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Feb. 1, 2023

The Anatomy of a Clinical Trial Agreement

By Hannah L. Cross, Michael J. Halaiko, JD, CIPP/E, Alexandra P. Moylan

Compliance Today

In the February edition of Compliance Today, partners Hannah Cross, Michael Halaiko, and Alexandra Moylan provided insight and an overview of the anatomy of clinical trial agreement, or CTA. The trio of authors discussed the basics, contracting, then took a deep dive in to the subject.

"Those involved in clinical trial agreements (CTAs) are intimately aware that the agreements are lengthy, complex to negotiate, and riddled with compliance pitfalls. If new to this area, it may be easy to overlook a key section or consideration in contracting – especially when time is of the essence in developing new products," Cross, Halaiko and Moylan wrote in Compliance Today.

"This article explores the hallmark agreement in the research associated with any investigational product: the CTA."

Copyright 2023 Compliance Today, a publication of the Health Care Compliance Association (HCCA).

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