Clinical research contracting and compliance
Review clinical trial agreements and related documents, including non-disclosure agreements and informed consent forms, for hospitals engaged in the conduct of clinical research. Advises hospital on critical provisions in clinical trial agreements, including subject injury, intellectual property, publication and indemnification. The firm has also assisted clients with a variety of compliance issues related to clinical research, including the Common Rule, billing, the Sunshine Act, conflicts of interest, FDA regulations and HIPAA.