Clinical Trials / Human Subjects Research

Clinical Trial Agreement (CTA) Provisions should be carefully reviewed and negotiated to insure the party’s interests are protected. The roles, responsibilities, and liabilities of each party must be delineated before any trial is undertaken. Intellectual property (IP) rights, including those related to the product, the delivery system, any improvements a well as data ownership and publication rights are key considerations. In addition to negotiating interests and risks and protecting IP, requirements for FDA and country-specific regulatory submissions and audits must be met. Whether you need help negotiating CTAs, CRO Service Agreements, Strategic Alliance Agreements, Material Transfer Agreements, clinical trial supply and distribution agreements, or coordinating development of clinical trial protocols, our approach is modeled on the best practices of major pharmaceutical companies. Frier Levitt assists different stakeholders in the clinical trial industry to make the contracting part of clinical trials a manageable and controllable process. We apply efficiencies and create solutions to improve timelines while maintaining quality of the contracts involved.

Clinical research implicates an overwhelming number of legal and ethical issues, including contract considerations, informed consent, patient privacy and HIPAA concerns, budgeting and billing compliance, and financial disclosures.

Frier Levitt understands the unique challenges facing physician-investigators, who often lack administrative support and whose primary focus is on substantive care for patients. The regulations governing human subject research are multifaceted and complex and the missteps can result in severe consequences.

Frier Levitt attorneys have an in depth knowledge of the rules and FDA regulations surrounding human subjects research and regularly counsel physicians and academic institutions on the controversial and complex legal issues intertwined with scientific development. We can help you or your institution navigate the broad range of topics that arise in the clinical trials setting and develop processes and procedures to ensure that your clinical trial, or your participation in a sponsored trial, is fully compliant with applicable laws and regulations.

Our multidisciplinary team of attorneys understands not only the rules and FDA regulations governing clinical research, but is also well versed in Federal and State anti-kickback and fraud and abuse laws that are often, and sometimes unknowingly, implicated in the clinical research setting. We assist clinical researchers with all facets of a clinical trial including:

  • Negotiating and drafting clinical trial agreements and other contracts with study sponsors to ensure compliance with Federal and State law
  • Assistance with budget development and establishing procedures to ensure billing compliance with Medicare and other third-party payor requirements
  • Preparing Institutional Review Board (IRB) submissions
  • Drafting Patient Informed Consent Forms and HIPAA Agreements
  • Patient Recruitment
  • Conflict of Interest Disclosures
  • Data Integrity
  • Intellectual Property
  • Ensuring adherence to the principles of Good Clinical Practices (GCPs)

Contact Frier Levitt today for assistance with your clinical research needs.