Advarra

Join us 1/26 for a webinar on the latest trends in regulatory and development challenges for rare/orphan diseases. Learn successful strategies for a proactive approach to gaining a rare/orphan disease designation and identify critical issues and steps to resolve them to achieve regulatory and development milestones. CE credits available. Register now!

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Trending Now: Regulatory and Development Challenges to Rare/Orphan Diseases Explore the latest trends in regulatory and development challenges for rare/orphan diseases.

An investigator-initiated trial (IIT) occurs when an investigator creates the idea for a study, develops the protocol, and serves as the sponsor and investigator for the trial. While this isn’t uncommon, careful planning is required in order for these trials to be successfully compliant.

Download our latest eBook: https://bit.ly/3EoEVdc

Regulatory agency guidance in the U.S. and EU strongly recommends keeping DSMBs completely independent from parties sponsoring, organizing, or conducting the clinical trial. Get the unblinded truth on what a DSMB does and how to set one up in this free white paper.

White Paper: Establishing and Operating a DSMB: Tips for Clinical Trial Success This white paper describes how to set up a data safety monitoring board and it's role in clinical research.