FOR IMMEDIATE RELEASE
Cutting-edge CDISC ODM-certified Clinical Protocol Authoring and Trial Design Tool
to be Showcased at Upcoming Bio-IT World Conference & Expo
NEW YORK, N.Y. – April 24, 2008 – Medidata Solutions, a global provider of clinical trial technology, today 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 ownstream 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.”
Medidata Solutions will be exhibiting at booth #100 at the Bio-IT World Conference + Expo. For more information, visit www.bio-itworldexpo.com.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading provider of clinical trial solutions that enable the world’s most advanced life science organizations to maximize the value of their clinical research investments by putting powerful tools into researchers’ hands. A pioneer since 1999 in innovative technologies for planning and managing clinical studies – including protocol design; clinical data capture, management and reporting; and trial contracting and negotiation – Medidata Solutions and its global network of business partners address the unique needs of sponsors and sites of all sizes. With deep expertise in conducting studies across all phases and therapeutic areas, on six continents and in more than 80 countries, Medidata Solutions helps clinical researchers reduce trial cycle times, achieve early visibility to reliable clinical data, and maintain strict fiscal responsibility, while safely accelerating the process of bringing lifeenhancing treatments to market.
Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com