ADDPLAN

ADDPLAN® Software. ADDPLAN is fully validated, 21 CFR Part 11 compliant statistical software, for the design, simulation and analysis of adaptive clinical trials. It combines the key features of planning and conducting a sequentially planned clinical trial within a user-friendly interface. ADDPLAN is currently used by regulatory agencies, including the including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals & Medical Devices Agency (PMDA), as well as over fifty top pharmaceutical and medical device companies and numerous leading academic researchers. It is the first statistical software package to incorporate a majority of the requirements in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”. Examples include the use of multiple comparison procedures for multi-armed adaptive trials, including treatment selection designs, flexible combination of clinical research phases, and patient enrichment designs.

Keywords for this software

Anything in here will be replaced on browsers that support the canvas element