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Today at the Drug Information Association’s (DIA) Annual Meeting, Veeva Systems announced broad industry adoption of its regulatory information management (RIM) solutions, Vault Registrations, Vault Submissions, and Vault SubmissionsArchive. More than 55 life sciences companies including 20 since the Veeva Vault RIM suite was announced late last year have adopted Veeva’s RIM solutions for a single authoritative source of content and data to improve regulatory operations and compliance.
Life sciences companies are struggling with highly fragmented regulatory information environments where each region or affiliate maintains information in multiple systems and spreadsheets, resulting in duplicate data, documents, and effort. However, recent industry research finds those with unified RIM systems for headquarters and affiliates have better process integration, reduced time to submission, and higher user productivity.
Veeva is helping organizations unite submission documents, published dossiers, product registrations, and health authority interactions with a single authoritative source for all regulatory information. Adoption of Veeva Vault RIM is on the rise as companies look to streamline regulatory processes, improve data quality, and respond more quickly and accurately to health authority inquiries.
“The Veeva Vault RIM suite of applications has helped our regulatory operations team achieve optimal efficiency,” said Daniel Takefman, head of regulatory affairs at Spark Therapeutics. “The ability to have a fully integrated, real-time view of regulatory processes has helped us improve efficiencies while maintaining compliance for records management. We’ve greatly improved alignment across our entire organization.”
“The concept of a unified suite of RIM applications is gaining momentum as customers seek greater visibility and global alignment across regulatory activities and a growing ecosystem of stakeholders,” said John Lawrie, vice president of Veeva Vault RIM. “With a single source of truth for regulatory content and data, life sciences companies are achieving productivity and efficiency gains across their organizations.”
Veeva Vault RIM is part of Veeva Vault, a cloud-based content management platform and suite of applications that provide a single source of truth to reduce complexity and increase business agility. Traditionally, companies have had to deploy multiple applications to manage content and the associated data. Veeva Vault is the only content management platform with the unique capability to manage both content and data so that life sciences companies can eliminate system silos and manage end-to-end regulatory processes and content.
Further industry trend data on the impending change ahead for regulatory is available in today’s infographic. To hear about how leading life sciences companies are managing regulatory events and unifying RIM, join the DIA Innovation Theater session: “The Great RIM Throwdown! How Are You Managing Regulatory Events?” on Tuesday, June 28 at 1:20 pm. in Exhibit Hall B, at the DIA 2016 Annual Meeting.
In related news today at DIA, Kinapse selected Veeva Vault Submissions for authoring and managing regulatory submissions content. Read the full press release here. Veeva also released the latest findings of the Veeva 2016 Paperless TMF Survey, which shows that eTMF application use has doubled amid the industry-wide drive to improve inspection readiness and shorten clinical trial time. A presentation on the full research findings will be given at DIA on Tuesday, June 28 at 3:25 pm. in the Innovation Theater, Exhibit Hall B.
About Veeva Systems
Veeva Systems, Inc. (veeva.com) 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 400 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.
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, 2016. 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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