Spaulding Clinical Presenting as Finalist in Data Driven Award

Spaulding Clinical Presenting ECG Integration Tool as Finalist in Data Driven Innovation Award at SCDM Meeting

SCi ECG Offers Automatic Transfers of Spaulding Clinical ECG data into AlphaDAS EDC/CDM System

Minneapolis, MN – October 17, 2010 – Leading-edge Clinical Pharmacology and Cardiac Core Lab provider Spaulding Clinical Research will be presenting its proprietary ECG Integration Tool at the Society for Clinical Data Management today. Spaulding Clinical was selected as one of five finalists considered for the Data Driven Innovation Award.

Spaulding Clinical created an application named SCi ECG which bridges the data gap between a proprietary EDC system (Logos Technologies AlphaDAS) and an ECG technology suite (Mortara Surveyor/E Scribe). The application manages data flow from study setup to database lock, allowing Sponsors to access ECG data in a near real-time fashion. Subject demographics and ECG scheduled time-points from the Sponsor’s protocol propagate directly from the EDC system to the ECG systems. The ECG system is aware of the subject data and the exact timing for ECGs. Data is never duplicated. SCi ECG allows Sponsors to see two types of ECGs in real time: unconfirmed ECGs; and, cardiologist measured and interpreted ECGs.    Also, SCi ECG can optionally integrate with IP camera systems to provide objective evidence of positional ECGs.

Brock Heinz, Systems Integration Engineer at Spaulding Clinical, developed SCi ECG and said: “SCi ECG is an innovative example of clinical interface design. From a technical perspective, the system bridges two well- respected clinical data systems by leveraging industry data standards and interoperability best practices. The system empowers Spaulding Clinical to use these best-of-breed systems in ways that maximize their benefits when acquiring ECG data in clinical trials. It is very rewarding to see others as excited about this technology as we are.”

The SCi ECG integration gives Data Managers confidence that ECG data will be of highest quality with continuous ECG monitoring, as well as automatic ECG extractions. Deviations are nearly eliminated in this environment. With this model, Sponsors see a single unified view of all of the Phase I study data being collected in nearly real time, which allows them to make decisions about future cohorts.

“At Spaulding, our main focus with data lies in prevention: prevention of errors, unnecessary hand-offs and, ultimately, prevention of queries. This system generates an incredible amount of time savings and, therefore, cost savings to Sponsors,” said Daniel Selness, VP of Clinical Operations at Spaulding Clinical.

SCDM created the Data Driven Innovation Award program in 2007 to recognize important vendor and sponsor relationships and to build awareness of a new product or service in the CDM field. The program recognizes the year’s best advancement in CDM, and awards innovation that improves technology or processes within clinical research studies.

Spaulding Clinical is demonstrating SCi ECG at Booth 618 from October 17 – 19 at the SCDM meeting in Minneapolis, MN. Spaulding Clinical will present SCi ECG for the Data Driven Innovation Award at 10:30 on Monday, October 18th at the Spaulding Clinical booth.

About Spaulding Clinical
Spaulding Clinical (www.spauldingclinical.com) is a Phase I Clinical Research Unit and Electrocardiography Core Lab located in West Bend, Wisconsin offering a full range of services including TQT studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect studies, PK/PD characterization, and data collection and management. Spaulding Clinical also offers a full suite of Electrocardiography Core Lab and over-reading services with state of-the- art technology and cardiac expertise.

Spaulding Clinical Contact:
Amanda Baltz Sr. Director, Business Operations and Development

+1.262.306.3324

[email protected]