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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Clinical pharmacologist

Global pharmaceutical company

A global pharmaceutical company engaged our services as experts in early-stage drug development projects to act as a clinical pharmacology team leader to take on the leadership of a team of 6 clinical pharmacologists. The team were responsible for progressing 15 clinical trials per year through phases I and II in the therapeutic areas of oncology, rheumatoid arthritis, cardiovascular, CNS, HIV and dermatology. In addition to the man management activities of the project team, key activities included working with the client’s medical team to design clinical pharmacology studies (single ascending dose studies, multiple ascending dose studies, food effect studies, studies in the elderly, and special patient populations) and all aspects of operational study management through Phase I clinical trial units, including resourcing, budgeting and CRO selection, protocol implementation and study report compilation.

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