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Overview
India is fast emerging as a favorable destination for conducting
global clinical trials. The availability of highly qualified medical practitioners, lower drug development cost, wide spectrum of
disease and skilled manpower proficient in English language is
attracting conduct of global clinical trials in Indian hospitals and
clinical sites. Since India has implemented GCP as per ICH global
standards, it is now possible that the data from conduct of trials in
India as per GCP guidelines maybe submitted for approval of the
drug in USA, Europe, Japan, etc along with submission to
authorities in India. The clinical trial industry is doubling in revenue
every 2 years and as per Mckinsey estimate India has the potential
to become one billion dollar revenue industry.
Current outsourced clinical trial activity in India is at around Rs. 3.5
billion (about US $ 75 million) and is estimated to go up to Rs.13
billion (about US $ 281 million) by 2010. Thus, there will soon be a
massive demand for clinical research professionals, making it an
interesting career option with massive growth potential. That’s not
all. Trained Clinical Research professionals will also be in demand
abroad. There are more than 2,50,000 positions vacant worldwide
and salaries in the U.S. vary in the region of approximately USD
40,000 p.a. for a Clinical Research Co-ordinator to almost USD
100,000 p.a. for a Business Development Manager. Rest assured,
Clinical Research is definitely the next big career and now is the time
to make it a vocation. With demand far outstripping supply, it seems
to be a win-win situation for the clinical research associates.
Course Details
Course Objectives
- Obtain a clear understanding of Good
Clinical Practice and Standard Operating
Procedure for Clinical Research andClinical
Data Management.
- Provide Individuals / Students / Professionals
from Pharmacy, Medical, Nursing,
Life Sciences, Research & Development,
Clinical Research, Allied areas and
Academic fields, a basic to advanced level
understanding of various clinical trial
processes.
- Enable participation in design, conduct and
management of global clinical trials,
conducted at multi-centric sites in India and
overseas.
- Acquire an understanding of evolving
regulatory processes, standards and
practices of ICH GCP in the conduct of
different therapeutic trials and in the
preparation of submissions to be made to
regulatory authorities in India and overseas.
- Support overall clinical trial process
electronically by implementing Electronic
Data Capture (EDC) system and Project
Monitoring.
Course Content
Module 1
- History and Evolution of Clinical Trials
- Clinical Epidemiology
- Introduction to Clinical Trials
Module 2
- Good Clinical Practices (GCP)
- Laws Governing Clinical Research
Module 3
- Ethical issues related to Clinical Research
- Clinical Data Management
- Clinical Research Budgeting
Module 4
- Statistics for Clinical Research
- Clinical Research Audit and Inspection
- Clinical Research Careers
Career Prospects/Benefits
Career prospects include a professional
career in Clinical Research industry either as
a clinical investigator, site coordinator in at a
hospital conducting clinical investigations or
CRO (Clinical Research Organization).
Jobs are also available in pharmaceutical
industry, drug development, medical writing,
and biostatistics or as a Manager of
Clinical Project, Clinical Research Business
Development, Clinical Operations, Data
Management, Regulatory Affairs and
Auditing of Clinical Trials.
2,50,000 vacancies available worldwide.
50,000 job openings in India by 2010*.
* McKinsey Report
Course Fee
Rs.25,000 in single instalment or
2 equal instalments of Rs. 14,000 each in favour of "Medvarsity Online Limited" payable at Hyderabad.
Duration
6 months Online study includes
1 week contact program at Apollo Hospitals,
Hyderabad. Boarding and Lodging in and around Apollo Campus during contact program.
Eligibility Criteria
Graduates in Life Sciences, Pharmacy, Allopathic
Medicine, Homeopathy, Ayurveda, Unani, Dentistry,
Paramedical Sciences, Physiotherapy, Allied Health
Sciences and Biotechnology.
Course Delivery
Online Study along with CD and printed study
material.
Evaluation & Certification
The course is divided into 4 study modules each
having an assessment. All these assessments are
online and objective.
The candidate is required to complete all internal
assessment tests and the contact program. Final
examination will be conducted online at the end of
the course. Successful candidates will be awarded
Certificate by AHERF and Medvarsity.
About Medvarsity
Medvarsity, India's first Medical e-Learning venture was established in April
2000, and launched its official online portal www.medvarsity.com in October
2000. It is an initiative by Apollo Hospitals Group, the leader in healthcare in
Asia Pacific Region having the first JCI accredited hospital in India and leaders
in providing e-Learning solutions.
About AHERF
Apollo Hospital Educational & Research Foundation (AHERF) conducts other
educational and training programs including Nursing, Master degree in
Hospital Administration, Physiotherapy, Emergency Medicine, Surgery and
Anesthesiology.
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