CLINICAL RESEARCH: A BOOMING INDUSTRY
Clinical research is a branch of healthcare science
that determines the safety and effectiveness (efficacy) of medications
(drugs), devices, diagnostic products and treatment regimens intended for
human use. Clinical research is broader umbrella that involves pharmaceutical
companies and academic research institutions. In brief, researchers focus on
improvement of drug molecules for human health.
CLINICAL TRIALS
Clinical trials involve study of drug molecules in healthy
individuals/patients to evaluate its effects on health-related ailments. The
clinical trials are conducted in accordance with approved protocol that
defines the kind of patient to be recruited, how long study will be
conducted, and to know potential of drug molecule from safety and efficacy
perspective.
INDIA – THE CENTER AND EVOLVING MARKET FOR CLINICAL
RESEARCH
India is considered as a global hub for conducting
clinical trials. India has tremendous growth potential in clinical research
due to their huge disease prevalence and treatment-naive patient pools. India
has a basket of opportunities for clinical research industry in the form of
skilled manpower and expertise, infrastructure, cost effectiveness, and
availability of english speaking investigators.
Despite of resource availability, India is still
lagging far behind their western counterpart due to the limited number of
recognized courses for training healthcare professionals involved in
executing the clinical trials. Hence, to meet the growing demands of trained
clinical research professionals we need more qualified, ethical clinical
investigators as well as skilled biostatisticians. To meet the demand a Post
Graduate Diploma In Clinical Research (PGDCR), Advance Diploma in Clinical
Research (ADCR), and Certificate course in Medical writing
(CCMW)/Pharmacovigilance (CCPV) course is need of an hour which is primarily targeted towards executing all the job
functions of a CRO and Pharmaceutical industries.
SCOPE OF CLINICAL RESEARCH IN INDIA
Indian pharmaceutical industry is one of the fastest growing sectors
of the Indian economy. The billion dollar industry is witnessing high demand
for qualified professionals in this fast-growing field. To build a career in
clinical research, basic education in this field is necessary. In India, the
clinical research industry comprised of Clinical Data Management,
Pharmacovigilance, Medical Writing, and Clinical operations.
CAREER OPPORTUNITIES
Pharmaceutical companies and contract research
organizations (CRO) are expanding significantly. This has resulted for
increase demand for professionals trained in clinical research domain that
are in lieu with the industrial requirement and standards. The clinical
research industry is expected to offer more than 50,000 jobs to the
professionals trained in clinical research domain. Despite of huge
requirement there is always a shortage of trained professional in India. In
the US there are 50, 000 investigator (FICCI report) whereas in India we have
significantly lesser number which is expected to increase nearly to 10,000 in
near future. Further, many pharmaceutical companies are migrating to set up
their base in India leading to more number of clinical trials and thereby
creating more job opportunities. Clinical Research Associates (CRAs) are
employed in both the hospital sector and the clinical research industry to
look after the progress of day to day clinical trial related activities.
After successful completion of course you can pursue your career as
Data Analyst, CRA, Clinical Research Coordinator, Project managers, etc in
various clinical research industries like TCS, Cognizant, IPCA, Cipla, SIRO,
Sciformix, Quintiles, Novartis, Pfizer, etc.
OBJECTIVES
Our course aims at realizing the following
objectives
·
Focus on the essential principles of clinical research and standard
regulatory controls necessary to study the safety and efficacy of a drug
·
Provide in-depth knowledge on the various domains of clinical research
·
Focus on management & soft skill learning
COURSES
1] Post Graduate Diploma in Clinical Research (PGDCR) - 9 months
2] Advance Diploma In Clinical Research (ADCR) - 6 months
3] Certificate Course in Medical Writing (CCMW)/Pharmacovigilance
(CCPV) - 3 months (each)
COURSE CONTENT
ADDITIONAL COURSE
Personality Development and Communication Skills
Mock interview preparation
STRUCTURE AND EVALUATION
The course will be delivered via lectures,
discussions, group assignments, and case studies, conducted by experts from
industry. These include the professionals from contract research
organizations or pharmaceuticals having vast hands-on experience in clinical
research domain. Evaluations will be based on objective and subjective
written tests at the end of each module.
ELIGIBILITY
Medicine: M.B.B.S/ B.A.M.S / B.H.M.S/B.U.M.S/ B.V.SC (Interns are also
eligible)
Dental: B.D.S /M.D.S
Pharmacy: B. Pharmacy/ M. Pharmacy/Ph.D
Life sciences: B.Sc./M.Sc. (Zoology, Botany, Chemistry, Biotechnology)
Biotechnology: B. Tech/ M. tech
Bio medical engineering
Allied health care professionals
Students awaiting final year exams (graduation &
post-graduation) are also eligible to apply
DURATION OF THE COURSE
Part Time Program- Comprehensive 3 months, 6 months and 9 months
Course Schedule: Total 4 hours weekend classroom training
Timings: Sundays: 9.30 am to 1.30 pm and 2.00 pm to
6.00 pm
FEES STRUCTURE:
Fees are kept nominal and within budget.
FOR FURTHER DETAILS CONTACT:
COURSE CO-ORDINATOR
Please mail us for any query at:
Email: clinovigilance@gmail.com
VENUE FOR COURSE (Only on Sundays)
Dr. V N Bedekar Institute of Management Studies
(BRIMS)
Building No. 4, CIDCO Bus stop, Near Thane Railway
Station,
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