Clinical Research
Programmers and analysts are the IT/ computer professionals who design and implement applications in support of clinical research and bio-statistics. Bioinformatics scientists assist in the development of software and custom scripts to automate data retrieval, manipulation and analysis, application of statistics, and visualization tools.
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The
process of clinical research involves investigators conducting study.
These investigators can be researchers, professors, medical
practitioners and scientists/ medical specialists. Apart from these
there are those who participate in a clinical research. These people are
referred to as the subject of the research/ trial/ study. The criteria
for being a subject of a research are being a healthy and patient
volunteer. Clinical research is conducted through various phases the
ultimate purpose of the research being to prioritize safety. Phase one
involves human testing that is in most cases, performed with healthy
subjects. Phase two and three test the safety and efficacy of the new
drug in comparison with the other drugs or placebo. After a drug has
been cleared, the first three phases it may be given a Marketing Authorization (MA).
Next follows the trials, i.e. Phase four and post-marketing surveillance. During this phase, researchers continue to gain more information on the safety and efficacy of the drug as well as highlight the rare side effects that may only be seen after a large number of people have used the drug.
Next follows the trials, i.e. Phase four and post-marketing surveillance. During this phase, researchers continue to gain more information on the safety and efficacy of the drug as well as highlight the rare side effects that may only be seen after a large number of people have used the drug.
Course connect:
Optimally,
training begins at the undergraduate level. Undergraduate and post
graduate degree holders in life sciences, includes nursing, physiology,
biochemistry, molecular biology or pharmacy are potential candidates for
entry level positions. Aspiring clinical researchers could pursue
medical studies, pharmaceutical studies or life sciences and then enter a
doctoral program in their field of interest. A doctorate in public
health is a good career choice for those who are interested in the
incidence and prevalence of diseases. People who prefer medical research
can pursue a doctorate in biological or physical sciences or might
consider a post graduate degree in medical science. Post doctoral
training in specialty research area would be available with medical
research institutions/ laboratories and universities. Specialized training in clinical research or for clinical research jobs is mainly
available as a part-time diploma course. Few post graduate degree
courses in clinical research are also available.
Job prospects:
Career
prospects include a professional career in the clinical research
industry either as a clinical research investigator or a site
coordinator at a hospital or CRO (Clinical Research Organisation)
conducting clinical investigations. Jobs are also available in the
pharmaceutical industry, drug development field, medical writing and bio-statistics or even as a manager of clinical research business
development, clinical projects, clinical operations, regulatory affairs
and auditing of clinical trials.
Bio-statisticians provide guidance for statistical analysis methodology and perform
stastical programming, design, and analyses for clinical trial projects.
Programmers and analysts are the IT/ computer professionals who design and implement applications in support of clinical research and bio-statistics. Bioinformatics scientists assist in the development of software and custom scripts to automate data retrieval, manipulation and analysis, application of statistics, and visualization tools.
Future focus:
India
has one of the highest numbers of people afflicted with diseases with
genetic diversity. Further more, since the country has implemented GCP
and has a huge number of highly qualified medical practitioners, a
number of global clinical trials and researches in hospitals and
clinical sites from across the globe are being conducted here. Most US
and European nations are outsourcing clinical trials to India. A number
of prominent pharmaceutical companies too are outsourcing business
related to clinical research to India. Outsourced clinical trial
activity in India is estimated to go up to Rs.26.2 billion from Rs.10.5
billion by 2014. Additionally this industry is doubling revenue every
two years and as per McKinney estimates, India has the potential to
become a one billion dollar revenue industry.
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