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Spaulding Clinical Announces Strategic Partnership with Clinigene International, India for Providing Comprehensive Early Clinical Solutions to Pharmaceutical and Biotech Clients
Date:8/22/2011

quivalence studies, Drug-Drug Interaction and Early Patient Studies.  Spaulding Clinical operates a 105-bed clinical pharmacology unit with 96-beds of Mortara telemetry in West Bend, Wisconsin. The facility is paperless with a phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry.  As a Phase I-IV Cardiac Core Laboratory provider, Spaulding offers the complete suite of equipment provisioning and electrocardiogram over-reading services, including the proprietary Spaulding iQ Electrocardiograph. Both partners have a data solutions team to support clients study data requirements.

Established in 2000, Clinigene (www.clinigeneintl.com) became India's first CAP (College of American Pathologists) accredited Central Laboratory in 2002. Studies conducted at Clinigene's early phase clinic and bioanalytical lab have been inspected by EMEA and US-FDA without Form 483 or critical findings. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

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 I - IV Core ECG Laboratory provider, Spaulding off
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