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- Preparation of Clinical Development Plan
- Providing therapeutic and scientific content for development of study protocol
- Design and implementation of pharmacoeconomic studies
- Preparation, review and approval of regulatory reports, manuscripts, abstracts, posters, and other scientific documents
- Therapeutic and Scientific review of study documents (e.g. informed consent, CRF,IB,CSR,etc)
- Review and approval of medical coding using MedDRA /WHO DD
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