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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.

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