Spaulding Clinical Research Quality Management System Achieves ISO 13485 Certification

WEST BEND, Wis., June 21, 2011 /PRNewswire/ -- Spaulding Clinical Research, LLC, leading-edge Clinical Pharmacology, Cardiac Core Lab, and manufacturer of the Spaulding iQSM Electrocardiograph, announced that it has received ISO 13485:2003 Certificate of Registration, one of the first clinical research providers to achieve this certification, issued by BSI effective June 8th, 2011. The certification is a major milestone in Spaulding's 3-year history and confirms Spaulding's commitment to continual improvement, risk management, compliance with statutory and regulatory requirements, and complete customer satisfaction.

"Our integrated Quality Management System (QMS) was designed from the ground up; reflecting the way we work, seamlessly automating study conduct, to deliver high quality results to our pharmaceutical clients.  Study metrics support this level of quality and are used to drive continuous process improvement." stated Paul Schultz, VP of Quality Assurance at Spaulding Clinical.  "With the development of the new Spaulding iQSM Electrocardiograph designed for global clinical trials, it was the right time to move forward with ISO Certification," stated Randol Spaulding, Founder and CEO of Spaulding Clinical.  "Thanks to each and every Spaulding employee for making our QMS the way they work each and every day. This certification is a tribute to Spaulding's continued focus on exceeding customer expectations, and validates our commitment to meeting high quality standards."

ISO 13485:2003 is an internationally recognized quality system standard for the design, development, production, and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective medical devices. As a Clinical Pharmacology, Cardiac Core lab, and medical device manufacturer to the pharmaceutical industry, this third party certification validates our quality commitment, making Spaulding Clinical a valued strategic partner for global pharmaceutical clients.

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.

About Spaulding Clinical

Spaulding Clinical Research, LLC (www.spauldingclinical.com) is a leading-edge Clinical Pharmacology, Cardiac Core Lab and medical device manufacturer 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 as well as a revolutionary new ECG device.

SOURCE Spaulding Clinical Research, LLC