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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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
Press Releases

Stites & Harbison ranks 7th in ABA Health Law Section's Regional Top 10 List for 2019

LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in 7th place in its Seventh Annual Regional Law Firm Recognition List for the South region for 2019. This year marks Stites & Harbison’s sixth consecutive time being named to the Top 10 list.

by Stites & Harbison, PLLC November 05, 2019
Trademarkology

Federal Trademark Protection for Products Containing Hemp-Derived Cannabidiol (CBD)

As more states begin legalizing marijuana, there remains substantial tension with federal law, under which marijuana is illegal.

by Summer E. Young Ph.D. August 29, 2019