Medidata Solutions Introduces Unified Platform for Randomization, Trial Supply Management and Data Capture
Medidata Balance and Medidata Rave Replace Costly, Complicated IVRS Development and
EDC Integration with a Unified Solution for Fast Study Start-up and Simplicity at Sites
NEW YORK, N.Y. - June 14, 2010 - Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today introduced Medidata BalanceTM, 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 much 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, easy-to-use 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). These help our customers attack inefficiencies head-on and continue to evolve and improve the clinical trial process."
Medidata will be demonstrating Balance in its booth #1517 at the Drug Information Association (DIA) Annual Meeting, held June 13-17, 2010 in Washington, D.C.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers' clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata's advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidataTM), randomization and trial supply management (Medidata BalanceTM), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse 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.