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Spaulding, Clinigene in Early-Phase Partnership

U.S., Indian companies join forces in clinical pharmacology

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Clinigene International Ltd., an India-based central and bioanalytical laboratory and Phase I-IV CRO, has established a strategic partnership with Spaulding Clinical Research, LLC, a U.S.-based clinical pharmacology, cardiac core lab, and medical device manufacturer. According to a joint statement, “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.”

Randol Spaulding, chief executive officer of Spaulding Clinical, remarked, “The strengths of both companies are very complementary, with Clinigene providing the preclinical development (through sister-company Syngene), Spaulding providing FIH/SAD/MAD, and Clinigene providing DDI and efficient Proof-of-Concept, supported by Clinigene’s central and bioanalytical Laboratories. With Clinigene’s expertise and cost-effective approach to BA/BE and Spaulding’s market-leading TQT study and Cardiac Core Lab expertise, our clients are able to easily structure a program for their compound that delivers high-value while keeping the molecule knowledge experts involved throughout the entire early clinical development of the compound.”

Clinigene operates a CAP-accredited central laboratory and GLP-compliant bioanalytical laboratory for small and large molecules, as well as a 94-bed clinical pharmacology unit in Bangalore, India, focusing on bioavailability/bioequivalence 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, WI. 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 equipment provisioning and electrocardiogram over-reading services, including its proprietary Spaulding iQ Electrocardiograph.

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