Clinigene International, a subsidiary of Biocon Ltd, has entered into a strategic partnership with US-based Spaulding Clinical Research for providing comprehensive early clinical solutions to pharmaceutical and biotech clients.

According to Dr Abhijit Barve, chief operating officer of Clinigene, “The 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.”

Spaulding Clinical Research has expertise in clinical pharmacology, cardiac core lab, and medical device manufacturer. Spaulding Clinical also operates a 105-bed clinical pharmacology unit with 96-beds of Mortara telemetry in West Bend, Wisconsin.

“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,” explained Dr Barve.

The strengths of both companies are very complementary with Clinigene providing the preclinical development (through sister concern Syngene), Spaulding providing F1H/SAD/MAD, and Clinigene providing DD1 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 TOT study 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,” states Mr Randol Spaulding, CEO of Spaulding Clinical.

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