LIFE SCIENCES INDUSTRY / LIFE SCIENCES CLINICAL STUDIES & RESEARCH INTEGRITY
Scientists spending months or years devoted to their work have an ally in ensuring their projects meet all of the standards for possible use and application.
Dinsmore’ s clinical studies team engages with clients at every stage of research to assure regulatory compliance with internal procedures and external standards. Our life sciences attorneys have strong medicolegal backgrounds that include professional experience and practice as former medical researchers, scientists, and certified clinical ethicists. We counsel clients to ensure their research programs are conducted in accordance with federal and state regulations and guidelines, including HHS Office for Human Research Protections (OHRP) for research conducted at Federalwide Assurance-compliant institutions, as well as NIH, USDA, OLAW, FDA, and sponsor-specific policies.
Clients benefit from our deep knowledge and experience handling conflict of interest disclosures, research-related HIPAA reviews, bioethical case analysis, material transfer agreements (MTA), non-disclosure agreements (NDA), and evaluations of regulatory submission related to clinical studies. We also assist in negotiations with the FDA and other regulatory agencies and provide a wide range of clinical research and regulatory compliance consulting services.
Our experienced clinical studies team counsels clients to: