India and U.S. companies have complementary strengths from preclinical to Phase II development.

India-based Clinigene and U.S. firm Spaulding Clinical Research are joining forces to offer clinical pharmacology services. Clinigene has a central and bioanalytical laboratory as well as Phase I–IV clinical research facilities. Spaulding Clinical Research has expertise in clinical pharmacology, has a cardiac core lab, and is a medical device manufacturer. 

“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 drug-drug interactions and efficient proof-of-concept, supported by Clinigene’s central and bioanalytical laboratories,” remarks Abhijit Barve, COO of Clinigene. 

Randol Spaulding, CEO of Spaulding Clinical, adds, “With Clinigene’s expertise and cost-effective approach to bioavailability/bioequivalence 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. 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 the complete suite of equipment provisioning and electrocardiogram over-reading services. This includes the Spaulding iQ Electrocardiograph. Both partners have a data solution teams to support clients study data requirements.

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