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- Legal
advice and counseling on federal and state laws governing the conduct
of clinical research.
- Negotiation of clinical trial agreements, CRADAs
and other technology transfer agreements for drugs, medical devices
and dietary supplements.
- Development and negotiation of contractual agreements
and other administrative and regulatory documents such as investigator
and site agreements.
- Consultation on the clinical development process,
including human subjects protection issues, such as recruitment practices
and informed consent.
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