Prof. Umesh V. Banakar, the US-based world-renowned pharma consultant and academician, has floated a 50:50 joint venture with the promoters of Chennai-based Chemech Laboratories Ltd. to initiate the first of its kind global standard CRO facility for clinical trials and bioanalytical services and support in Chennai.
Disclosing the new joint venture, T S Jaishankar, Managing Director of the new CRO - Quest Life Sciences Pvt. Ltd., said the company would provide quality clinical, bioanalytical and data management support to facilitate the international introduction of generic products, research on novel drug delivery systems and clinical development of new chemical entities as per GCP, GLP standards laid down by ICH/WHO/FDA.
Jaishankar revealed Quest has become the first CRO in the country to bag orders for clinical trial from a leading US company, and more global orders were in the pipeline. The company targets a turnover of Rs.7 crore in the first year of operation with about 150 studies, and Rs.30 crore by next year. The current facility has capacity for 30 studies per month and about 250 to 300 studies in a year. Within the next six months, the company would expand marginally to set up the requisite infrastructure for conducting Phase III clinical trials, said Jaishankar.
Slated to take off within a few weeks, Quest has set up one of the largest clinical facility in compliance with GLP, GCP guidelines situated at the Madras Export Processing Zone (MEPZ), about ten kilometers from the Chennai airport for the convenience of international clients. Quest also has an administrative office in Indianapolis, USA, headed by Dr.Banakar, the Chairman of the company.
The centre has world standard modern infrastructure, including safety aspects like electronic keycard or fingerprint-controlled access for entry and exit at all times. The fully equipped ICU's with 50 beds per each unit and related paraphernalia have separate subject screening and sampling areas for phase I and phase -II-a.
The bioanalytical facility lab is equipped with modern equipment. Quest would offer clinical services like Phase I to IV studies with pathology and diagnostic services, bioequivalence assessment of generic dosage forms (ANDA), NDDS products, NCEs Phase I-III evaluation (NDA), preclinical Pharmacokinetics of NCEs molecules, therapeutic drug monitoring and clinical trials (Phase I - III) for evaluating safety and efficacy of NCEs.