Case Study: Reata Pharmaceuticals achieves multimillion-dollar savings and faster adaptive trial setup with Medidata Solutions' Balance

Reata Saves Millions Leveraging the Adaptive Functionality of Medidata Balance

Reata Pharmaceuticals, a privately held biopharmaceutical company in Irving, Texas, faced a complex cardiovascular Phase II trial with multiple objectives, adaptive dosing and cohort changes, and requirements that could not be fully specified at study start. Traditional IVR/IWR vendors lacked the flexibility to support in-study dose escalations, arm drops and rapid protocol changes without costly, time-consuming programming, so Reata needed an RTSM that supported real-time adaptations while maintaining the study blind.

Reata implemented Medidata Balance, a cloud-based, fully configurable RTSM unified with Medidata Rave, enabling rule-based dosing, titration and mid-study changes without vendor intervention. The system was configured in two days, allowed Reata to collapse three planned studies into one (saving millions), reduced titration rules from 1,152 to 88, and lowered operational risk and timeline through integrated, agile supply and randomization management.

Reata Pharmaceuticals

Arthur Gibson

AVP of Bioinformatics