Search

Monday, August 26, 2013

Streams in Clinical Research

The following are the streams of clinical research.

  1. Medical affairs
  2. Clinical operations
  3. Biostatistics and Clinical data management
  4. Pharmacovigillance
  5. Medical writing
  6. Medical coding 

Who are the eligible for this field:
Who are having the qualifications - B.Sc., M.Sc., B.Pharm, M.Pharm, Pharm.D, MBBS, Physiotherapy, Nurse etc
All the above mentioned fields can get jobs in the streams of clinical research.

In Pharmacovigillance, B.Pharm, M.Pharm and Pharm.D having people are preferred mostly.
In medical writing doctors are preferred mostly.

Below is the image at what places the streams are working:





The actual clinical research process:
Flow and interactions of various parties involved in clinical research
Follow the numbers

Tuesday, February 5, 2013

Clinical Research


For the people who are from science background (BSc, MSc, B.Pharm, M.Pharm, Pharm-D, Bio Tech etc), clinical research field is the best way for career.

It is the only hope to get a nice job quickly at present situation in India.

Not only in India but also worldwide clinical research has very wide scope


Clinical research
The term Clinical Research refers to the entire bibliography of a drug from its inception in the lab to its introduction to the consumer market & beyond. Not every compound that is tested in the lab is marketed. Before a drug is marketed, it has to undergo several stages of development.

Hence Clinical research may define as a “branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic procedures & treatment regimens intended for human use.”
A clinical trial targets specific health issues in human volunteers. Performing clinical trials is one of the best methods in clinical research field for finding new treatments & practices for combating illness.
Clinical trials are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the quality of life of the patient.

SCOPE
It is very clear that India has become a very preferred destination for clinical research. The industry is growing exponentially and is expected to reach Rs. 7000 Cr by 2010. Statics shows that if India's clinical trial business grows to 10% of that in US by 2015, the industry will need approximately 50,000 clinical research professionals.
Any professionals from CRO (Clinical Research Organisation), Pharmaceutical, biotech, practising doctors and fresh graduates can apply for it. Salary states is high. As arond 700 Cr. expanditure is there for single research.
Clinical Research has emerged as a popular career choice in India and abroad. Holding a strong growth potential, a clinical research profile has become a calling for many. India being a land known for Ayurveda, Unani, Siddha, and Homeopathy besides allopathy, India is growing as the preferred destination for global clinical trials.

Career in Clinical Research
Clinical Research is a systematic study to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Clinical research has become a multi-billion and multidisciplinary industry. A number of factors favor India as a clinical research hub. There are numerous government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials.
India boasts of well-trained and qualified manpower, well versed in English. The research and the development process in India can be done at a more affordable price. More importantly, there is vast clinical material, which can be utilised, due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes, India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.

Eligibility Criteria: -
Graduate / final year graduation students in Life Science, Pharmacy, Medicine, Dentistry, Paramedical Science, Allied Heath Sciences and Biotechnology. A BSc.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.

Job Prospects: -
The demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. According to a survey, there are 2,50,000 vacancies available worldwide 50,000 job openings in India by 2010. Highest remuneration packages owing to the shortage of skilled professionals.

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. Bio-statistician is those who, perform statistical programming, design, and analysis for clinical trial projects.
CRM are Clinical Research Managers, they supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. 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. The clinical research industry worldwide is growing at unparalleled rate.
It has opened up new vistas for employment for a large number of trained professionals. The clinical trials market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the UK, and they form one-third of the total research & development staff. There are more than 2,50,000 positions vacant globally and salaries vary in the region of approximately USD 40,000 per annum for a Clinical Research Coordinator.

Contract Research Organization
A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support and/or services for clinical trials. CROs support the pharmaceutical, biotech and medical device industries as well as foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.). There are over 1,100 CROs in the world, despite continued trends toward consolidation (many CROs are being acquired in recent times or others go out of business). It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008 and down to 55% in 2009. One estimate had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

Top CROs based on the Industry Standard Research
  1. Quintiles
  2. PAREXEL
  3. Covance
  4. Pharmaceutical Product Development (PPD)
  5. ICON
  6. INC Research
  7. inVentiv Health (PharmaNet/i3)
  8. BioReliance


The following are the streams where you can get a job at present.
 Go for it....
  1. Clinical operations
  2. clinical data management
  3. pharmacovigillance
  4. medical writing
  5. medical coding