White Paper: Reducing Clinical Regulatory Risk For Drugs, Biologics And Devices

Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of clinical development through a review of regulatory trends over the past 12 months. The information presented is both across all life science categories (drug, biologic, device) and within each category. A thorough review of all FDA activity in the area of clinical development provides insight into regulatory risks.

Common elements exist in regulatory activity for drugs, biologics and devices regarding causes of regulatory citations. These commonalities further highlight areas of ongoing risk for clinical research/development and provide a means of proactively addressing clinical process gaps. Additionally, regulatory trends highlight areas of concern for clinical investigators and Clinical Research Organizations. This provides sponsors greater insight into regulatory risk of organizations whose services are outsourced as part of clinical initiatives.