Publication

Abstract : Thanks to the clinical research boom, Industry has witnessed many changes from economy to openings. The number of generic players has risen tremendously over years, which lead to the increased emergence of Bioavailability/Bioequivalence (BA/BE) clinical/contract research organizations (CROs). India, the home of most number of FDA approved manufacturing plants outside the US is now moving towards the generic revolution. With more products in the pipeline, the country is poised to consolidate her leading arm. Apart from the reduction of drug costs, generics increase drug use; prevent drug shortages; promote product rationalization and avoid supply disruption. Increased awareness of Good Clinical Practices (GCP) requirements, stronger desire of international acceptability of research done in India has brought favorable changes in the attitude of researchers in India towards human research. Like the multi-centric clinical trials, the number of CROs conducting BA/BE studies is increasing day by day offering plenty of opportunities to healthcare graduates/professionals, particularly for pharmacy graduates. The position in these CROs are promising and challenging with chances of conducting studies for various regulatory submissions. It gives the pharmacy professionals the much needed clinical experience in a country where the pharmacists are focused mainly on the industrial aspects. Transferable skills and the right attitude are much essential for a candidate to fetch an offer in this area. The profiles ranging from volunteer recruitment to report writing are discussed in this article.