Clinical Research Professionals in India
India is emerging as a favorable destination for conducting clinical trials. By 2010, Indian clinical research industry is likely to attract revenue of $1.5 billion from United States and other European countries, which in turn will increase the demand of investigators and other clinical research professionals to a number of 10,000 and 50,000 respectively. With countries like U.S. and Europe outsourcing clinical trial studies to India, a number of global pharmaceutical companies and Indian entrepreneurs are setting up Clinical Research Organization (CRO) in India. CROs facilitate clinical trials of new medicine on human subjects before it is made available in the market. India has a total of more than 150 clinical research organizations including domestic CROs like iGate, Reliance Life Sciences, Fermish and international CROs like Omnicare and Icon. As a result demand for professionals from clinical research and knowledge process outsourcing has increased tremendously.
Clinical Research boom in India
The two major factors responsible for supporting clinical trial studies in India are listed below:
- The cost of conducting clinical trials in India is about 40-60% lesser as in western countries.
- Patient's recruitment is higher which has an advantage of reducing the time to market a new drug.
Based on these factors it is expected that the number of clinical trials will grow exponentially in over the next decade. In 2005, only 1% of global clinical trials were conducted in India, which is predicted to grow up to 15% by 2011 as the number of patients getting enrolled in clinical trials in India is likely to touch a figure of 300,000. Some other features which proves that Clinical Research Organizations in India has substantial capacity to meet the rapidly growing demand for clinical trials include:
- India has 300 universities, over 750 graduate and post-graduate programs, and about 50 million collage graduates.
- More than 700,000 medical and clinical research professionals and over 600 ICH/GCP compliant sites.
- Major steps are taken co-operatively by Indian Government and industry to strengthen the infrastructure for conducting clinical trials.
- Establishment of new GCP standards.
- Development of a number of comprehensive training program including some new graduate and post-graduate programs.
- English as a medium of transaction in higher education, business dealings and medical industries.
- Regulatory process to facilitate approval of protocol is streamlined.
As a result of these unique features, a complete group of GCP-trained clinical investigators has been created, which is supported by another group of trained clinical research professionals.
History of clinical research profession in India
Earlier pharmaceutical industries and evolving CROs were greatly focused on monitoring of clinical operations. As a result, only pharmacists working as Clinical Research Associates (CRAs) and Project Managers engaged in monitoring and handling clinical studies had flourishing careers. Gradually, science graduates and medical professionals stepped into the industry as CRAs and Project Managers.
Job opportunities in Clinical Research Organizations
Global and domestic Clinical Research Organizations in India offer a variety of job openings at different phases of drug development. These include:
- Project management
- Clinical trial monitoring
- Medical affairs
- Regulatory affairs
- Quality control
- Data management
- Statistical analysis
Some other industries providing supporting services for clinical studies have also developed parallely. Recently, a number of European countries have chosen Contract Research Organizations in India to outsource large-scale clinical data management and statistical analysis. IT- enabled service sectors are stepping into biometrics business and thus contributing greatly in creating sufficient opportunities in knowledge-based service sectors.
This indicates that career prospects with Clinical Research Organizations (CROs) in India and Site Management Organization (SMOs) is highly attractive.
Advantage like cost effectiveness and easy availability of clinical research professionals has encouraged bioanalytical and bioequivalence business in India. There are 15 reputable center for conducting short term trial and generating substantial revenue, which offer career opportunities for CRAs, physicians, nurses, Quality Assurance (QA) auditors, Principal Investigators (PI), biochemist, and biostatisticians.
Investigators with an ability to conduct ethical clinical research form the most critical part of this industry. Other ancillary career opportunities are available in central laboratories, investigational product manufacture, packaging, warehousing, distribution, and refrigeration service provider.
Clinical Research Training and Courses in India
Clinical Research Organizations are trying to gain expertise in clinical research by organizing training courses in ICH and GCP guidelines for their employees, followed by an exposure to their department specific training. These department specific training includes training in:
- Clinical Operations
- Data Management
- Regulatory System
- Medical Affairs.
Some organizations also offer on-job-training programs. Formal training courses for clinical research in India were not available until past few decades. Keeping in view the bright future prospects for this industry, a number of local and global universities have initiated full-time and short-term courses (both class-room based and online) in clinical research in India.
Summing Up
Accepting clinical research as a profession is becoming increasingly popular among students. To serve the increasing need of this industry, a number of universities and institutes are looking forward to introduce various courses on clinical research. It is expected that IT professionals with scientific knowledge and talent will contribute to the growth of this industry. India is rapidly improving upon various complexities of conducting clinical trials so as to emerge as a global leader in Clinical Research Organization industry of India.
