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MetricStream and Salt Lake City-based MasterControl. But Virtify’s technology is differentiated in several ways, Tadikonda says. For one, the company’s software is designed to enable its customers to comply with the standards of regulatory agencies around the world, not just the FDA. It also covers all aspects of the regulatory process including content for clinical trials, product approval applications, and manufacturing. Virtify can also deliver its software to customers as a service via a Web connection, in a software-as-a-service model, or provide the software for companies to host on their own secured servers if that’s what they prefer. The Web-based approach enables Virfity’s customers to easily make updates when regulatory agencies change standards for documentation or formats in which electronic data is kept or shared, Tadikonda says.
Tadikonda founded the company in 2004 with a deep understanding of standards for regulated content in the life sciences industry. Before launching Virtify, he founded a scientific consulting firm called Tribiosys as well as Enmed, a developer of clinical trials and data management systems. During his career, he and his employees have worked on developing some of the standards for maintaining regulated content or sharing health data. Over time, it became apparent to him that many companies weren’t equipped to equipped to handle the management of regulated documents with paper-based systems and previous technologies.
He has built his latest company with people he got to know at previous companies of which he was a founder or an executive. For instance, the executive chairman of the company is Michael Webb, a well-known biotech industry veteran in Massachusetts, with whom Tadikonda worked at Epix Pharmaceuticals (then Epix Medical.) Lexington, MA-based Epix ran low on cash while pursuing a treatment for Alzheimer’s and shut down last summer, well after both Tadikonda and Webb (who is the former CEO of Epix) had left the company.
Indeed, the downfall of Epix is a sobering reminder of the outrageous costs of developing products regulated by the FDA and other agencies. And as long as regulators are amending and churning out compliance standards for life sciences companies, Virtify is likely to have plenty of customers.