Cloud-based IT offering manages control of marketing and education documents

Patient inserts, med-ed documents and related promotional materials are an obvious example of life sciences “controlled documents”—content that is regulated (in this case, by FDA’s Division of Drug Marketing, Advertising and Communication, DDMAC). Bio/pharma doesn’t just have to keep a copy of these materials on hand; it needs to be able to track the document’s evolution and versions, and to retrieve outdated materials from wherever they may be when FDA requires revision. DDMAC has been very energetic in the past couple years on issuing warning letters on the task.

Now, Veeva Systems (Pleasanton, CA), the same folks that brought Salesforce.com’s software-as-a-service (SaaS) capability to sales automation, is targeting content management systems (CMSs) as a new opportunity. Veeva Vault, built from scratch by Veeva, will provide a cloud-based platform for managing many types of controlled documents in life sciences. The initial target will be marketing and promotional materials; applications for clinical R&D, Trial Master File, Quality, Medical Information, and Administration are in the works.

According to Jennifer Goldsmith, VP at Veeva, Vault is the first CMS dedicated exclusively to life sciences applications. There are general business CMSs, such as the well known products of Documentum, Microsoft’s Sharepoint service and others, and dedicated tools for individual applications such as FDA drug submissions. But these are generally built on previous generations of client-server or site-licensed IT technology, whereas Vault is built to make use of cloud computing from the ground up. As with its sales automation product, the SaaS structure of the offering translates into one version that will be updated continuously by Veeva; clients won’t need to purchase site licenses, upgrades or maintenance contracts, but will simply rent the software on a monthly basis.

As with other IT systems for regulated content, a CMS will require FDA validation to comply with GMP guidelines. Goldsmith says that “90%” of the necessary validation documents will be available to a client the moment they turn the system on; the other 10% are site-specific factors that the manufacturer will need to review with FDA. And she says that implementation will proceed rapidly when the system is used. “I’ve had experience where a contract research organization required 3-6 months to install a CMS, and industry can’t afford to spend that much time to get up and running on the work it needs to do.” IT costs for conventional systems can run in the neighborhood of $250,000-500,000 for a small manufacturer, and tens of millions for a major; Goldsmith says that Vault will reduce those costs by 30-50%.