Clinical Research

• What is Clinical Research?.
  
  A clinical research is a scientific study of the effects, risks,
  efficacy and benefits of a medicinal product. These are carried out
  prior to the release of the medicine in the market. These trials are
  undertaken at various stages and studies are conducted after the launch
  of a new product to monitor safety and side effects during large-scale
  use. Clinical trials are conducted by pharmaceutical companies or
  contract research organisations (CRO's) on their behalf. It is this
  sector that is driving the growth in clinical research in India.
  
  
  
  So, what does one need to become a part of this rapidly growing industry?
• Eligibility.
  
  A B. Sc. degree is a must to enter this field. Ideally the industry is
  looking for science graduates from pharmacy, medicine, life science and
  bioscience. Within bioscience too there are various other fields such
  as botany, zoology, biochemistry and genetics. Anybody who fulfils
  these criteria can join the industry.
  
  
  
  Individuals with prior work experience of 2-3 years are preferred, but
  like the BPO industry, there is a dearth of trained professionals here
  too. Thus, with the right qualifications finding a job in clinical
  research should not be a problem.
• Job Profile.
  
  Clinical Research branches off into various categories at the entry level.
  
  
  
  The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied,
  
  • They are key participants in the design, implementation and monitoring of clinical trials
    
    
  • They
    shoulder the responsibility of planning and implementing all activities
    required to conduct and monitor complex clinical trials and ensure that
    Good Clinical Practices are followed.
    
    
  • They
    assist in preparation of presentations and manuscripts of scientific
    meetings and technical journals and attend scientific/professional
    meetings and training courses as appropriate.
  
  BIOSTATISTICIAN are those who,
  
  • 
    Perform statistical programming, design, and analysis for clinical
    trial projects. Planning, coordinating and providing statistical
    analyses, summaries and reports of studies is also a part of their job
    profile.
  • In addition they are responsible for New Drug Applications and Biological License Applications submissions.
  
  CRM are Clinical Research Managers,
  
  They supervise design and writing of protocols, case report forms and
  informed consent forms for clinical trials. They ensure that Case
  Report Forms are reviewed in a timely fashion and submitted to the data
  management group. There are other posts too such as Clinical Research
  Coordinator, Business Development Manager, Clinical Research
  Investigator, Clinical Data Manager etc.
• Remuneration.
  
  There is high demand for trained professionals in this field; the pay package is impressive at the entry level.
  
  • Freshers can expect a pay packet of around three lakhs or more per annum.
  • If you have a master's degree backing your qualifications, then the amount is almost doubles.
  • 
    Clinical research is an industry where experience counts, thus the
    longer you are in this field; higher the salary you can expect.
  
  
• Growth Prospects.
  
  There are various growth opportunities along the way for those willing
  to learn. For those interested in serious research work, a PhD is the
  ideal solution. There are post graduate degrees and diploma's offered
  by various colleges which come in handy to enhance one's career
  prospects. Specialization in branches of pharmacy, life sciences,
  biochemistry will be useful.
  
  
  
  Studying further will also help one in bettering their current job
  profile. For instance doing a masters will enhance the job prospects of
  a CRA to become a Project Manager. Similarly a PhD in a related
  discipline is needed to become a Medical Director.According to industry
  reports, India is the second largest pharmaceutical market in Asia
  growing by more than nine per cent annually. According to a report,
  there are more than 50,000 jobs in clinical research in India .Lack of
  experience is no longer a hindrance, and companies are hiring from
  other streams too. With the influx of multinationals setting up
  research facilities here, the industry is poised to grow exponentially.
  
  
• Where to Study?.
  
  • Academy for Clinical Excellence (ACE) Website: www.aceindia.org It
    offers courses like Clinical Research; From Theory to Practice,
    clinical Research and GCP for investigators, Quality assurance in
    clinical research etc.
    
    
  • Institute of Clinical Research (ICRI) Website: www.icriindia.com It offers the following courses:
    
    
    
    • Two year full time - Masters in Clinical research + MBA
    • Two year full time - MSC in Clinical Research
    • Part-time post graduate diploma in Clinical Research (1 year)
    • PhD in Clinical Research.
    
    
  • Bombay College of Pharmacy: Website: www.bcpindia.org Offers Bachelors, Masters, and Doctoral programme of study in Pharmaceutical Sciences.
  • 
    Cliniminds - Academy for Clinical Research Training & Management - Website: http://www.cliniminds.com -
    institute offers wide range of clincial research courses; diploma
    programs in Pharmacovigilance; Quality Assurance in Clinical Research;
    Biostatistics; Investigators; GCP Training; Monitoring and several
    other programs.
  
  There are many more reputed institutes in India and abroad imparting expertise in Clinical Research!