Clinical Trial Design

Insightful Trial Designer

For innovative clinical trial design, Insightful Trial Designer solution provides intuitive interfaces and easy-to-use workflows for designing, monitoring and simulating flexible clinical trials. The solution will assist you in deploying shorter trials while increasing the probability of their success.

• Point-and-click and S-PLUS® programming interfaces
• Packaged, sequential clinical trial designs
• Custom (e.g. adaptive) designs and outputs
• Validated installation and operation

The Insightful Trial Designer solution is fully integrated with the award winning S-PLUS platform, a validated, industry standard biostatistics programming environment. Our solution allows you to extend your proprietary and standard methods for greater ease of design and testing.

Compute, evaluate and compare clinical trial designs

Reduce Cost and Time of Clinical Trials

• Simulate multiple trials to examine effect on power and type 1 error
• Promote rapid discovery of new beneficial treatments
• Discriminate between relevant scientific hypotheses
• Integrate with your  electronic data capture (EDC) methods

Protect Interests of Patients in Trial

• Stop when credible decision can be made
• Stop if unsafe or unethical

Comprehensive Design and Evaluation Tools

• All commonly used group sequential designs, boundary shapes and scales included
• Comprehensive evaluation tools:
  • Power, conditional power, sample size distribution, inference at the boundaries, and Bayesian analyses
• Flexible Monitoring Methods:
  • Implementation of stopping rules based on error spending functions or constrained boundaries
• Exact p-values, confidence intervals; bias adjusted estimates of treatment effect

Advanced Visualization Tools

• Comprehensive set of specialized plots for study design:
  • Power curves, ASN (average sample size) curves, and stopping probabilities
• Trellis graphics for powerful and effective comparison of designs

Comply with Regulatory Agencies’ Guidelines

• FDA ICH-E9

For more information on Insightful Sequential and Adaptive Trial Design solution, please contact us via email or call in the US/Canada (800) 569-0123, UK +44 (0) 1256 339800, or Basel +41 61 717 9340.