CLINICAL RESEARCH OVERVIEW

Clinical Research is a systematic study that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment & diagnosis. The entire process passes through various phases.

Phase I

The new drug is administered to a small number of about 20-80 healthy subjects under the supervision of a doctor. The objective is to determine whether the new compound is tolerated by the human body and is safe enough to be given to the patients.

Phase II

The compound is given to 100-300 patients to determine the effectiveness, pharmacological activity and adverse events.

Phase III

The study involves 1000 - 3000 or more subjects. The new drug is compared to a standard drug using specific clinical trial designs. Data is analyzed by using statistical tools to obtain commercial license from the regulatory authority.

Phase IV

The medicine is made available to doctors to prescribe to patients. The effect of the approved drug is analyzed in thousands of patients to evaluate the risk (side effects) versus benefits.

Opportunities:

India is becoming a hub for clinical research organizations. Present Clinical Research market in India is worth $1 billion. A large population with a substantial workforce and cost benefits influence multinationals to set up research centers in India. The prevalence of a large variety of diseases like cancer, infectious diseases, cardiovascular, and diabetes makes it easier to get subjects to participate in trials. Global Pharmaceutical Companies - Novonordisk, Novartis, Glaxo Smith Kline’s (GSK) have already set up facilities in different parts of the country and are scaling up operations rapidly. India is also at the forefront of cutting age technology such as stem cell research. Therefore India is viewed as ideal location for clinical research trials

Bangalore being the tech city in India has also attracted major software companies like Accenture, TCS, Aris Global, Cognizant and Symphony to enter into clinical research. Hence, the demand for professionals in this field is growing rapidly. At present there is a massive requirement for clinical research professionals. According to survey there are more than 50,000 jobs in clinical research in India & 3,00,000 jobs worldwide.

How to become a part of clinical research industry?

Graduates in life science and biotechnology, pharmacy, medicine & dentistry are ideal for clinical research.

Due to large number, large variety & overseas opportunities students prefer careers in clinical research.

Overseas Options:

Generally the MNC companies select Indian students for Jobs based in India. Once students pass through selection process they are immediately sent to overseas locations (Europe & USA) for focused training. Ex. Novonordisk which started operations in 2011 has sent selected candidates to Europe. Indegene sends newly recruited employees regularly to USA. With 2 to 3 years job experience in India candidates can also directly opt for overseas option independently

Job Opportunities:

Entry-level

Clinical Research Associate (CRA) / Clinical Research Coordinator / Business Development Executive / Clinical Data Analyst etc

Specialization

Regulatory Affairs / Regulatory Affairs Associate / Clinical Scientist / Safety Reporter / Medical Editor / Clinical Reporting / Medical Reviewer / Drug Safety Physician

Senior Level

Clinical Research Manager / Project Managers / Global Regional Project Managers / Business Developers/ Clinical Data Managers/ Clinical Research Investigator

Role

• Designing, implementing and monitoring clinical trials management
• Site management at corporate hospitals and labs
• Attending scientific, professional meetings and training courses as appropriate
• Perform statistical programming, design, and analysis for clinical trial projects.
• Planning, co-ordinating and providing statistical analyses, summaries and reports
• New Drug Applications and Biological License Applications Submissions
• Interactions with officials of Drug Control General of India
• Reviewing medical conditions & adverse effects of drugs
• To provide expert opinion
• Assist in preparation of presentations and manuscripts of scientific meetings and technical journal
• Quality Analysis
• Meeting Global regulatory timelines
• Interaction with overseas clients for international audit

This is a brief overview of roles. But there is wide variety of job profiles which could take you to different countries from time to time depending on your choice.

Remuneration:

Fresher’s with Clinical Research Domain can start their career with Rs. 3,00,000/- salary Per Annum & can reach up to Rs. 6,00,000/-within a couple of years. Salary is not a constraint for the candidates with expertise & domain knowledge in clinical research industry.