It's either the biggest thing ever to happen to biotech IT, or the most effective marketing campaign foisted on the life sciences community. SharePoint, like Microsoft itself, elicits head-shaking from detractors, chest thumping from supporters.
"It's a platform for traditional document management," says Dwight Galler, senior director for marketing at Virtify, a compliance solutions provider. "What's needed is a platform for dynamic content compliance and reuse."
Virtify's enterprise content compliance software is unavailable in a SharePoint version, and the company appears in no hurry to get there. Galler offered a DIA preview of its CTTR Enterprise 2.0 software with XML Rules Injection, for trial registration and results reporting, as we reported. It's part of the Cambridge, MA, vendor's Enterprise Content Compliance (ECC) solution. Enterprise 2.0 automates U.S. disclosure compliance; compliance with other regulatory bodies worldwide is expected following the system's Q3 debut.
By contrast, compliance solutions provider Qumas of Cork, Ireland, launched at DIA its aptly named Enterprise Compliance Solution for Microsoft SharePoint 2010. CEO Kevin O'Leary says in a press conference that he recognizes the "game-changing impact" of SharePoint. "This is the single most exciting initiative we've undertaken in our 16 years of business."
The Qumas offering covers the spectrum of compliance content and process management, "from clinical through regulatory, and onto sales and marketing, IT and legal," according to an announcement. Among specific functions covered are manufacturing controlled documents, clinical trial management, regulatory documents, SOP management, change control and policy training.
The lengthy Microsoft booth at DIA was an impressive show of force, including multiple stations of clinical trial apps being demo'd by partner companies.
- see the BioClinica announcement
- here's the Qumas release