Biocon clinical arm, Spaulding of US in clinical trial partnership

Clinigene International Ltd, the clinical research arm of Indian biotech major Biocon Ltd, has entered into a partnership with Spaulding Clinical Research, LLC of the United States for providing early clinical solutions to pharma and biotech clients.

Clinigene International, an India-based central and bioanalytical laboratory, undertakes Phase I to IV clinical research while Spaulding, based in the US, is a leading-edge clinical pharmacology, cardiac core lab, and medical device manufacturer.

"This partnership establishes a reliable, trustworthy, and cost-efficient global footprint for clinical pharmacology services, providing an opportunity for both organisations to engage pharmaceutical clients strategically and accelerate first-in-human to proof-of-concept clinical development," the two companies said in a joint statement.
"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," Dr Abhijit Barve, chief operating officer of Clinigene, said.

"The strengths of both companies are very complementary with Clinigene providing the preclinical development (through sister-company Syngene), Spaulding providing first-in-human (FIH) / single ascending dose (SAD) / multiple ascending dose (MAD), and Clinigene providing data documentation initiative (DDI) and efficient proof-of-concept, supported by Clinigene's central and bioanalytical laboratories. With Clinigene's expertise and cost-effective approach to bioavailability (BA)/ bioequivalent (BE) and Spaulding's market-leading TQT study and cardiac core lab expertise, our clients are able to easily structure a programme for their compound that delivers high-value while keeping the molecule knowledge experts involved throughout the entire early clinical development of the compound," stated Randol Spaulding, CEO of Spaulding Clinical.

Clinigene operates a central laboratory accredited by the College of American Pathologists (CAP) 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.

Clinigene has expertise in bioavailability/bioequivalence studies, drug-drug Interaction and early patient studies.