Medidata Solutions, a global provider of SaaS-based clinical development solutions, introduced Medidata Balance, a new randomization and trial supply management (RTSM) solution for clinical research sponsors and sites. Balance’s web-based technology, unified with the Medidata Rave electronic data capture (EDC) and clinical data management (CDM) platform, and its simplified approach to dynamic randomization enable study teams to greatly reduce trial planning and implementation time, effort and costs and potentially reduce the number of subjects required to be enrolled. .
An extremely critical part of the planning and execution of many trials—the design, implementation and conduct of a randomization plan to allocate patients to different treatment arms—can be a very complicated and time-consuming process. Randomization planning typically involves specification with spreadsheets, various computational methods and much iteration among functional groups, followed by a complex and lengthy software development project for the use of a telephone-based interactive voice-prompted response system (IVRS)—which often takes months to develop and test. The IVRS is used by clinical sites to enroll patients and allocate treatments, in addition to a separate EDC system used to collect often redundant patient data as well as clinical results. Attempts at reducing this redundancy by integrating the IVRS and EDC systems add complexity and time to the project, especially when the systems are provided by different vendors. .
Medidata Balance offers life sciences companies a higher level of efficiency and effectiveness in trial design and operation, eliminating the need for programming, separate tools or spreadsheets. Balance brings all elements of the design and execution of randomization and supply logistics into one web-based solution: .
-A straightforward browser interface guides the creation of the randomization design; -A powerful dynamic allocation algorithm creates the assignments to arms and strata; -An integrated simulation tool tests the assignments and confirms the desired level of balance. .
Once designed, all randomization and supply logistics information is immediately accessible by site staff via the Medidata Rave platform and browser interface in electronic case report forms (eCRF). As a result, enrolling subjects to different treatment arms, receiving treatment instructions and capturing and reporting clinical results during visits all take place in one system. .
“While IVRS and their newer web-based variants have played a key role in clinical research over the past several years, randomization and supply management offerings remain consistently service-heavy and custom-tailored,” said Glen de Vries, president of Medidata Solutions. “With Medidata Balance, we’re bringing to RTSM the same values that Medidata Rave brought to EDC—simple interfaces to configure complex behavior, short time-to-value, low total cost of ownership and truly scalable software-as-a-service (SaaS).” .