Biocon’s subsidiary enters into a strategic partnership with Spaulding Clinical Research

22 Aug 2011 Evaluate

Clinigene International, a subsidiary of Biocon and Spaulding Clinical Research, LLC, US-based leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, have entered into a strategic partnership agreement. This partnership establishes a reliable, trustworthy, and cost-efficient global footprint for clinical pharmacology services providing an opportunity for both organizations to engage pharmaceutical clients strategically and accelerate First-In-Human to Proof-of-Concept clinical development.

The strengths of both companies are very complementary with Clinigene providing the preclinical development (through sister concern Syngene), Spaulding providing F1H/SAD/MAD, and Clinigene providing DD1 and efficient Proof-of-Concept, supported by Clinigene's Central and Bioanalytical Laboratories.

Clinigene operates a CAP-accredited Central Laboratory and GLP-compliant Bioanalytical Laboratory for small and large molecules, both equipped with state-of-art technology, as well as a 94-bed clinical pharmacology unit in Bangalore, India which excels at Bioavailability/Bioequivalence studies, Drug-Drug Interaction and Early Patient Studies. While 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 1 Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core Laboratory provider, Spaulding offers the complete suite of equipment provisioning and electrocardiogram over-reading services, including the proprietary Spaulding iQ Electrocardiograph. Further, both partners have a data solutions team to support clients study data requirements.

Clinigene International which is a subsidiary of Biocon is an Indian-based Clinical Research Organization with Phase I-IV clinical research and extensive Bioanalytical capabilities

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