Managing Clinical Risk For The Development Of Drugs And Devices

Managing regulatory risk in an environment of increasing regulatory scrutiny is a critical success factor to consistently develop and launch new products efficiently. 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 for a period of 18 months. The information presented is both across pharmaceutical and medical device industries and within each industry. A thorough review of all FDA activity in the area of clinical development provides insight into regulatory risks. This information is used to:

• Evaluate and review clinical investigators and Clinical Research Organizations (CRO’s).
• Establish improved monitoring programs.
• Ensure proper Investigational Review Board involvement and review.
• Develop effective strategies for managing clinical initiatives.
• Effectively report key clinical information to regulatory authorities.

Common elements exist in regulatory activity for pharmaceuticals and medical 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.