Assessing Outsourcing Oversight Practices and Performance

Area of Science:

• Drug development
• Clinical research operations
• Pharmaceutical outsourcing

Background:

• The Tufts Center for the Study of Drug Development updated benchmarks on outsourcing model adoption.
• Assessed current oversight practices and experiences in clinical development outsourcing.

Purpose of the Study:

• To evaluate the adoption and effectiveness of various clinical development outsourcing models.
• To identify areas for improvement in the oversight of outsourced clinical development activities.

Main Methods:

• An online survey was distributed to assess organizational use of clinical development outsourcing.
• Data from 88 individuals were analyzed to understand current practices and satisfaction levels.

Main Results:

• Over half of respondents utilize three or more outsourcing models concurrently.
• Outsourcing practices vary significantly among small, medium, and large companies, leading to inconsistent satisfaction and performance.
• Full-service models are the most prevalent, with oversight primarily focused on risk mitigation and regulatory compliance by middle management.

Conclusions:

• Opportunities exist to enhance outsourcing oversight through increased executive-level engagement.
• Leveraging technology can improve performance monitoring, communication, and collaboration in outsourcing relationships.