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

Managing IP selects Mandy Wilson Decker to 2019 "Top 250 Women in IP" List

LOUISVILLE, Ky.—Managing Intellectual Property magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2019 edition of Managing Intellectual Property’s “Top 250 Women in IP.”

by Stites & Harbison, PLLC May 22, 2019
Press Releases

Kentucky Super Lawyers Honors 42 Stites & Harbison Attorneys for 2019

LOUISVILLE, Ky.—The 2019 edition of Kentucky Super Lawyers recently honored 42 Stites & Harbison, PLLC attorneys in the Covington, Frankfort, Lexington and Louisville, Ky., offices. The publication named 33 attorneys to the Super Lawyers list and nine attorneys to the Rising Stars list.

by Stites & Harbison, PLLC December 07, 2018
Press Releases

Stites & Harbison Ranks 5th in the ABA Health Law Section's Regional Top 10 List for 2018

LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC as 5th in its annual “Regional Law Firm Recognition Top 10 list” for the South region for 2018. This year...
by Stites & Harbison, PLLC October 25, 2018