Norwich Expands Clinical Capabilities

Norwich Clinical Services (NCS) is expanding its clinical research capabilities with a new clinical facility in Bangalore, India to conduct all aspects of Phase I-III trials including pharmacokinetics in healthy volunteers, bioavailability and bioequivalence studies, drug metabolism studies, dose proportionality studies and multiple dose studies.
 
“Utilizing proven technologies and this new, modern clinical facility, NCS is now able to offer functional expertise and therapeutic experience with reliability that will create cost and time efficiency for customers,” said Dr. Saral Thangam, M.D., Ph.D., managing director of Norwich Clinical Services. “We are proud to be opening this new clinical trial facility with full regulatory approval from the Drugs Controller General of India as an indication of our unequivocal adherence to GCP, GLP, CFR part 11 and other applicable regulatory requirements.”
 
The 72-bed, 16,500-sq.-ft. facility has been successfully audited by the Drugs Controller General of India and contains separate areas for subject screening and blood draws, an on-site pharmacy, and a fully equipped intensive care unit. NCS is also conducting additional clinical programs in a separate FDA- and EMA-approved research facility. Studies conducted at this 86-bed facility have been submitted to health agencies including FDA, EMA, TPD, MHRA and DCGI.
 
“Our customers’ needs are rapidly evolving for contract pharmaceutical services and we understand that Norwich capabilities must also evolve to include one comprehensive solution for all stages of the product lifecycle,” said Terry Novak, president of Norwich Pharmaceuticals, the parent company for NCS. “Combining the clinical trial capabilities of these two research facilities will meet a specific need for Norwich customers seeking budget efficiency and schedule adherence from the early stages of development through study-end reconciliation.”