Gil Roth08.22.11
Clinigene International Ltd., an India-based central and bioanalytical laboratory and Phase I -IV CRO , has established a strategic partnership with Spaulding Clinical Research, LLC, a U.S.-based clinical Pharmacology , cardiac core lab, and medical device manufacturer. According to a joint statement, "This partnership establishes a reliable, trustworthy, 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."
Randol Spaulding, chief executive officer of Spaulding Clinical, remarked, "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 expertise and cost-effective approach to BA/BE 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, India, focusing on 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, 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 equipment provisioning and electrocardiogram over-reading services, including its proprietary Spaulding IQ Electrocardiograph.
Randol Spaulding, chief executive officer of Spaulding Clinical, remarked, "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 expertise and cost-effective approach to BA/BE 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, India, focusing on 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, 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 equipment provisioning and electrocardiogram over-reading services, including its proprietary Spaulding IQ Electrocardiograph.
