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Assessing Outsourcing Oversight Practices and Performance.

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This study reveals inconsistent clinical development outsourcing practices across companies of all sizes, with a need for improved oversight. Enhancing executive involvement and technology adoption can boost performance and collaboration in outsourcing models.

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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.