Transforming Randomization and Supply Management
in Clinical Trials

Medidata Balance™ provides a unique and unified approach to randomization and trial supply management (RTSM) in clinical trials. While RTSM has long been characterized as a lengthy and expensive process, Medidata Balance transforms it into a self-service operation of randomization and supply planning, simple and fast unification with Medidata Rave^® EDC and ease of operation at sites. With Medidata Balance, sites use just one browser interface for randomizing subjects, supply dispensation and clinical data entry and reporting.

Powerful Yet Simple Randomization

With its self-service interface, Balance easily enables the creation of randomization designs across the study, sites, factors and cross-factor strata. Using a powerful Dynamic Allocation algorithm, better balance is achieved than with block methods or with other dynamic methods. As selections are made to arms, Balance continually adjusts its next selections to assure a continued balance is maintained. Further, to ensure that predictability does not influence the selection of subjects, Balance employs a “Second Best Factor” so that the allocation method continues to be masked throughout the trial. As another unique feature, the randomization can be immediately tested with a built-in simulation capability. With each simulation run representing one complete trial, the results show the sponsor the actual balance achieved and statistical measures of variation.

Supply Planning and Dispensation

The supply plan is also created using a web-browser interface, prompting the user to specify initial inventory at sites, thresholds for re-ordering and re-order quantities. Shippers and other participants in the supply process receive messages from Balance alerting them to requirements for supplies, and reporting keeps the sponsor aware of all supply activities. Via the unified interface at the site, clinicians receive and enter information concerning dispensation.

Fast Design Implementation

Unlike current methods with interactive voice response and interactive web response (IVR/IWR) systems, in which weeks of effort are involved in programming, testing and training, Balance is quickly integrated with the Rave EDC system. This is a major paradigm shift for RTSM. In only a few days or less, the system is ready for use by sites and the trial is in operation.

Easy to Use for Investigative Sites

Investigators now interact with just one system that combines EDC, randomization and supply management. Gone are cumbersome phone-based methods for randomization and multiple interfaces for data entry. Site instructions are now delivered on electronic case report forms (eCRFs) in Rave; the site now enjoys unprecedented simplicity and accuracy of operation.