CTTI’s New Recommendations for Data Monitoring Committees

Today, The Clinical Trials Transformation Initiative (CTTI), released recommendations and best practices for the use of Data Monitoring Committees (DMCs).  Congratulations to Berry Consultants team members, Dr. Roger Lewis and Dr. Jason Connor, for participating and providing their expertise as part of the CTTI team releasing these new recommendations.  For the full article, see CTTI's website here.  For the full recommendation report, see direct link here.

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February 2024 QUOTES Webinar

Berry Consultants will be hosting a webinar on the optimization of a clinical trial design by estimating its impact on the expected net present value of a drug development program using the software QUOTES (Quantification and Optimization of Trial Expectations Simulator).

Blog: Precision Promise Adaptive Platform Trial update

Blog by: Kert Viele News from the Precision Promise platform trial. https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-completion-pamrevlumab-arm-precision-promise Precision Promise is an adaptive platform trial investigating potential therapies for pancreatic cancer,

January 2024 FACTS Webinar

The Berry Consultants software team will be hosting its January FACTS webinar next Friday, January 19th at 11am EST to present the development plans for adding an ordinal endpoint option to the trial simulator.

Blog: Comments on the draft FDA master protocol guidance

Blog by: Kert Viele The FDA draft master protocol guidance is out https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-drug-and-biological-product-development Comments are due by February 22. Here are some preliminary thoughts and