Norwich Expands Capabilities for Phase I-III Clinical Trials
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Norwich Clinical Services (NCS) has announced a significant expansion to its clinical research capabilities in order to meet growing market demand.
Primary to the expansion, NCS unveiled a new clinical facility with capabilities to conduct all aspects of Phase I - III clinical trials including pharmacokinetics in healthy volunteers, bio-availability and bio-equivalence 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," stated Dr. Saral Thangam, MD, PhD, managing director of Norwich Clinical Services.
Dr. Thangam continued, "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 square foot 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.
In conjunction with this new facility opening, Norwich Clinical Services is also conducting additional clinical programs within a separate FDA and EMA-approved research facility.
Studies conducted at this 86-bed facility have been submitted to prominent 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 Norwich Clinical Services.
Novak continued, "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."
