Clinical Research also called as Drug Development is one of the most sought after career opportunities that are gaining huge traction these days among students and aspirants. With the advent of liberalization India is poised to become one of the most preferred destinations for drug companies that are willing to develop and market drugs. With this article our main aim is to help students gain relevant knowledge and insights about Clinical Research and its career aspects.
What is Clinical Research?
Clinical research is a branch of medical science by means of which the safety and efficacy of a drug, diagnostic product, device and medications are determined. Many a times Clinical Research is interchangeably used with Clinical Practice which is not true. Clinical Practice has nothing to do with Clinical Research as Clinical Research is a vast field where a drug is developed, created and marketed to cure a particular disease. The outcome or product of the clinical research could then be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Phases in Clinical Research
The process of Clinical Research involves a number of phases like, Phase I, Phase II, Phase III and Phase IV.
Phase I: This is the first step in the overall process of Clinical research where the salt or the drug candidate is introduced in the body of healthy volunteers called as Subjects. The main aim of the process is to determine the “Safety” of the drug in human body. The parameters used in this phase include pharmacodynamics, bioavailability and pharmacokinetics of the drug. The impact of the drug in various organs of the body is also determined in this phase and is considered as one of the crucial phases and much of the success of the drug depends on it only.
Phase II: This is the second step in the overall process of drug development in which the drug candidate is introduced in limited number of patients to assess the efficacy of the drug. In this step subjects will have to be patients as this is the only phase that determines how effective a particular drug is.
Phase III: This is the third stage in the process of drug development in which the drug is exposed to a large number of patients with different genetic composition, and morphological variance. Most of the time phase III study is multi-centric, randomized and placebo controlled.
Phase IV: Phase IV is the last stage of the process and is also called as Post-Marketing Surveillance where the performance, safety and efficacy of the drug is monitored after it is being introduced in the market. Any adverse reaction case pertaining to the drug should promptly be reported to the respective regulatory authority and appropriate measures need to be taken to ensure safety.
Eligibility to get into the field of Clinical Research:
The field is a perfect fit for those individuals who are undergraduates and postgraduates degree holders in the Life Sciences, including molecular biology, bio-chemistry, physiology, biotechnology, bio-informatics and nursing. However, there are some scopes for non-life-science graduates as well like students with majors in statistics, mathematics and computer science. These non-biologists could excel in the field of bio-statistics, Data Management and others.
Career Opportunities: There are plenty of opportunities available after the completion of the course and candidates could expect a handsome salary and lucrative pay-packages once absorbed in the industry. Some of the important positions available are:
- Clinical Research Executive (CRE)
- Clinical Research Associate (CRA)
- Clinical Data Manager (CDM)
- Quality Assurance Analyst (QAA)
- Site Management Executive
- Site Monitoring Executive
- Clinical Trial Assistant (CTA)
- Clinical Research Associate (CRA)
- Senior CRA
- Clinical Team Leader
- Project Manager
- Senior Project Manager
- Manager –Safety / Patents
- Manager Medical & Regulatory
- Manager Quality Assurance
- Associate Director –Clinical
- Associate Director –Projects
- Medical Director
- Director –Business Development
- Director / Head (Clinical Operations)
- General Manger / CEO / President
Some Opportunities in the Data Management Field
- Data Entry Operator
- Data Manager
- Data Validation Executive
- QA Manager
- Data Base Designer
- Medical Writer
- Statistical Programmer
- Data Reviewer
- Head –Data Management
Some Important Recruiters and companies in this field are:
- Johnson & Johnson
- Novo Nordics
- Astra Zeneca
- GlaxoSmithKline Beecham
- Dr. Reddy’s Laboratory
- Bio-gen Idec
- Nicholas Piramal,
Some Important Clinical Research Organizations (CROs) that absorb Individuals are:
- Icon International
- Manipal Acunova
Some important hospitals that recruit these individuals are:
- Apollo Hospitals
- Bangalore Diabetes Hospital
- M S Ramiah Memorial Hospital