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
- 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.
LOUISVILLE, Ky.—Stites & Harbison, PLLC attorney Mandy Wilson Decker was elected as 2023-24 Chair-Elect of the newly-formed Kentucky Bar Association (KBA) Intellectual Property (IP) Law Section.
LOUISVILLE, Ky.—Kentucky Intellectual Property Alliance (KYIPA) elects Stites & Harbison, PLLC attorney Mandy Wilson Decker as inaugural Chair of its Board of Advisors. She has served on the group’s Executive Advisory Committee since 2021.
LOUISVILLE, Ky.—Managing Intellectual Property (Managing IP) magazine recently selected Stites & Harbison, PLLC attorney Mandy Wilson Decker to the 2023 edition of Managing IP’s “Top 250 Women in IP.” This is the ninth time Decker has been honored on this list, and she is the only attorney honored from Kentucky.