Industries & Practices

Clinical Research

Clinical Research

    We work with many health care providers that participate in clinical research trials.

    Advising on a variety of operational, HIPAA privacy and compliance topics, we regularly counsel health care providers engaged in clinical research.

    Projects include:

    • Review and negotiation of clinical trial agreements; material transfer agreements; data use, collection and disclosure agreements; IRB reliance agreements and principal investigator compensation/employment agreements
    • Development and revision of informed consent forms
    • Review and revision of clinical research conflict of interest policies
    • Advisement on clinical research billing issues
    • Development of clinical research compliance program policies and procedures
    • Advisement on operational, compliance, fraud and abuse, HIPAA privacy, and other legal topics related to clinical research