Trial start-up steps, and overall content management, are Veeva Vault cloud offerings
Veeva (Pleasanton, CA), which started out in customer relationship management (CRM) for pharma sales reps, has been building out its cloud-based offerings for the pharma industry for several years; two years ago it introduced a trial master-file system (eTMF) supported by Vault, its cloud-based document storage and sharing service. Now, as presented at customer meetings in the US and Europe in the past couple weeks, it is broadening its offerings to include Vault Study Start-Up and Vault RIM (Regulatory Information Management).
Study Start-Up is meant to address the steps taken to initiate and engage with clinical trial sites, a time-consuming and overly complex process with today’s resources, according to Veeva. “The life sciences industry has long struggled with manual and inefficient processes for study start-up,” said Kathryn King, vice president of Vault Clinical at Veeva. “Existing solutions managed either documents or start-up activities, but never both together. This created significant challenges in identifying and addressing issues during start-up, resulting in longer study durations and impacting overall time to market.”
Vault RIM “unites submission documents, published dossiers, product registrations, and health authority interactions into a single authoritative source for all regulatory information”—on a global basis, if so desired, according to the company. The Vault RIM suite of applications includes Veeva Vault Submissions, Veeva Vault SubmissionsArchive, and Veeva Vault Registrations. Vault Submissions manages the planning, authoring, review, and approval of documents for submission to regulatory authorities. Vault SubmissionsArchive stores published submissions in a secure, globally accessible repository with integrated document navigation and eCTD (Common Technical Document, which includes product dossier information) submission viewing capabilities.
Vault Submissions has been generally available since 2013, and the other RIM products will be available next month, says Veeva. Both RIM and Study Start-Up connect seamlessly with eTMF, providing a comprehensive tool for managing clinical operations. And there is some crossover between eTMF and other Vault resources, such as PromoMats, which enables the storage, distribution and tracking of promotional materials that pharma companies continually update once a product has been approved.
Veeva is entering a hotly competitive arena in software services; a marketing directory company, Capterra (Arlington, VA) lists 91 vendors of clinical-trial management software alone, including such heavyweights as Bioclinica, Phase Forward (an Oracle subsidiary), ePharma Solutions and Clinipace (regulatory compliance would be another grouping). CROs like Paraxel have their own offerings. But if Veeva’s success in pharma CRM, where it pushed to a leading position by displacing premises-based software providers over the past several years is any indication, the company will find an audience. Already, a top pharma company, and a top clinical research organization have signed on to Study Start-Up, and Veeva says there are over 190 pharma clients of its various Vault offerings.