Health Care

Clinical Research, Clinical Trials & Risk Management

Our attorneys understand the unique and complex challenges of clinical research and clinical trials. We represent academic medical centers, teaching hospitals, universities, trial sponsors, life sciences and medical device companies, and other entities involved in clinical research and clinical trials. We provide counsel regarding the numerous and varied agreements and reporting requirements associated with clinical research, including:

  • Master service agreements
  • Confidential disclosure agreements
  • Material transfer agreements
  • Federal and private contracts, grants, clinical and research service agreements
  • Scientific integrity and conflicts of interest
  • Privacy
  • Human subjects protections
  • OIG audits
  • FDA reporting.

Drawing from our extensive experience representing various pharmaceutical and medical device companies, we have the ability to identify and manage risk associated with medical product development, clinical research, clinical trials, and new product launches. Our proactive approach provides advice at all stages of product development, and is directed to reducing risk arising from clinical research, clinical trials, and the resulting products.

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Press Releases

Stites & Harbison Increases Rank on ABA Health Law Section’s Regional Top 10 List for 2020

LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in 6th place in its Eighth Annual Regional Law Firm Recognition List for the South region for 2020.

by Stites & Harbison, PLLC April 14, 2021
Press Releases

Managing IP Selects Mandy Wilson Decker to 2020 “Top 250 Women in IP” List

LOUISVILLE, Ky.—Managing Intellectual Property magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2020 edition of Managing Intellectual Property’s “Top 250 Women in IP.” This is the sixth time Decker has been honored on this list, and she is the only attorney honored from Kentucky.

by Stites & Harbison, PLLC August 07, 2020