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This is a specially designed program to provide theoretical and practical training in coordinating clinical trials and clinical research efforts. The one-year diploma course will involve lecture components on key aspects on clinical research: namely, Statistical design and analysis, ICH/GCP Guidelines, Study design, Data management, Pre-clinical drug development strategies and methodologies, legal and regulatory aspects of clinical trials, ethical aspects and some exposure to pharmacology, anatomy and physiology. |
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In addition to the lecture component, unique aspect of this course is direct involvement with ongoing clinical research programs and an opportunity to manage and coordinate an existing clinical research project under the direct guidance of the Principal Investigator. Each student will receive one-on-one attention in this practical component of the diploma course. A student may reach a level of involvement in an existing clinical research whereby they would need to make an Institutional Scientific Review Committee and Institutional Ethical Committee Presentation. They would also need to prepare and present project reports. In short, each graduate student will be immediately ready to be absorbed as a clinical research coordinator at the end this program.
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CAREER OPPORTUNITIES : |
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There is a huge demand for qualified and trained Clinical Research Professionals. Clinical Research as well as pharmaceutical industries is rapidly expanding in India, creating exciting opportunities for trained professionals. During the last 3 years it has increased from Rs.20 crores to Rs.100 crores. Clinical Research industry would offer 50,000 jobs by 2010. According to a recent McKinsey report, by the year 2010, the industry is expected to grow up to Rs.5,000 crores. There is a shortage of trained manpower. India has about 500-1000 investigators; while US has 50,000 investigators (Source, FICCI). It is projected that India will need at least 10,000 investigators by 2010. With the implementation of product patent regime from 2005, many international pharmaceutical companies and CROs have set up their R&D base in India leading more number of clinical trials and the job opportunities.
Clinical Research Associates (CRAs) are employed in both the hospital sector and the research industry and can advance to management roles. Clinical teams work in a broad range of research settings, including: Academic health centers, Research organizations, Companies involved in Pharmaceuticals, Biotechnology and medical device firms. Pharmacy and Science Graduates can look forward to rewarding careers as Clinical Research Associates, Clinical Research Coordinators, Project managers etc. Clinical Research Associates play a very important role in monitoring and overseeing the conduct of the clinical trials in order to meet international / national guidelines as also national regulatory requirements. Clinical Research Associates can progress to become Clinical Research Mangers. Their role is usually within the clinical or medical departments of a Company or in a Contract Research Organization |
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COURSE STRUCTURE : |
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| 1st SEMESTER (22 Credit Points including 11 Credit points for Practicals & Project work) |
| Module |
Subject |
Credits |
Coordinator |
| 1 |
Fundamentals of Clinical Trials (including ICH-GCP) |
02 |
Dr.Gopi Chellan |
| 2 |
Allied Health subjects-Anatomy, Physiology, Biochemistry |
03 |
Dr.Kannan Vaidyanathan |
| 3 |
Pre-clinical Models-Drug discovery & development |
02 |
Dr.Poppy Rajan |
| 4 |
Biostatistics & Research methods in Clinical research |
02 |
Prof.K.R.Sundaram |
| 5 |
Business Development, Communication Skills & Personality development and Computer training |
02 |
Dr.Sanjeev Singh |
2nd SEMESTER (22 Credit points including 15 Credit points for Practicals & Project work) |
| 6 |
Project protocol preparation & Funding |
01 |
Prof.D.M.Vasudevan |
| 7 |
Clinical Trial Operations and Data Management |
02 |
Prof.Harish Kumar |
| 8 |
Project Planning and Management |
02 |
Dr.R.Krishna Kumar |
| 9 |
Regulatory & Legal consideration in Clinical Research |
01 |
Dr.Chandrasekhar |
| 10 |
Quality Assurance and Quality control in Clinical Research |
01 |
Prof.Ravikumar |
Practicals /Project Work |
| 1 |
Clinical Trials |
20 |
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| 2 |
Pre-Clinical studies |
06 |
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Total Credit Points |
44 |
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Each Credit point is 10 hours |
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FEES : |
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Fees for the course is Rs.2.00 lakhs. Application forms should be submitted by 25th,June,2008 along with an
application fees of Rs. 500/-, Demand draft made in favour of ‘Amrita Institute of Medical Sciences’, payable at Kochi. |
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Download Application form and terms & conditions : |
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Application Form || Terms & Conditions (pdf Format)
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CONTACT INFORMATION : |
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Head of the Program:
Dr.Shanti Nair( Dean of Research)
shantinair@aims.amrita.edu
Tel : 0484-4008751
Program Co-ordinator
Prof.K.R.Sundaram(Head,Department of Biostatistics)
krsundaram@aims.amrita.edu
Tel : 0484-2801234/ 8184
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AMRITA |
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In reality, the more you observe, the more you will realize that love is the force behind all scientific experimentations and inventions; it is behind all work. Love sharpens the intellect. The more love you have, the more sharpness and clarity you will have. You may call it a sharp or subtle intellect, but it is working behind that sharpness or subtlety
Amma |
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