About Clinical Research:
About Clinical Industry
Clinical Research Industry is a bridge between the lab and market for new drugs and the market is expanding rapidly .India is emerging as a global hub for clinical research. According to projections from McKinsey & Company, the Indian clinical research industry could attract from US $1.5 billion of revenue from U.S. and European sponsors by 2010, creating a demand for more than 10,000 investigators trained in good clinical practice (GCP) and supported by nearly 50,000 clinical research professionals. Analysts project that by 2008, up to 30% of global clinical trials will take place outside the U.S. and Western Europe, and India has emerged as a favorable destination for these trials. Most regulatory authorities accept India-specific clinical trial data when launching a product globally. Registration of new drugs for marketing in India requires submission of data generated on Indian patients. A 100-patient, no comparative, open-label study on patients treated for the primary indication is sufficient. For drugs that treat rare conditions, a lower sample size is usually negotiable. With increased outsourcing from the U.S. and Europe to India, global pharmaceutical companies and Indian entrepreneurs have set up contract research organizations (CROs) in India. They are attracting highly competent professionals, both in the clinical research profession and the knowledge process Outsourcing sector.
Evolution of Clinical Research Professionals in India.
Contract clinical research is a new phenomenon in India. A decade ago, the industry focused only on the monitoring clinical operations. Most Pharmaceutical companies and the evolving CROs performed only clinical operations. Hence the career opportunities came only to the clinical research associates and project managers who could handle the studies.
In the beginning pharmacists had an edge over other clinical research professionals, but slowly the science graduates and medical and alternate medical professionals entered the industry as CRAs and project managers. Since then there has been a growing number of players on India’s stage.
