Transforming Randomization and Supply Management
in Clinical Trials
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. Thanks to simple and fast unification of Balance with the Medidata Rave®
system for electronic data capture (EDC) and clinical data management (CDM), sites use just one browser interface—Medidata Rave—for randomizing subjects, supply dispensation and clinical data entry and reporting.
A Choice of Block or Dynamic Allocation Randomization
With its self-service interface, Balance enables the creation of randomization designs across the study, sites, factors and cross-factor strata with ease. With the availability of permuted block and dynamic allocation randomization methods, researchers can use the approach that best suits their study goals. With either method, the study designer chooses the arms, factors and strata that define the selection and allocation of subjects. This is done simply by entering information in the easy-to-use browser form. As another unique and powerful feature, randomization can be immediately tested with a built-in simulation capability. With each simulation run representing one complete trial, the results display the actual balance achieved and statistical measures of variation to the sponsor. Researchers can then adjust the design of the study to minimize bias in accordance with study goals.
Supply Planning and Dispensation
The supply plan is also created using an intuitive web-browser interface, prompting the user to specify initial inventory at sites, thresholds for reordering and reorder 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. Predictive or buffer-based algorithms make use of long or short window techniques to achieve optimum supply management. Within Medidata Rave’s interface at the site, clinicians receive and enter information concerning dispensation and usage, creating a feedback loop that drives the replenishment cycle.
Fast Design Implementation
Unlike current RTSM methods with interactive voice response and interactive web response (IVR/IWR) systems—which can require weeks of effort for programming, testing and training—Balance is immediately accessible after the entry of parameters that define the study and is then quickly integrated within Medidata Rave. The system is ready for use by sites and the study trial is in operation in a matter of days—a major paradigm shift for randomization.
Easy to Use for Investigative Sites
With Balance, investigators interact with only one system for EDC, randomization and supply management. Gone are cumbersome phone-based methods for randomization and multiple interfaces for sites’ data entry. Sites now receive patient instructions on electronic case report forms (eCRFs) in Rave, and the site enjoys unprecedented simplicity and accuracy of operation.