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 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It is the first statistical software package to incorporate a majority of the requirements in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”.

ADDPLAN is available in the following modules:

  1. ADDPLAN BASE: Adaptive group sequential designs and sample size re‐estimation
  2. ADDPLAN MC: Adaptive multiple comparison procedures
  3. ADDPLAN PE: Adaptive population enrichment designs
  4. ADDPLAN DF: Adaptive dose finding designs (including MCP-Mod)