PRESS RELEASE


April 2008

Medidata Solutions, a global provider of clinical trial technology, announced that Medidata Designer™ was selected by Bio-IT World Magazine as a finalist for the Best of Show award in the Clinical Trials and Research category. Winners will be announced at the Bio-IT World Conference + Expo, held April 28-30, 2008 at the World Trade Center in Boston.

Cambridge Healthtech Institute’s Bio-IT World is a premier B-to-B publication addressing the technologies driving discovery, development and clinical trials. Judged by a team of Bio-IT World magazine editors and leading industry experts, the Best of Show awards program spotlights new products that demonstrate exceptional technology innovation across the life sciences research, discovery and clinical trials process. Winners are chosen among entries submitted from leading bio-IT vendors exhibiting at the annual conference and expo, based on the products’ technical merit, functionality and innovation.

Medidata Designer is an electronic protocol authoring tool that captures both the textual description of a study as well as a structured, electronic model of the trial specifications that can be leveraged downstream in clinical and operational study management and design. It was built to bring better quality, consistency and control to the protocol authoring process and deliver tangible benefits to medical writers, clinicians and statisticians who author the protocol and other associated study documents. Furthermore, Medidata Designer can automatically configure other clinical trial systems – such as electronic data capture (EDC), clinical trial management (CTMS), electronic patient reported outcomes (ePRO), data analysis and electronic data submissions –
ensuring an automated environment for consistent, shared clinical and operational requirements. As an example, while most study-build tools facilitate EDC set-up based on a paper copy of the study protocol after it has been written, Medidata Designer can take advantage of work already being done much earlier in the protocol writing process to electronically inform the EDC system, potentially reducing set up times and costs significantly. Medidata Designer:

Deploys a standardized protocol development methodology that assures quality consistency and continuity of trial protocols to more effectively execute the clinical plan;

Includes an extensive set of automated quality checks that can significantly reduce the number of ambiguities, omissions and errors in a protocol document;

Retains organizational knowledge and builds company standards by populating a protocol warehouse with consistent study design parameters; and

Facilitates compliance with CDISC SDTM data submission standards with the only CDISC-certified protocol authoring tool.

“The selection of Medidata Designer as a finalist in the Bio-IT World Best of Show awards further reinforces that electronic protocol design is emerging as one of the more significant areas that holds the promise of time savings and efficiency gains for research sponsors,” said Ed Seguine, General Manager of Trial Planning Solutions at Medidata Solutions. “We are proud to
join other leading clinical technology companies in the Clinical Trials and Research category and look forward to showcasing Medidata Designer at next week’s conference.”


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