King & Spalding has extensive experience with a wide range of clinical research compliance issues, including drafting clinical research agreements for manufacturers and providers, providing compliance readiness assessments, providing coverage analyses, advising clients on time and effort reporting, developing clinical research policies and procedures, and providing fraud and abuse compliance advice. Our experience in clinical research subject to FDA and OHRP regulations and enforcement is extensive. We assist manufacturers and medical centers in determining whether proposed clinical research involving a drug or medical device is subject to FDA regulations. We assist with preparation of submissions, preparation for meetings, safety reporting, financial disclosures, federal inspections, and management of FDA and OHRP enforcement actions directed against sponsors, investigators and IRBs. We also have experience in representing IRBs in connection with OHRP investigations, and clinical investigators in actions taken by IRBs. We work with manufacturers and medical centers to design up-to-date training programs for physicians, clinical research staff, regulatory officers and counsel to ensure compliance with the DHHS Common Rule and with FDA’s broader clinical trial regulations. Our team’s expertise includes serving on data safety monitoring committees and federal advisory committees, evaluating potential conflicts of interest at institutions performing clinical research, risk-mitigation in trial monitoring, and assisting clients with clinical trial audits and self-disclosures to the National Institutes of Health, FDA or OHRP for compliance- and data integrity-related issues. We also serve as outside advisors to assist clients in establishing clinical research compliance and conflict of interest disclosure protocols for clinical investigators and their institutions.
Our clients include leading academic medical centers and teaching hospitals, large, multi-hospital health systems, acute care and specialty hospitals, pharmaceutical sales and supply companies, physicians and physician organizations, and medical device and pharmaceutical manufacturers.
King & Spalding is also a member of the Clinical Trials Transformation Initiative (CTTI), an FDA-initiated public and private partnership whose purpose includes identification of ways to enhance efficiency and compliance in the conduct of complex clinical trials.