West Bend, WI – June 20, 2011 – Leading-edge Clinical Pharmacology, Cardiac Core Lab provider, and medical device manufacturer Spaulding Clinical Research, LLC, 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 real time, or at any defined interval during the normal flow of study conduct, providing sponsors with the latest information at all times. “This allows sponsors immediate access to data for interim analysis during the course of the study, but more importantly, study queries can be initiated and resolved in real time, not weeks or months after the study is complete,” stated Daniel Selness, General Manager and Senior Vice President of Operations for Spaulding Clinical.
“Spaulding Clinical has been an active Medidata Technology Partner for the past year and we are delighted to see them pioneer this integration initiative, as many of our clients have been asking for this solution to drive efficiencies in Phase I research,” states Anne Zielinski, Vice President of Alliances for Medidata Solutions. “The automated integration of clinical pharmacology study data makes data available sooner and enables better decision-making as clients determine which drug candidates to progress."
“Our vision from the start of Spaulding Clinical is to create a world-class clinical research facility that transforms clinical studies through the use of technology supporting expert clinical researchers,” stated Randol Spaulding, Founder and CEO. “This is only one example of how Spaulding is transforming clinical research, providing both time and cost advantages for our clients.” Spaulding Clinical will be demonstrating their cutting-edge clinical pharmacology and data solutions as well as the new Spaulding Electrocardiograph and Core ECG Lab Solutions in booth 1905 at the DIA Annual Meeting taking place June 19 – 22, 2011, Chicago, IL.”
About Spaulding Clinical
Spaulding Clinical Research, LLC (www.spauldingclinical.com) is a Clinical Pharmacology Research Unit and Cardiac Core Lab that offers a full range of global services from study design through study execution/conduct, data management, statistical analysis, and clinical summary/expert reporting. Spaulding has extensive experience conducting TQT, first-in-human, multiple rising dose, bioavailability/bioequivalence, drug interaction, and food effect studies. As a Phase 1-4 Core Lab provider, Spaulding offers the complete suite of equipment provisioning and electrocardiogram over-reading services with state-of-the-art technologies and expertly trained cardiologists.