Spaulding Clinical Research, LLC: Spaulding Clinical to Showcase Customer's Fully Automated Phase I Clinical Data Integration with Medidata Rave at DIA

June 20, 2011

Spaulding Clinical Research announced the successful integration and electronic transfer of study data from Spaulding's clinical trial management system (CTMS) to the Medidata Rave electronic data capture (EDC) and clinical data management (CDM) system for a major global pharmaceutical client conducting a Phase I endocrinology indication.

Last June, Spaulding Clinical was recognized by Medidata Solutions as a Medidata Technology Partner after leveraging Medidata Web Services application programming interfaces (APIs) to enable data collected in Spaulding's Phase I unit, including clinical conduct, laboratory, vital signs and ECG data to be automatically transferred into Medidata Rave. Spaulding pioneered the full integration of Medidata Rave Phase I study data demonstrating the efficiency gained from using EDC in a clinical pharmacology environment. The integration enables the rapid transfer of all clinical pharmacology data, including ECG data, into Medidata Rave. Sponsors benefit from Rave data management capabilities for Phase I trials and the ability to more easily view clinical data from all trial phases in Rave.

"The use of the interface on this TQT study delivered flawless data, removed human error, and demonstrated significant cost and time savings," stated Brock Heinz, Vice President of Engineering for Spaulding Clinical.

Using the traditional industry model, manual transcription of the study from the Phase I EDC system delayed study completion by six weeks, increased cost by more than $25,000, and introduced hundreds of transcription errors. In the Spaulding Clinical model, electronic data transfer is completed error-free within minutes of approval to transfer, thus shaving weeks from study timelines.

All study data can be transferred in realtime, or at any defined interval during the normal flow of study conduct, providing sponsors with the latest information at all times.

Spaulding Clinical will be demonstrating their cutting-edge clinical pharmacology and data solutions as well as the new Spaulding iQSM Electrocardiograph and Core ECG Lab Solutions in booth 1905 at the DIA Annual Meeting taking place June 19 – 22, 2011, Chicago, IL.

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