Medidata Solutions Broadens the Capabilities of Its Cloud-based Randomization and Trial Supply Management Solution

Medidata Balance Now Offers Multiple Randomization Methodologies to Further Drive Efficiencies and Reduce Costs of Study Start-up

Medidata Solutions (NASDAQ: MDSO) announced today a major new release of Medidata Balance ™, a randomization and trial supply management (RTSM) application which is part of Medidata’s comprehensive clinical cloud platform. Balance now provides the popular block randomization methodology in addition to the powerful and flexible dynamic allocation methodology it previously offered. These two methodologies cover the large majority of the range of developers’ requirements for randomly allocated clinical trials.

Sponsors use randomization technology to assign newly enrolled patients to a treatment group. Appropriate randomization methodology is critical to ensuring statistical validity and can also affect the required number of enrolled patients. Drug development teams now have the flexibility to choose the most frequently used randomization methodologies while leveraging the key features of the cloud-based Balance, including guided user setup and simulation capabilities, and built-in integration with the Medidata Rave ® system for electronic data capture (EDC) and clinical data management (CDM).

• “We designed Balance to address one of the key activities in the clinical trial process that we knew could be supported with more efficient, faster and more intelligent tools,” said Glen de Vries, president of Medidata Solutions. “With the broader capabilities in Balance’s new version, sponsors and CROs can now choose either permuted block or dynamic allocation randomization, within our low-risk, easy-to-deploy and easy-to-use cloud-based randomization solution.”

With intuitive, configurable capabilities for designing the randomization plan, Balance offers sponsors built-in simulation to test the quality of the balance achieved across the sites, strata and factors, as well as the entire study. With Balance’s new permuted block capability, the simulator can also be used to compare randomization results of dynamic allocation against block, offering sponsors a new level of visibility in trial planning.

Once the design for the study is complete and trial operations have begun, all randomization and treatment dispensation instructions are sent to investigative site staff through the Medidata Rave platform using a single browser interface. With Balance, site staff can access one integrated, easy-to-use system to enroll subjects in treatment arms, receive treatment instructions and capture patient data.

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About Medidata Solutions Worldwide

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

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