Founded by Jonathan R. Smith, Ph.D. in 2007 to help sponsors, where possible, achieve one or more of the following:

• Decrease Cost of a Trial or Program, and/or Shorten the expected Duration of a Trial

• Cut expected Time to NDA Submission

• Increase the Chance that Phase III Trial will be Positive for Efficacy and so Decrease Late-Stage Attrition

• Increase the Chance that Phase II Trial(s) Identify Most Appropriate Dose(s) to Take Into Phase III

• Increase the Chance that Program Identifies any Subpopulation(s) where Drug Benefit-Risk is Much Greater

• Increase expected Net Present Value for the Compound

Makes use of techniques such as the following to achieve these Gains:

• Adaptive Trial Designs of many different types

• Group-Sequential Designs, incorporating Early Efficacy Looks for Success and/or Futility

• Predictive Biomarker Development

• Simulation of the Clinical Trial under multiple scenarios

• Other Innovative Design approaches at the Trial or Program Level

• Many types of Modeling, including Dose-Response Modeling

• Improved Analysis, particularly for dealing with Regulatory Requirements re Multiplicity