Adaptive Design Perfected.

ADDPLAN is part of the ICONIK Informatics Hub, using data to design, simulate, and analyse adaptive clinical trials with ease.

Fully validated and compliant

ADDPLAN is fully validated, 21 CFR Part 11 compliant and offers clients the benefit of using the first statistical software package to incorporate a majority of the requirements in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”.

User-friendly features

ADDPLAN combines the key features of planning and conducting a sequentially planned clinical trial within a user-friendly interface.

Used by leading pharmaceutical and medical device companies

Regulatory agencies using ADDPLAN include:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Japan’s Pharmaceuticals & Medical Devices Agency (PMDA)

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)

Over fifty top pharmaceutical, and medical device companies, as well as numerous leading academic researchers are also currently using ADDPLAN.

Video player for Innovation Section

ADDPLAN: Enabling Adaptive Trial Design