Clinical research compliance is another premiere industry focus of King & Spalding’s Healthcare Practice. We have extensive experience counseling our clinical research clients on a wide range of issues, including drafting clinical research agreements for pharmaceutical and medical device manufacturers, providing coverage analyses, advising clients on time and effort reporting, and providing fraud and abuse compliance advice. Our attorneys’ expertise includes service on institutional review boards, evaluating potential conflicts of interests at institutions performing clinical research, and assisting clients with self-disclosures to the National Institutes of Health for compliance related issues. We also serve as outside advisors to assist clients in establishing research compliance protocols.
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.
