We assist clients in the medical and health research industry, particularly in the community-based provider setting, with the development and testing of new prescription drugs, medical devices and biologics and the evaluation of therapies through retrospective data reviews and observational research. Clients trust us to oversee and guide them at every stage of research and development process, from establishing research infrastructure through the meticulous compliance requirements.
Our nationwide team is adept at designing proactive strategies to protect our clients’ interests and safeguard their innovations while adhering to the highest standards of compliance with the myriad federal and state laws intended to ensure the integrity of research, the safety and privacy of research subjects and collected data, and proper use of federal funding.
We provide clients with an exceptional understanding of the changing dynamics of the regulatory landscape. Our team is experienced in dealing with federal agencies ranging from the Department of Health and Human Services, Food and Drug Administration, Office of Human Research Protections, the National Institutes of Health and more. We counsel clients through new frontiers in healthcare, including precision medicine, genetic research and biorepository and data registry developments.