KMC Manipal AcuNova, a clinical research organisation (CRO), has commissioned its clinical research centre at Manipal today.
The facility has come up at a cost of Rs 7 crore and will primarily focus on Bioavailability and Bio-equivalence (BA/BE) studies performed for generic drugs, new drug delivery systems and new chemical entities.
"Many international companies are scouting for CROs with a specialised edge in generics and want an authentic study for their regulatory market entry and consolidation programmes. There is an increasing requirement for this service in the wake of shortage of capacity in the country. We will now go all out to attract international drug majors to opt for Manipal AcuNova for BA/BE in generics," D A Prasanna, vice chairman & managing director, Manipal AcuNova told Pharmabiz.
KMC Manipal AcuNova plans to capitalise the existing infrastructure of a 2,000-bedded hospital of the Kasturba Medical College apart from facilities at the MAHE University, which includes Colleges of pharmacy and biotechnology, and a modern animal house to address a wide gamut of clinical research opportunities including pre-clinical studies, pharmacokinetics, pharmacogenomics and clinical data management.
The centre also plans collaborative program for drug development and specialized services including clinical study development, generic drug development strategy and Training for Project teams, Abbreviated New Drug Application (ANDA) BE project management. "The clinical expertise and resources available to researchers at Manipal offers immense potential for clinical research in oncology, infectious diseases, endocrinology (diabetes), neurology and dentistry," he informed.
The 26-bedded BA/BE centre has dedicated areas for screening, counselling, phlebotomy, clinical, analytical and pharmacy. It also houses a state-of-art fully equipped Phase I Unit in addition to an ICU to handle emergencies. The in-house 25 clinical experts of KMC Manipal AcuNova will design, develop, study protocols customized to specific drugs and therapeutic targets. 'ClinOne', a customised clinical trial management system (CTMS), for volunteer recruitment has also been installed.
The certified bio-analytical laboratory can provide highly selective and sensitive assays of drugs, metabolites and endogenous compounds in bio-fluids using automated sample extraction, high throughput micro column analysis to rapidly analyse batches of varying size. A validated Laboratory Information Management System (LIMS) ARK would support all studies in accordance with 21 CFR Part 11 requirements.
MAHE's Pharmacogenomics core facility at KMC Life Science set-up under the research and development scheme from the Department of Science and Technology (DST) and Technology Information, Forecasting and Assessment Council (TIFAC), Government of India will also add value to its existing technological and clinical expertise to provide special insights in to drug efficacy.
The Bangalore facility located on the 9th Floor of the 650-bedded Manipal Hospital in Bangalore will serve as a CRO while KMC Manipal AcuNova and Manipal AcuNova, Mangalore will serve as a clinical reference labs.