Medidata Solutions Partners with Fast Track Systems to Accelerate Enterprise-Wide Deployments of Electronic Clinical Trials.

Integration of Medidata Rave and Fast Track TrialSpace Designer Improves Efficiency in Clinical Study Deployment from Protocol Design to EDC Study Build

NEW YORK -- Medidata Solutions, a global provider of electronic clinical data capture, management and reporting solutions, today announced its partnership with Fast Track Systems, Inc., a provider of clinical trial design software and professional services. The companies have entered into a multi-year agreement to integrate Fast Track's TrialSpace Designer[R] (TSD) study design software with Medidata Rave[R], the industry leading EDC platform.

Traditionally, study design and EDC study build have been thought of as separate activities. Sponsors have prepared protocols and statistical plans using simple desktop applications that lack the intelligence to identify potential inconsistencies throughout these lengthy documents. In addition, EDC roll outs have required significant implementation and validation activities for each study. The combination of TrialSpace Designer and Medidata Rave integrates these two previously separate activities and creates a seamless flow of information from initial study design through electronic case report form (eCRF) build and beyond.

Customers leveraging the combined solution can optimize their clinical development practices through Fast Track's easy-to-use design tool to seamlessly create both study documents and standards-based study data models. Expanding on Rave's existing capabilities around rapid study build and deployment, this partnership allows automatic implementations of CRFs and workflow for studies based on electronic study design standards.

"As the industry struggles to contain rising development costs, the combined solution of TrialSpace Designer and Rave will reduce costly inefficiencies and expand execution capacity by automating many complicated study start-up processes," said Ed Seguine, CEO of Fast Track Systems, Inc. "The capability of TSD to initially capture and model complex trial design information perfectly complements Rave's ability to efficiently configure and manage this data throughout the execution lifecycle. The vision of a truly integrated study design and execution suite is indeed a reality."

With this partnership, sponsors will be able to use TSD to define a clinical trial protocol, statistical plan and operational details, then export the information according to the CDISC operational data model standard. From there, the exported data can be used to set up an EDC-based trial using Medidata Rave's Architect Loader, an XML-based study build tool.

"Fast Track's break-through protocol authoring and study design technology integrated with Rave will allow us to deliver our customers an optimal solution for executing clinical trial operations from study design through data capture and clinical data management," said Glen de Vries, CTO of Medidata Solutions. "We've already achieved a 50 percent reduction in study configuration requirements, and with our continued work together combined with rapid reusability offered by Rave's Global Library, we expect to reduce the workload for study deployment even further."

About Fast Track Systems, Inc.

Fast Track's products reduce cost, increase compliance, and improve productivity by solving problems associated with the operational aspects of clinical trial design and execution. TrialSpace Designer ensures greater consistency and transparency in trial design by capturing study design information as reusable data that can be utilized by other clinical systems and leveraged for related purposes. Grants Manager and CROCAS draw from over 25,000 finalized protocols, 240,000 negotiated grants, and 4,000 CRO contracts to ensure that subscribers understand the true cost and compliance consequences when negotiating clinical agreements. Visit www.fast-track.com for more information about our products and services.

About Medidata Solutions Worldwide

Medidata Solutions helps the world's leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data - the lifeblood of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market - on six continents and in more than 80 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com.