Reata Pharmaceuticals, Inc. is a privately held company located in Irving, Texas dedicated to researching and developing breakthrough medicines for difficult-to-treat diseases with significant unmet needs. Embarking on a new cardiovascular Phase-II clinical study with multiple study objectives, Reata was challenged with finding a randomization and trial supply management (RTSM) solution that would accommodate the study’s highly adaptive trial design and detailed protocol.
Many of the trial’s characteristics pertaining to patient randomization and drug assignment could not be specified during the study build. Reata wanted to accommodate dosing (escalations, reductions) and cohort size changes during the course of the trial based on accrued in-study data. With this level of complexity, finding the right solution was critical to the success of the trial.
Having extensive eClinical experience, the senior manager of bioinformatics at Reata was not confident that a traditional interactive voice or web response (IVR/ IWR) system could meet their RTSM needs. The study had a level of complexity that prompted Reata to look outside the traditional IVR vendors and solutions that were not sophisticated enough to handle such a complex and evolving study design. The other vendor solutions evaluated were not developed to support an adaptive trial design without expensive and time-consuming programming— neither of which was acceptable to Reata.