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West Bend, WI, November 2, 2009 - Spaulding Clinical Research, a newly designed Phase I
Unit provisioned for all types of pharmaceutical trials including the most complex cardiac
safety studies, announces the recent completion of an 11-week, 240 subject thorough QT
study (TQT). Results were available for 99.63% of the total 17,280 ECGs required for the
study in real time throughout the study, and there was no ECG data loss, 99.85% of pre-
scheduled ECGs being successfully captured with high quality.
Spaulding Clinical has integrated the newest technology to automate the collection and
storage of virtually all data in a way the industry has not seen before. Paper records and
manual data entry have been virtually eliminated which; also eliminates human errors and
data loss. As a result the Spaulding Clinical staff spends more time in direct care of the
subjects.
The integration of modern technology and the resulting availability of most data in real-time
allows earlier identification of adverse events and earlier delivery of high quality data to the
Sponsor.
One of Spaulding Clinical’s innovations is the electronic integration of multiple data sources
with the ALPHADAS (Logos Technologies’ clinical trial platform). Tanna Kreigh, from
Logos, who has over 30 years of clinical trial experience, said, “I am amazed at how
thoroughly Spaulding Clinical staff has integrated data sources with our ALPHADAS
platform. In other phase I units I’ve observed near chaos on study days. However the staff at
Spaulding Clinical are incredibly confident and very efficient in their work. Things were so
well organized and executed I would never have known that it was a study day until I looked
at the monitors to see data coming in.”
Spaulding Clinical has now successfully recruited large numbers of study subjects and
quickly and efficiently completed several TQT studies and less complex pharmacokinetic
studies.
About Spaulding Clinical
Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) is a
Phase 1 Clinical Research Unit and Cardiac Core Lab, offering a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, and PK/PD characterization. Spaulding Clinical also offers a full suite of Cardiac Core Lab and over-reading services with state-of-the-art technology and cardiac expertise.
Contact:
Spaulding Clinical
Amanda Baltz
262.306.3324
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