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Clinigene International Limited and Spaulding Clinical Research, LLC announced a strategic partnership agreement. This partnership establishes a reliable 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.
"Pharmaceutical clients globally are increasingly seeking strategies to expedite their early clinical development. Its strategic partnership is designed to deliver this in a very cost-effective manner," states Dr. Abhijit Barve, Chief Operating Officer of Clinigene. "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 cost-effective approach to BA/BE and Spaulding's TQT study and Cardiac Core Lab expertise, our clients are able to 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," states Randol Spaulding, CEO of Spaulding Clinical.
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. 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.