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 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
Events

Kentucky Health Law Institute

Date: 9/2/20 - 9/3/20
Time: 8:00 a.m. - 5:00 p.m.

WEBINAR (via Zoom)

Sarah Spurlock, Janet Craig and Dustyn Jones will be presenters at this WEBINAR presented by UK Law Continuing Legal Education on September 2-3, 2020.

Sarah Cronan Spurlock, Janet A. Craig, and Dustyn B. Jones June 30, 2020
Client Alerts

Healthcare Fraud and Abuse Laws are Relaxed During COVID-19

In response to the global COVID-19 pandemic, on March 30, 2020, the Secretary of the Department of Health and Human Services (HHS) issued nationwide blanket waivers of sanctions under the federal physician self-referral law (Stark Law) for “COVID-19 Purposes” (Blanket Waivers).

by K. Kelly White Bryant and Ozair M. Shariff April 13, 2020