Transforming Randomization and Trial Supply Management

by Stan Haavik, MS, MBA, Director of Product Marketing, Medidata Solutions Worldwide and Feifang Hu, PhD, Professor, Department of Statistics, University of Virginia

This paper introduces Medidata Balance to life science industry managers and executives and compares its use and operation with current randomization and trial supply management (RTSM) methods.

Taking the three stages of a clinical trial—designing the trial, implementing the design and
operating the trial—into consideration, Balance offers a number of advantages over current methods. In designing the trial, Balance offers a distinctively self-service yet robust method when compared to current IVR/IWR systems technology. In the design, Balance provides direct access to the Dynamic Allocation randomization method shown to offer a number of statistical advantages over current block and earlier dynamic schemes. The paper further describes the use of simulation to immediately test the design for balance. Unification with Medidata’s Rave EDC system is obtained with a simple configuration operation connecting Balance and Rave, completing the entire system, now ready for operation. Sites now perform randomization and supplies dispensation and EDC all from one browser, unlike current dual-browser systems which can also require complex data reconciliation processes. The paper concludes by summarizing Balance’s superior design methodology and tools, ease of implementation of the designed system and ease of operation at the site level.

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