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 2022 “Top 250 Women in IP” List for Eighth Time

LOUISVILLE, Ky.—Managing Intellectual Property (Managing IP) magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2022 edition of Managing IP’s “Top 250 Women in IP.” This is the eighth time Decker has been honored on this list, and she is the only attorney honored from Kentucky.

by Stites & Harbison, PLLC June 13, 2022
Press Releases

Stites & Harbison Named to 2022 Top 10 Patent Firms in North America – South List

LOUISVILLE, Ky.—The Patent Lawyer Magazine has named Stites & Harbison, PLLC to the 2022 Top 10 Patent Firms and IP Practices in North America – South list.

by Stites & Harbison, PLLC May 16, 2022
Press Releases

KYIPA Names Mandy Wilson Decker to Executive Advisory Committee

LOUISVILLE, Ky.—Kentucky Intellectual Property Alliance (KYIPA) names Stites & Harbison, PLLC attorney Mandy Wilson Decker to its Executive Advisory Committee.

by Stites & Harbison, PLLC August 11, 2021