A: ADDRESSING CLINICAL TRIAL ISSUES individually and through disparate systems is not sustainable. Technology that brings data together and analyzes the information in a comprehensive and centralized manner will not only allow for a much smarter focus but will also lead to a better understanding of root causes of performance and quality issues as well as provide key indicators to enhance oversight. Centralized monitoring and risk-based approaches to trial oversight, as suggested in the revision to ICH E6 (R2) and in the FDA guidance on risk-based monitoring, are supported by such technology. Strengthening the clinical operations arena today through technology is more costfeasible than in previous years. And while technology can empower clinical operations teams to focus attention on areas of greatest need, no technology is effective without the expert judgment of a well-trained and educated clinical operations staff.
MITCHELL KATZ, PH.D.
Mitchell has 30 years’ experience in the pharmaceutical and biotechnology industries, including preclinical research, pharmaceutical operations, and regulatory affairs. He is the Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P.