Veeva Vault eTMF selected by Princeton-based inVentiv Health Clinical for clinical trial master files


Tom Paine



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inVentiv Health Clinical, a leading global supplier of drug development services, announced last month it will replace its electronic trial master file (eTMF) with Veeva Vault eTMF. Cloud-based, multitenant Vault eTMF, Veeva says, "delivers secure, instant access to inspection-ready documentation and enables seamless collaboration between inVentiv, trial sponsors, and trial sites worldwide - ultimately helping to speed time to submission and product approval."

inVentiv Health Clinical, Princeton, one of the world's largest CROs (contract research organizations), is a unit of Massachusetts-based inVentiv Health.

Vault eTMF is a component of Veeva Vault, a cloud-based platform and suite of integrated content management applications for the life sciences industry. Veeva Vault is a product of Veeva Systems (NYSE: VEEV), the cloud-based life sciences company that is based in Silicon Valley but maintains its east coast office in Radnor. While Veeva's CRM software, its initial and most established offering, is built on Salesforce's Salesforce1 platform, Veeva built Veeva Vault on an entirely proprietary platform.

Vault eTMF is preconfigured with the Drug Information Association (DIA) TMF Reference Model for a repeatable framework across the enterprise. It supports inspection-readiness with workflow, reports, and dashboards, plus features robust audit trails and an auditor role that supports remote inspection capabilities for sponsors and health authorities.

People who follow Veeva Systems have been watching its ability to gain traction for its new offerings as a key indicator of future growth. In Q1 FY 2015 ending April 30,2014, Veeva Vault and Veeva Network (a cloud-based customer master solution) together accounted for more than 10% of revenue, the company reported, after total non-CRM revenue accounted for about 5% in FY '14. Veeva says it now has more than 100 customers on Veeva Vault.

Veeva introduced Veeva Vault more than two years ago, and Veeva Vault eTMF followed somewhat later.

Veeva replaced a major competitor in the eTMF market, EMC Documentum, at InVentiv Health Clinical. Several Philly-area vendors also offer eTMF solutions to varying degrees, including NextDocs, Wingspan, PhlexGlobal, and ePharma Solutions, though Veeva says few others offer both the content management system platform with the clinical healthcare-specific capabilities integrated with it as Vault does.

Many organizations have outmoded systems for eTMF or use combinations of spreadsheets and paper. More than 32% of TMF owners surveyed in the Veeva 2014 Paperless TMF Survey: An Industry Benchmark report released in September report they will grant auditors remote access to their eTMF by early 2015, versus the 16% who provide them access today - a jump of 100%.

When I asked in an interview about future product development plans for Vault, Jennifer Goldsmith, vice president of Veeva Vault, couldn't be specific, but stressed the seamless integration planned within all Veeva Vault offerings, and with other Veeva modules. Also, Veeva Vault is very much a global offering, and its multitenant cloud architecture makes it easier to make local revisions (for language or regulatory information) for specific nations or regions.

In its most recent quarter (Q2 2015 ending July 31), Veeva's total revenues were $75.7 million, up from $49.6 million one year ago, an increase of 53% year-over-year. Net income was $9.6 million, compared to $6.0 million one year ago.


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