Clinigene International, India-based clinical research organization belonging to Biocon Ltd, and Spaulding Clinical Research LLC., a leading-edge clinical pharmacology, cardiac core lab, and medical device manufacturer, have entered into a strategic partnership agreement for providing clinical pharmacology services to pharmaceutical clients. This partnership will provide an opportunity for both organizations to engage pharmaceutical clients strategically and accelerate first-in-Human to proof-of-concept clinical development. Both partners have a data solutions team to support clients study data requirements.

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. 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.

Dr Abhijit Barvebarve, COO of Clinigene, said, “Pharmaceutical clients globally are increasingly seeking strategies to expedite their early clinical development, streamlining processes while maintaining high quality. Our strategic partnership is designed to deliver this in a very cost-effective manner.”

Randol Spaulding, CEO of Spaulding Clinical, said, “The strengths of both companies are very complementary with Clinigene providing the preclinical development (through sister concern Syngene), Spaulding providing FIH/SAD/MAD, and Clinigene providing DDI and efficient proof-of-concept, supported by Clinigene's central and bioanalytical laboratories”.