Asian Clinical Trials Private Ltd, ACT in short, is the only CRO-based company in Hyderabad providing pre-clinical to phase IV clinical studies. ACT offers a range of services to guide pharmaceutical, biotechnology and medical device companies in getting their new products reach the market. ACT services include assisting client companies during product development, with focus on first-into-man-clinical evaluation through to product commercialisation.
Established in April 2001 by Venkat Jasti, Managing Director of Suven Pharmaceuticals Ltd, ACT has already completed two phase-III studies on a vaccine for infectious diseases and a recombinant product for cardiology. Studies have also been completed on Bioavailability (BA) and Bioequivalence (BE). Three more studies have been taken up since March 2003, according to Dr Sudhakar Bangera, Project Manager in-charge of ACT.
Feasibility studies for American companies have been completed on Oral Contraceptive Pills (PMS study), Assisted Conception (phase II study of 100 patients at 10 sites), Bronchial Asthma (phase II& III study of 45 and 270 patients respectively) and Lung Cancer (phase II study on 110 patients at 10 sites).
Dr Sudhakar told Chronicle Pharmabiz that ACT was composed of highly experienced professionals in the field of clinical trials. " ACT designs and conducts for both small and large national and multinational pharmaceutical, biotechnology and medical device companies pre-clinical and clinical phase I to IV trials without compromising on ICH-GCP standards."
Pre-clinical studies are performed using a range of laboratory animal species that include rat, mouse, hamster, rabbit, and in some cases, Rhesus monkey. All standard routes of administration are in routine use (including oral gavages, dietary admixture, IV bolus and continuous infusion) and wide ranges of non-standard routes are available.
The phase-I clinical studies include Pharmacokinetics and Pharmacodynamic Measurements, covering the cardiovascular system, respiratory system, central nervous system, autonomous nervous system, anti-histaminic and gastro-intestinal. For the phase II, III and IV studies ACT project management team provides the leadership to plan and integrate cross-functional activity to keep the projects on time and within budget with devotion to quality assurance throughout.