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Agile Computing Authors: Liz McMillan, Elizabeth White, Pat Romanski, Roger Strukhoff, Darren Anstee

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Contract Research Organization Pharma Start Improves Audit Readiness with Paperless eTMF Solution from Veeva Systems

Improving audit readiness is one of the top goals for life sciences companies implementing a new electronic TMF solution today, and Pharma Start is no exception. Since adopting Veeva Systems’ cloud-based Vault eTMF solution, the contract research organization (CRO) is now prepared for inspection at all times and has the visibility needed to establish collaborative relationships with sponsors. Vault eTMF enables real-time information sharing in the cloud between Pharma Start teams, clinical partners, and its 75+ investigator sites around the globe. Additionally, Vault eTMF supports Pharma Start’s steadfast commitment to minimize its carbon footprint by eliminating the environmental impact of shipping paper, especially important in clinical work, where a single study can yield 5,000+ reams of paper a year, equal to 295 or more trees.

“We wanted to find a way to eliminate paper and improve process efficiency while complying with global requirements for a trial master file and adhering to our footprint goal,” explained Tom McGrady, Pharma Start’s vice president of quality assurance. The company turned to Vault eTMF for its flexible cloud architecture, ease of use, and ability to comply with 21 CFR Part 11. Plus, with TMF documents always up to date in Vault’s centrally accessible system, Pharma Start is better prepared for audit at all times. “We had a lot of criteria but Vault eTMF met all of them,” said McGrady.

Pharma Start initially considered other eTMF applications, but a cloud solution proved critical in order to remain true to its environmental goal. An in-depth study conducted by Accenture and Microsoft determined that the average 100-person company can reduce energy consumption and emissions by more than 90 percent by deploying all business applications in the cloud.1 Multitenant cloud applications, specifically, have proven to be greener alternatives to traditional systems, as they serve many customers that would otherwise each utilize their own resources to power, cool, and maintain the required infrastructure. Further, Veeva’s data centers use advanced technologies to optimize temperature control and reduce energy consumption.

“Securely accessible in the cloud and as easy to use as Amazon, Vault eTMF ensures both external and internal teams can fully leverage the system. Everyone can work in parallel so we don’t wait, for example, while physical documents are shipped to sites or a wet signature is captured via courier from locations all around the globe,” explained Rebecca Moraris, Pharma Start’s director of clinical operations. “Vault eTMF also provides total transparency and a better vantage point for sponsors, sites, and internal groups to identify problems early and fix them quickly.”

Since implementing Vault eTMF, Pharma Start has experienced major efficiency gains. “It really comes down to improved productivity,” added Moraris. “With Vault eTMF, processes and workflows can be automated so individual sites don’t have to recreate the wheel but simply pull down a template, complete it, and upload it back into Vault for all to see in real time. Placement into the eTMF happens automatically.”

Moraris continued, “We see tremendous hidden cost savings because TMF documents are uploaded, QC’d, and approved in the system all along the way. For study start-up, there’s less chasing documents and signatures, and at study close-out, we’ll eliminate the painful document reconciliation process.”

Vault eTMF is part of Veeva’s Development Suite, a cloud-based line of integrated content management applications for the life sciences industry. Supporting the R&D process from clinical trials to quality and regulatory submissions, the Veeva Development Suite provides pharmaceutical, biotechnology, and medical-device companies the ability to deploy a single content management system globally.

Pharma Start has joined the many life sciences organizations making the switch from paper to an electronic TMF and is working through the common challenges associated with change. “People always fear change, primarily because they worry about a loss of control. We’ve done training and adjusted our SOPs, but truly the best way to help the team make this transition has been to demonstrate the value of Vault eTMF. As soon as they see how much faster, easier, and more efficient it makes their jobs…change is easy. There’s no turning back now,” concluded Pharma Start President Christina Fleming.

For Additional Information:

About Pharma Start

Pharma Start provides outsourcing services, including preclinical assessment, clinical development, clinical pharmacology, translational medicine, medical writing, and regulatory submission and lifecycle management, supporting global pharmaceutical, biotechnology, and medical-device companies. For further information on Pharma Start, visit: http://www.pharma-start.com.

About Veeva Systems

Veeva Systems Inc. (NYSE:VEEV) 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 200 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 www.veeva.com.

Forward-looking Statements

This release contains forward-looking statements, including statements regarding benefits from the use of Veeva's solutions and general business conditions. 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, 2014, which is available on the company’s website at www.veeva.com under the Investors section and on the SEC’s website at www.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.

1 “Study of Cloud’s Impact on Environment,” commissioned by Accenture, Microsoft and WSP Environment and Energy, November 2010. For more, http://newsroom.accenture.com/article_display.cfm?article_id=5089

® 2014 Veeva Systems Inc. All rights reserved. Veeva and the Veeva logo are trademarks of Veeva Systems Inc. Veeva Systems Inc. owns other registered and unregistered trademarks.

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