Veeva Systems, Inc. Announces EDC And eSource To Transform Clinical Data Management

BARCELONA, Spain--(BUSINESS WIRE)--Veeva Systems (NYSE:VEEV) today introduced Veeva Vault EDC and Veeva Vault eSource, the first applications for clinical data management on a single cloud platform. Together with Vault CTMS, Vault eTMF, and Vault Study Startup, Veeva is expanding the Veeva Vault Clinical Suite, the industry’s only suite of unified cloud applications to streamline clinical operations and data management, from study startup to archive.

“The drug development process is fraught with delays and inefficiencies due in large part to protocol complexity, operating fragmentation, and the use of disparate point solutions”

In less than four years, Veeva has added more than 120 clinical operations customers, including global deployments of Veeva Vault eTMF at seven of the top 20 pharma companies. Veeva is building upon its track record of innovation and customer success by delivering a modern cloud approach for clinical data management with Vault EDC and Vault eSource. Now life sciences companies will get the high quality data they need faster to accelerate trials.

Since 2000, the volume of data in a Phase III study has risen by more than 50% and the cost per patient for a clinical trial has almost doubled.¹ Traditional electronic data capture (EDC) systems add to this complexity and cost by requiring site staff to spend a significant amount of time managing clinical data. System set-up, maintenance, inflexibility, and a lack of integration have slowed down the pharmaceutical industry’s ability to get clean data and quickly make informed, confident decisions during trials.

“The drug development process is fraught with delays and inefficiencies due in large part to protocol complexity, operating fragmentation, and the use of disparate point solutions,” said Ken Getz, associate professor and director at Tufts University School of Medicine. “The integration of clinical practice and clinical research data, next generation eClinical technology solutions that unify end-to-end clinical processes, and improvements in protocol design execution feasibility will all be critical success factors in driving higher levels of efficiency, performance, and data quality.”

Vault EDC will be a modern and adaptive cloud application and purpose-built for trial processes to speed critical workflows and enable real-time feedback. It will provide an intuitive, consumer-friendly experience for sites, sponsors, and CROs to quickly and easily access data, and be a single point of focus for clinical data and facilitate all trial designs, from the simplest to the most complex.

Customers can deploy Vault EDC as a standalone application or integrate electronic source data (eSource) with Vault eSource to record patient data directly into an easy-to-use mobile application. This will not only eliminate the need to manually transcribe patient data into an EDC system – which can be days or weeks after the patient visit – but will also cut costly and time-consuming onsite source data verification by clinical monitors.

Vault EDC and Vault eSource will be built upon an open cloud architecture that allows them to be used with other third-party clinical systems. When used together, Veeva will offer the first and only integrated solution on a single platform to ensure high quality data at the point of entry in eSource all the way through to the EDC system, helping streamline clinical processes and speed product time-to-market.

“The industry has been forced to settle for clinical data management systems that have been short on innovation and high on complexity,” said Henry Levy, chief strategy officer at Veeva Systems. “Vault EDC and Vault eSource will offer an innovative, integrated approach that will deliver the data quality and real-time access that is needed to make faster, informed decisions and cut the cost and complexity of trials.”

Today’s news signals Veeva’s focus and investment in this important market – which is estimated to be $1 billion globally for EDC alone – to manage clinical data more efficiently and effectively.² The expense impact of this new initiative was reflected in the company’s guidance for fiscal year 2017.

The Veeva Vault Clinical Suite will now include Vault EDC and Vault eSource along with Vault CTMS, Vault eTMF, and Vault Study Startup to become the most comprehensive suite of clinical cloud applications on a single platform. For the first time, life sciences companies can unify clinical operations and data management to streamline end-to-end processes.

In other news, Veeva expanded its clinical leadership team, adding to its already deep expertise in cloud software development, to deliver continued innovation that will solve customers’ most strategic challenges in clinical. Read today’s press release to learn more.

Availability

Veeva Vault EDC is expected to be available in April 2017, while Veeva Vault eSource is expected to be available in December 2017.

Additional Information

For more on Veeva Vault EDC, visit: veeva.com/eu/VaultEDC

For more on Veeva Vault eSource, visit: veeva.com/eu/VaulteSource

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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 450 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/eu.

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, 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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¹ Ken Getz, Clinical Trial Complexity (Tufts: November 2012) and Penelope K. Manasco, M.D., 10 Things to Speed Development, Lower Costs, and Enhance Quality with Existing Clinical Budgets (MANA RBM: 2016)

² Transparency Market Research, E-Clinical Solution Software Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014-2020