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Strategic Planning
- Development of a robust
clinical pharmacology plan, including strategic advice
related to guidance documents, regulatory environment,
and industry standards for the therapeutic area.
- Identification of appropriate clinical pharmacology
studies needed for individual drug programs.
- Interpretation of preclinical or early human data as a
guide for next steps in clinical pharmacology programs.
- Proactive risk management planning to identify and
minimize development challenges.
- Review of clinical pharmacology data/decisions that
impact late phase studies.
- Strategic planning for regulatory interactions
associated with clinical pharmacology data.
- Interpretation of industry guidance documents for
individual clinical pharmacology development programs.
- International trial advice and due diligence in
support of expanding studies internationally.
- Planning and execution of Advisory Boards
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