Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor. Delivery delays or under-projection of needed quantities could have a negative impact on timelines, budgets, and patients relying on new treatment options for unmet needs. In this article, learn seven strategies to help you avoid clinical supply delays.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the U.S., an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Israel.