Outsourcing Clinical Trials in Pharmaceutical Companies

Vikas is a Clinical Project Manager in Ontario, Canada.

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Topics: Pharmaceutical, Procurement Management, Using PMI Standards

Outsourcing of clinical trials is frequently done by pharmaceutical companies because they don’t have the expertise to run those trials, they need to expedite the timelines, or they are working at capacity. The procurement management knowledge area from A Guide to the Project Management Body of Knowledge (PMBOK® Guide) describes the key steps necessary to successfully do a procurement. In this article, I explore key outsourcing activities for Phase I clinical trials from a PMBOK Guide lens to identify key success factors.

There are various types of Phase I clinical trials that need to be conducted to support product registration. Key categories of such trials/studies include:

• Drug-drug interaction studies (pharmacokinetic/pharmacodynamic: PK/PD)
• Single ascending dose studies (SAD)
• Multiple ascending dose studies (MAD)
• Studies in renal-impaired patients
• Studies in hepatic-impaired patients
• Pharmacokinetic/pharmacodynamic studies to support 505 b (2) applications
• Bioavailability/bioequivalence studies
• Oncology Phase I studies in cancer patients (not covered in this article)

Each clinical trial/study is unique and can be considered a project. The key steps in the outsourcing of a clinical trial/study include:

• Contract research organization (CRO) identification
• CRO selection
• CRO management/conduct
• Close-out/continuation

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