Bellberry is further developing guidance with respect to complex study designs (such as platform, adaptive and umbrella protocols), which includes how these applications are presented to our Committees for review.
Aligned to our purpose, the quality of a Bellberry Committee review is part of the foundation of our service. While we acknowledge complex study designs have many advantages, there are additional considerations for the management of these types of study designs, ultimately with the protection of participants in mind.
We encourage sponsors and sites planning a complex study design to reach out to the Bellberry team to discuss their application ahead of submission. If you have any queries please contact our team at bellberry@bellberry.com.au