Decoding lab language

Clinical research is an emerging industry with exciting opportunities. It is one of the sectors that’s recession-proof. In India, this industry is growing at a scorching 60 per cent a year.

The most sought after people in this industry are medical professionals, pharmacy professionals, information technology graduates and those who have graduated in life sciences and chemistry — organic, analytical and biochemistry.

The career opportunities include:

Clinical Trials

Clinical Research Associates (CRAs):  Based in CROs/ pharmaceutical companies, CRAs are responsible for the correct methods of documentation in hospitals where trials are being conducted. They are in demand in the clinical research industry since the number of trials in India is growing rapidly and the number of hospitals conducting clinical trials is also increasing. Clinical Research Coordinators (CRCs):  Based in hospitals, CRCs assist investigators in managing a specific trial. They help investigators complete informed consent and coordinate for clinical supplies, documentation etc.

CRCs report to CRAs. Due to a borderline overlap of job responsibilities, sometimes CRCs are designated CRAs in hospitals based on their experience and skill. Salaries range from Rs 15,000 a month at entry level to Rs 40,000 for someone with four years’ experience. Salaries for MBBS graduates could be higher by 20 per cent.

Bioequivalence Studies

BE studies are conducted for generic products on healthy human volunteers. They are conducted in one facility unlike clinical trials which take place in many hospitals/ sites.
Biostudies in India are very popular due to the general nature of the pharmaceutical industry that exists here and the regulatory scenario.  Opportunities in this area are mainly categorised into Clinical and Bioanalytical.

Clinical operations require counsellors, clinical research coordinators, clinical report writers, clinical quality assurance experts etc. A course on clinical research is sufficient to obtain a job in this field.

Specialised skills are required to handle the specialised equipment in this field. A person with pharmacy and chemistry background is best suited for this course. This field has recorded phenomenal growth in the last decade, creating a huge demand for trained manpower.  The requirement varies from chemists, scientists, quality assurance experts, technical support staff, report writers etc.

Salary in the bioanalytical field starts from Rs 15,000 and grows much faster than other areas in clinical research. At the end of 5 years, a successful scientist can look forward to a salary of Rs 1 lakh a month.

Data Management

Clinical Data Management (CDM) is growing at the rate of 40 per cent a year in India. It requires specialised training on software accepted by USFDA. There are many institutes offering CDM courses in India.

Before enrolling for the course, candidates must check on the duration of practical training offered on the software. Opportunities in this area include data entry, data management design, medical coding, analysis, statistics etc. The entry level salary is around Rs 12,000 and can go up to Rs 40,000 in about 4 years.

Pharmacovigilance

Though pharmacovigilance is in its infancy in India, it is emerging as one of the fastest growing fields in the clinical research sector. It is gaining importance due to measures taken by regulatory bodies in USA and Europe as well as the World Health Organisation, which  in the recent past, have prescribed stringent reporting formalities on the adverse effects of drugs.

Pharmacovigilance will boom in the coming years in India due to low costs, skill sets it offers in terms of basic medical education and software proficiency. A career in this field involves sound medical knowledge and software skills. The most sought after professionals in pharmacovigilance field are MBBS/BDS graduates.

Other opportunities

Other areas in Bioequivalence Studies include Pharmacokinetics and Biostatistics, which are both highly specialised.  This area of work requires knowledge of software and flair for mathematics and analytical abilities. There are very few institutes offering courses in Pharmacokinetics and Statistics with specialised software training.

Clinical trials are a growing market worldwide. While the opportunities for clinical research professionals is well established in the US and Europe, countries like Malaysia and Vietnam are fast catching up on the infrastructure to cater to regulated markets.

India offers the best skills which these countries are making use of, to set up compliant clinical research infrastructure. Many Indian companies, which have set up base in Japan and China, are breaking language barriers and are very successful. 

Clinical research training in India is fast emerging as a front runner in offering best career opportunities. Ethics and quality play a pivotal role in carving a niche in this industry.