With September 27, 2009, less than two weeks away, Virtify is betting that small and mid-sized drug makers are scrambling to meet the FDA's adverse event reporting requirements as they go into effect. The company has unveiled a software-as-a-service solution for managing clinical trial disclosure requirements. The Virtx CTRR Clinical Trial Registry & Results solution automates compliance with global regulatory mandates, according to an announcement.
Virtx CTRR is part of the company's ECC Software Suite, an Internet-based solution for managing content and compliance requirements. CTRR automates internal workflow and data gathering processes, as well as external workflow with various global regulatory agencies. The company says it provides lifecycle management of the disclosure process from internal review through approvals, postings, and results maintenance.
Exec VP Stephen Bergson notes that as global standards and regulatory mandates evolve, life sciences companies need to prepare to meet them. He outlined in an interview last month six steps to content compliance. Step one is to automate processes and workflow to minimize errors and discrepancies. Remaining steps address collaborative authoring and evolving standards.
- here's the announcement
- read the Bergson interview