Parker Poe attorneys have assisted facilities, clinical laboratories and physician groups to establish and grow clinical trial programs. Participation in clinical trials can offer a number of professional and economic benefits, but as with any healthcare venture, there are also a number legal requirements and areas of risks associated with clinical trial programs.

Our services in the clinical trial area include the development of clinical trial agreement templates, development and institution of compliance plans for clinical trial operations, and negotiation of clinical trial agreements with sponsors and trial administrators. We have also assisted clients to develop proposals for the establishment of clinical trials with respect to existing drugs or technologies for a new purpose or for use in a new manner, worked with institutional review boards, prepared authorizations and revised policies and procedures consistent with HIPAA laws governing research activities, and advised clients regarding the confidentiality, patent law and related intellectual property considerations that are part of the clinical trial process.

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