Clinical Research, Population Health Research and Human Subject Protection

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.

Counsel a large healthcare provider in establishing a centralized clinical research program with an infrastructure geared toward regulatory compliance.
On behalf of researchers, commercial sponsors and contract research organizations, prepare, review and negotiate clinical trial agreements, investigator agreements, research services agreements and other related agreements.
Advise academic medical centers on patient privacy protections in the conduct of research.
Advise community-based health systems in regulatory requirements related to Medicare billing of clinical trial costs and assist in developing processes to capture charges in a compliant manner.
Advise community-based hospitals on investigator compensation models.
Advise institutional review boards on regulatory compliance.
Provide guidance to manufacturers on federal Anti-Kickback Statute compliance and Sunshine Act reporting.
Advise financial services corporations and software developers regarding health information privacy.