of Veeva Vault to include Vault eTMF to help maintain a constant state of inspection readiness throughout its clinical trials. Regeneron standardized on Vault eTMF to manage TMF documents, related information, and processes in the same system, at the same time, as they are being executed.

“Collaboration is key to our success at Regeneron. Veeva Vault eTMF gives all of our employees and external partners a level of access and visibility important to improve collaboration in our trial processes,” added Andrew Allen, director of clinical development and regulatory affairs systems at Regeneron. “Veeva Vault Submissions and Veeva Vault eTMF also help us be inspection-ready and compliant.”

Ranked first in Science magazine’s global Top Employer survey and third on Forbes’ 25 most innovative companies, Regeneron has built a strong reputation through the discovery and development of novel medicines that improve outcomes for patients with serious unmet needs.

“The Regeneron case study is a great example of the value Veeva Vault can deliver in multiple areas of a life sciences organization,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “Creating and managing content is a significant part of the process in bringing new products to market. Veeva Vault is helping Regeneron share clinical and regulatory content seamlessly between their two functions.”

In other news today, Veeva introduced preliminary findings of the Veeva 2017 Unified Clinical Operations Survey, one of the industry’s largest surveys of clinical operations professionals. Read today’s press release or download the full survey report. Veeva also announced that Veeva Vault CTMS is gaining momentum as customers unify their clinical applications, including CTMS and eTMF. Read the press release to learn more.

Additional Information

For more on Veeva Vault Submissions, visit: veeva.com/Submissions

For more on Veeva Vault eTMF visit: veeva.com/eTMF

Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

Follow us @veevasystems on Twitter: twitter.com/veevasystems

Like Veeva on Facebook: facebook.com/veevasystems

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 525 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 veeva.com.

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 April 30, 2017. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. 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.

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