Clinical Research

Nelson Hardiman counsels and assists clinical research sponsors and participants with a wide range of business, regulatory, and strategic challenges in clinical research, including:

  • Business Transactions
    • Formation of entities and business structure
    • Institutional Review Board (IRB) compliance
    • Preparation of clinical research study contracts
  • Regulatory Defense
    • FDA investigations and audits
    • Reimbursement audits and investigations by governmental payors, including Medicare and Medi-Cal
    • Defense of clinical researchers for allegations of failure to follow protocols and study requirements
  • Compliance
    • Compliance with Office of Human Research Protection (OHRP) requirements
    • Compliance with billing and coding of experimental drugs and devices
    • Oversight of compliance with consent requirements
    • HIPAA and state patient data privacy and security requirements
  • Litigation
    • Fraud and abuse defense
    • Consent disputes
    • Reimbursement disputes
    • Business litigation