Veeva shakes up clinical, quality management IT landscape

Veeva isn’t the only IT company putting life sciences data into cloud-based data storage, and it has many competitors for applications in clinical research and quality management. But the combination of the two, propelled by the company’s prior success in salesforce automation and document management, points to a change in internal life sciences data-management practices.

Some 600 clients, prospects and industry leaders gathered in Philadelphia at the company’s R&D Summit to ponder these changes. Veeva touted its success in getting new clients for Veeva Vault QMS and Veeva Vault QualityDocs (now in use at 79 life sciences organizations). A varying number of clients are also using Veeva Clinical Suite, with recently introduced Vault EDC (electronic data capture) Vault Study Startup, Vault eTMF (trial master file) and Vault CTMS (clinical trial management system).

Market research by the firm indicates that conveying data from a CTMS to a TMF system is a nagging problem for half of life sciences research organizations; it also cites the explosion of data being reported during trials—Phase III data has grown by 50% since 2000. inVentiv Health, a leading CRO that has been using Vault eTMF, announced the addition of Vault Study Startup. “Combining the Vault platform and with our comprehensive global regulatory and start-up expertise, encompassing high-quality essential document collection and rapid side contracting, enhances our approach to site activation,” said Susan Stansfield, PhD, EVP, Site Centricity Unit, inVentiv, at the meeting. (A “site centricity” business function is telling, in itself, of the complexity of managing trial sites.)

Many of the quality management applications Veeva is talking about are relevant to clinical research; however, the company is also seeking to combine the quality work going on in that setting with others, such as manufacturing and regulatory compliance. Dealing with quality management functions across contract providers adds to the data management problem. Some pharma companies are structured with an enterprise-wide quality management function, but others handle this by each operating unit, such as clinical, manufacturing, distribution and others. A unified IT approach could lead to a unified quality management function.