Protocol Development

Protocol Development

Making sure that the statistical foundation of your clinical trial is solid ensures the integrity of your trial, as well as helps reduce cost and accelerate results.

For this reason, pharmaceutical and medical device companies rely on ARA for assistance with the statistical sections of the protocol. We provide strategic statistical inputs for protocol design including:

  • endpoint specifications
  • sample size determination
  • randomization plans
  • statistical analysis plans
  • interim analysis
  • stopping rules

Study Randomization

Proper study randomization is the foundation that permits the use of probability in analyzing results. That’s why at ARA, we work with sponsors to select a procedure—whether it be simple, stratified, restricted, or adaptive—to ensure the integrity of the trial results.