Another venture of Sharda Group of Institutions (North India’s largest educational group) introducing
Post Graduate Diploma in Clinical Research (PG Dip CR)
One year Full time including 4 months internship with Thesis/ Project submission
Download brochure in .pdf fromat
What is clinical research?
Clinical research is organized research on human beings intended to provide adequate information on the use of drug/ device or a treatment on its safety and efficacy
CLINICAL RESEARCH FACTS SHEET:
- Clinical research next big career in India
- The global clinical trial outsourcing to India is estimated to reach around Rs 5000 Crores by 2010
- Approximately 50,000 clinical research professionals will be required by 2010
- High demand of clinical research professionals across the globe
The Phases of clinical research
The clinical testing of experimental drugs is normally done in four phases, each successive phase involving a larger number of people. |
| I ) Phase One Study:
Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. |
| II) Phase Two Study:
Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to several years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the comparative information about the relative safety of the new drug, and its effectiveness. |
| III) Phase Three Study:
In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years.
A drug can be sold to market once it passes phase III study |
| IV) Post-Marketing -- Phase Four Studies
In phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. |
CLINICAL RESEARCH INDIAN OVERVIEW
India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential.
Clinical research is all set to become the next big thing in India. A large population with a substantial workforce and cost benefits influence multinationals to set up research facilities here. Besides due to the prevalence of a large variety of diseases India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry
OVERVIEW OF COURSE
Post Graduate Diploma in Clinical Research (PG Dip CR) Full-time
(One year Full time including 4 months internship with Thesis/Project submission)
This first-of-its-kind one-year Diploma programme in India is comprehensively-structured and internationally-styled to match academic standards with industry requirements.
The course provides will provide students with a broader perspective of clinical research at Hospitals, Pharmaceutical companies, Clinical Research organizations and Regulatory bodies
Total intake 100/year
(5 days a week) 10 AM to 2 PM)
Note: Free laptop will be provided to every student
Minimum Eligibility:
-
Graduate in Health sciences (MBBS/ BDS/ BAMS/ BHMS/ BUMS/ BVSc)
-
Graduate in allied health sciences (BPharm/ BMLT/ BScMLT/ BPT/ BMIT/ BScMIT/ BHIA/ BScHIA/ BSc Pathology/ BSc Radiology)
-
Graduate in life Sciences BSc (Biotechnology/ Botany/ Zoology/ Microbiology/ Chemistry/ Nursing/ Home Science/ Food & Nutrition
Objectives:
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Practical knowledge of clinical research and in depth understanding of Good Clinical Practices
-
Providing trained personals to clinical research organizations, Pharmaceutical companies, regulatory agencies, Life sciences institutions, academic research institutions, clinical research sites and hospitals
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Training of designing, conduct and management of clinical trials at national and international level.
-
Thorough understanding of regulatory processes
PROGRAMME STRUCTURE
Module 1: Duration: 2 months
| S no. |
Topic |
1 |
Introduction of clinical research/Drug development process. |
2 |
Basics of anatomy, physiology relevant to clinical research |
3 |
Basics of Pathology & microbiology relevant to clinical research |
4 |
Pharmacology/Pharmacy relevant to clinical research |
5 |
Roles & responsibilities of Personnel in clinical research |
6 |
Regulatory process/ Schedule’ Y’/ /International regulation in drug development |
Module 2: Duration:2 months
| S no. |
Topic |
1 |
Bioequivalance studies in drug development |
2 |
Bioethics, IRB, EC/Informed Consent process in clinical research |
3 |
ICH-GCP guidelines, Good manufacturing practices, Good laboratory practices |
4 |
Standard operating procedures (SOP) Writing , development of Clinical trial logs |
5 |
Medical writing ,Clinical study report, Case Report Form, Protocol designing |
6 |
Medical coding/ SAS programming/ Introduction to MedDRA®/ COSTART/ WHO-Drug |
Module 3: Duration: 2 months
| S no. |
Topic |
1 |
Information technology in clinical research /Electronic data capturing for clinical trials |
2 |
Clinical operations/ Site selection & Project management & site management |
3 |
Quality control & Audit in clinical research/Intellectual property rights & data exclusivity |
4 |
Pharma covigilance & safety monitoring |
5 |
Biostatics, Clinical data management, Drug accountability & management |
6 |
Clinical trial Monitoring & Report development |
Module 4: Duration: 2 months
| S no. |
Topic |
1 |
Outsourcing in clinical research |
2 |
Business development & strategic management |
3 |
Medical marketing in Pharmaceutical industry, Medical coding |
4 |
Presentation/Communication skills/Personality development in clinical research |
5 |
Clinical trial financial management |
6 |
Thesis/ Project writing |
Internship at Clinical research organization/ Clinical research site/ Pharmaceutical company
4 months (includes Thesis/Project submission) |
Teaching methodology:
Regular class room lectures, seminars, tutorials group discussions, case presentations and an internship
Also included in training different assignments, projects to familiarize with real life clinical research situations and additional guest lectures along with providing opportunities for personalized interaction with eminent faculties, authorities, experts working in clinical research industry, institutions and regulatory bodies
Infrastructure
-
Separate well equipped laboratories in clinical research (BA/BE studies lab, Investigational product lab, Clinical reference lab, Clinical information lab etc.)
-
Hi-tech tech lecture theaters, seminar rooms, demonstration rooms and conference room equipped with projectors and computers
-
World class infrastructure supported by in house 500 bedded multi-specialty hospital & clinical research Centre
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A well-stocked library with latest books, periodicals, newspapers, journals, prints and records related to clinical research
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Wi-Fi computer labs to aid students in data search and computer-aided study.
ADMISSION PROCEDURE
Application form along with resume
Screening according to merit and final selection
CLINICAL RESEARCH AT SHARDA HOSPITAL:
Sharda hospital is a socio-corporate hospital situated in NCR (Greater Noida), run by Sharda Group of Institutions. Hospital is established to offer medical facility to the needy patients in and around Greater Noida, India and abroad. Hospital is equipped with all modern facilities and sophisticated medical equipment, with the objective of providing comprehensive healthcare under one roof to all sections of the community. The departments are headed by highly qualified and experienced consultants; many of them are renowned doctors in their respective fields
Clinical research division at Sharda Hospital: Clinical research division of Sharda hospital has already started clinical research activities. A number of clinical research projects sponsored by national and international organizations and pharmaceutical companies taken up by a dedicated team of qualified investigators, co investigators and clinical research coordinators are already in progress. The students getting clinical research training at Hindustan Institute of Medical Sciences & Research will get hand on experiences in all clinical research activities going on at Sharda hospital.
Ethics committee at Sharda Hospital: Ethics committee of Sharda hospital has been established as per norms mentioned in modified schedule ‘Y’. The ethics committee holds regular meetings to monitor clinical trials going on at Sharda hospital. All clinical research activities at Sharda hospital are conducted according to good clinical practices after approval of hospital ethics committee. The students will get a thorough understanding of ethical requirements and hand on practical exposure of ethical environment for clinical trials.
FACULTY LIST HINDUSTAN INSTITUTE OF CLINICAL RESEARCH
 Dr C M Kamaal
MBBS, DCH, MD
Incharge Clinical research Division, Sharda Hospital
Programme Coordinator: Clinical research
He served at Manipal Acunova (a Manipal group company) as Clinical Research Physician where he handled wide ranges of clinical research activities. He joined academics with HIMSR and continued his work in the field of clinical research. Author of book ‘Drug Therapy in Paediatrics’
Dr. Kamaal is responsible for establishing Department of clinical research at HIMSR. He is Secretary General of Institutional Ethics Committee and working as investigator for many clinical trials running at Sharda Hospital.
Contact: 9958032288
Mail: drkamaal@gmail.com
Permanent Faculty:
Dr B K Dhoan MS
Professor of Orthopaedics
Director & Principal HIMSAR
Dr U S Roy MD
Professor of Anaesthesia
Medical Superintendent Sharda Hospital
Dr Rashid Ali PhD
Professor of Biochemistry
Dr Vinod Bhardwaj MD
Professor of Pharmacology &
Therapeutics
Dr C M Kamaal DCH, MD
Incharge Clinical Research Division
Sharda Hospital
Dr Sukanta Sen MD
Asst. Professor (Pharmacology &
Therapeutics)
Manoj Garola MSc Dip CR
Lecturer (Biostatics)
Dr Ashish Roy MHA
Director(Admin) & Add Medical
Superintendent Sharda Hospital
Dr Ranjana Singh MD
Asst. Professor (Biostatics & Preventive
Medicine)
Dr Nirupama Gupta MD
Asso. Professor (Anatomy)
|
Dr Jaybhallabh Kumar MD
Asst. Professor (Clinical Physiology)
Dr Barkha Gupta MD
Asst. Professor (Toxicology & Medico
legal affairs)
Dr Veena Gupta MD
Asst. Professor(Clinical Biochemistry)
Dr Anuradha Makkar MD
Asso. Professor (Clinical Microbiology)
Dr Sarita Deodhar MD
Asst. Professor (Clinical Pathology)
Dr Pradeep Tyagi MD
Asst. Professor (Anaesthesiology &
Intensive Care)
Dr Satender Kumar MS
Asst. Professor of Surgery
Dr Subhash Chandra MD
Asst Professor (Paediatrics)
Dr Ruchi Srivastava MD
Asst. Professor (Gynaecology &
Obstetrics)
Dr Sanjay Pandit MD
Asst. Professor (Internal Medicine) |
Dr Sanjeev Roy MD (AIIMS)
Clinical Investigator
Fortis Clinical Research Ltd, .Faridabad
Parijat Nandy M Pharm
Clinical Project Manager
Allergan Pharmaceutical Development Centre India Pvt. Ltd. Bangalore
Dr Vivek Garg MD
Medical Advisor
Novo Nordisk India Pvt Ltd
Mr Amit Sahu M. Pharma PDCR
Fortis Clinical Research Ltd, .Faridabad
Dr Mohd. Amin Mir MS, MSc
Officer Quality control
Fortis Clinical Research Ltd, .Faridabad
|
Dr Shilpa Puthran MD
Head Clinical research
Metropolis Health Services (Main
Lab), Mumbai
Dr Jaysheel B G MD
Manager Clinical research
Manipal Acunova Ltd Bangalore
Dr M Khalid
MBBS, MAGS (USA), MCP,
Software Consultant (Medical Domain),
Tata Consultancy Services, Hyderabad
Mr Muneeb Ahsan B Pharm
Senior Research Coordinator
Clinsys Clinical Research, Ltd. Noida
Syed Ziaul Abrar Hussain MPhram.
Research Coordinator
Clinsys Clinical Research, Ltd. Noida |
Padam Shree Dr R R Chaudhry MBBS, FRCP
Director
Task Force for Clinical Research
Apollo Hospitals Educational & Research Foundation
Dr Kohkan Shamsi MD, PhD,
CEO
AcuNova Life Sciences US
Dr K D Tripathi MD
Ex Director Professor & Head of Pharmacology
Maulana Azad Medical College & associated G B Pant Hospital
New Delhi
Mr Moin Don M. Pharm
Head Pharmacovigilance
Asia Pacific region
Johnson & Johnson Ltd Mumbai
CARRERS IN CLINICAL RESEARCH
A number of positions are available in clinical research industry depending upon qualification and experience
- Medical Monitor
- Content developer
- Faculty Clinical research
- Medical Writer
- Clinical team leader
- Clinical development manager
- Protocol manager
- Principal investigator
- Medical advisor
- Manager-Medial services
- Manager Medical affairs
- Manger Clinical research BA/BE services
- Regulatory affair associate
- Clinical Research Physician
- Clinical SAS programmer
|
- Clinical data coordinator
- Biostatistician
- Statistical analyst
- Officer Quality control
- Head quality control
- Manger Quality control
- Patent analyst
- Clinical Research Associate
- Clinical Research Coordinator
- Manager Clinical operations
- Head Clinical trials
- Clinical project manager
- Zonal Manager-Clinical trial
- Executive business development
|
- Regional monitor
- Interactive trial analyst
- Clinical trial executive
- Clinical trial analyst
- Support analyst
- Clinical programming analyst
- Head Medical informatics
- Business development associate
- Regional business manager
- Manager marketing
- Business development manager
- Area business manager
|
Companies employing Clinical Research professionals
■ Abbott
■ Accenture
■ Accutest
■ Actrec
■ Aditya Birla Memorial Hospital
■ Aditya Jyot Hospital
■ AIIMS
■ Ajanta Pharma
■ Akela Pharma
■ Alkem Laboratories
■ Amgen
■ Apollo Hospitals
■ Apothecaries
■ Aristo
■ Ascho
■ Asian Heart Institute
■ Astra Zeneca
■ Bayer
■ Bombay BioResearch Centre
■ Bombay Hospital
■ Bristol-Myers Sqibb
■ Cadila Healthcare
■ Cardinal
■ CD Pharma
■ Chiltern
■ Chiron
■ Cipla
■ Claris Life Sciences
■ Clininvent
■ Clinirx
■ Clinisearch Biotechnologies
■ Clintec
■ Clintrac
■ Clinworld
■ Cognizant
■ Cogtest
■ Dabur
■ Dharamshila Cancer Hospital
■ Dr. Lal Path Labs
|
■ Dr. Reddys
■ Eisai Pharma
■ Elder Pharma
■ Escorts Heart Institute
■ Excel Life Sciences
■ Fulford
■ Galderma
■ Glaxo
■ Glenmarck
■ Global Spectrum
■ GVK Bio
■ HCL
■ Hinduja Hospital
■ i 3 Research
■ IBM
■ Icon Clinical Research
■ i-Gate
■ Infosys
■ Intas
■ IPCA
■ J & J
■ Jubilant
■ Khandelwal Lab
■ Lambda
■ Lilly
■ Lupin
■ Macleods
■ Manipal Acunova
■ Max Hospital
■ Merck
■ Metropolis
■ Natural Remedies
■ Neeman
■ Nicholas Piramal
■ Novartis
■ Novo Nordisk
■ Nycomed
|
■ Odessey
■ Panacea Biotec
■ Pfizer
■ Pharmanet
■ Quest Diagnostics
■ Quintiles
■ Rajiv Gandhi Cancer Hospital
■ Ranbaxy
■ Reliance
■ Relsys
■ Roche
■ Sanofi Aventis
■ Sciformix
■ Serdia
■ Shreya Life Sciences
■ Siro Clinpharm
■ Solvay
■ SRL Ranbaxy
■ Sun Micro Systems
■ Sun Pharmaceuticals
■ Synchron Research
■ Tata Memorial Hospital
■ TCS (Tata Consultancy Services)
■ Themis Medicare
■ Thinq CRO
■ UCB
■ Unichem
■ USV
■ Vedic Life Sciences
■ Veeda Clinical Research
■ Vital Health Software
■ Wellquest
■ Wipro
■ Wockhardt
■ Xcelerx |
Contact Admission cell :
Greater Noida: Plot no 32-34 Knowledge Park-III Greater Noida UP
Mobile: 9891428828, 9213097541, 9350621054, 9958032288,
Fixline: 0120-3121001/02 Fax: 0120-2323654
New Delhi: C-92, South Extension, Part II, New Delhi
Ph: 011-26262992/3/4, 46191919, 9971333353
Fax: 46191999 |
