This document provides an overview of clinical research and career opportunities in the field. It defines clinical research as organized studies conducted on humans to evaluate the safety and efficacy of drugs, medical devices, and other therapies. Various types of clinical research are described. The document outlines the clinical research process and regulations, and notes the growth of the industry in India. Career opportunities are discussed for various roles in clinical research organizations, pharmaceutical companies, and other settings. Requirements and top cities for clinical research in India are also summarized.

1. CLINICAL
RESEARCH AND
CAREER
OPPORTUNITIES

3. CLINICAL RESEARCH - AN OVERVIEW
 What is Clinical Research?
• Is an organized research conducted on human
beings
• Intended to provide adequate information on the use
of drugs as a therapeutic agent, with regard to
_ Usefulness
_ Safety
_ Adverse effects

4. CLINICAL RESEARCH

-- To Test its
- Safety
- Efficacy
- Toxicity Before Manufacturing And Markeing
RESEARCH
DRUGS BIOLOGICS
MED.
DEVICES

5. THE PHARMACEUTICAL ENTERPRISE

7. NEW DRUG DEVELOPMENT IS…

8. TYPES OF CLINICAL RESEARCH
Treatment research
Prevention research
Diagnostic research
Screening research
Quality of life research
Genetic studies
Epidemiological studies

9. REGULATIONS & GUIDELINES
 Drugs and cosmetic act
Schedule Y
 Indian GCP guidelines
 Clinical Trial Permission
 Import License
 BA BE Guidelines
 ICMR Guidelines for Medical Ethics
 ICH GCP Guidelines
 USFDA
 EU Directives

10. CLINICAL RESEARCH –
EARLIER(LATE 1990)
 Clinical research is a relatively new business
and profession in INDIA
 During the previous decade, not even a single
contract research organization (C.R.O) existed
in india.
 Pharmaceutical companies who were doing
clinical trials managed regulatory work on their
own and used to run the trial on their shoulders.
 Only a handful of senior doctors represented
participating in global multi-centric study

12. MARKET SCENARIO-WORLDWIDE
 Internationally, the demand for clinical research
specialists is even stronger than in india. The
shortage globally traverses all continents
including most notably North America, Europe,
as well as Asia, Most EU, Canadian, and US
employers are outsourcing the majority of the
clinical research work to india.
 These employers from the US, EU and Canada,
though, have thousands of jobs available
across India, which has become one of the
world’s leading centers for clinical research.

13. ADVANTAGE - INDIA
 Large and diverse patient pool
 Availability of Medical, Pharmacy / Science
graduates
 Highly developed IT Industry
 English speaking Medical / Research
professionals
 Higher prevalence of diseases
 Comparative cost advantages
 Changes in patent law w.e.f April 2005
( product based patency V/S procedures based
patency)

14. CLINICAL TRIAL APPROVALS AS PER CDSCO

15. DEMAND SUPPLY GAP IN INDIA
0 1 2 3 4 5
SPONSOR STAFF
CRO STAFF
INVESTIGATOR
OTHER SITE STAFF
Column1
DEMAND
SUPPLY

16. WHO ARE INVOLVED IN THE PROCESS OF
CLINICAL RESEARCH?
• Pharmaceutical companies
• CRO
• Drugs
• Patients/ Volunteers
• Doctors
• Clinical Research Mangers
• DCGI
• IEC
• Hospital
• Accredited Laboratories
• Regulatory Affairs
Managers
• Data Managers
• Medical Writers
 Sponsors of the trial
 Implements of trial
 Objects of the trial
 Subjects of the trial
 Investigators in the trial
 Manage the trial
 Regulatory Authority of the trial
 Monitors compliance of ethics
 Site of the trial
 Lab Investigation of the trial
 Ensure Compliance of regulatory
Guidelines
 Develops Statistics Models &
Methodology for clinical studies
 Develops the study documents,
reports & publications

17. CR CAREER PATHWAY
 Pharmaceutical companies
 Clinical CROs ( Contract Research Organizations)
 BA/BE Centers
 SMOs (Site Management Organizations)
 Data Management CROs
 IT Companies in Healthcare / Clinical Domain
 EDC Service providers
 Central Laboratories
 Packaging & Labeling & Contract Manufactures
 Investigator & Site Staff
 Training Centers.

18. BASIC QUALIFICATION REQUIRED TO ENTER
THE CR INDUSTRY
CLINICAL RESEARCH
MANAGEMENT
MSc Biochemistry
Btech Biotechnology
MSc Microbiology
MSc Zoology
PHARMACOVIGILANCE
BSc Nursing, MSc Nursing
Doctors ( MBBS, BDS, BAMS,
BVMS)
B Pharm, M Pharm
CLINICAL DATA MANAGEMENT/
BIOSTATICS
MCA, B Tech Computer
Science
MSc Computer Science, MSc
Bioinformatics
MSc Mathematics, MSc
Statistics
MSc Biostatistics

19. CAREER IN CROS / PHARMA / BIOTECH
COMPANIES
 Clinical Trial Assisstant (CTA)
 Clinical Research Associate (CRA)
 Senior CRA
 Clinical Team Leader
 Project Manager
 Senior Project Manager
 Manager Medical & Regulatory
 Manager-Safety / patents
 Manager Quality Assurance
 Medical Director
 Associate Director- Clinical
 Associate Director- Projects
 Director –Business Development
 Director / Head (clinical operations)
 General Manager / CEO / President
Phase 1 / 2 / 3 / 4 Trial
Project Management
Drug Development
Planning
Monitoring
Source Data Verification
Safety Reporting
Regulatory Approval
QA Audits
Business Development

20. CAREER IN SMO
 Clinical Research Coordinators (CRC) / Study
Coordinators
 Principal Investigators / Co-Investigators
 Medical Monitors
 Project Manager / Senior Project Manager
 Manager Medical & Regulatory
 Manager Quality Assurance
 Manager –Business Development
 Medical Director
 Associate Director _ Clinical
 Associate Director _ projects
 Director / Head ( Clinical Operations)
 General Manager / CEO / president

21. CAREER OPPORTUNITIES IN DM
 Data Entry operator
 Data Validation Executive
 QA Executive
 Data Manager
 Statistical Programmer
 Statistician
 Data Reviewer
 Data Base Designer
 Medical Writer
 Head –Data Management

22. OPPORTUNITIES FOR CR PROFESSIONALS
 Tremendous career
opportunities in the industry
 Lucrative salaries
 Excellent growth prospects
 International exposure and
prospects

23. KEY ORGANIZATION INTO THIS AREA
 Companies into clinical research sponsor companies :
johnson & johnson, Bicon, Glaxosmithkline Beecham,
Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas
piramal, Dr. Reddys Laboratories, Novo Nordisk, Pflizer etc.
 CROs : Quintilies, Manipal Acunova, ICON International,
Clintec, Clinigene Internation, Accentureal, Paraxel, Asian
clinical trials, Paragon, etc
 Hospitals : st.johns Hospital, MS Ramiah Memorial Hospital,
Kidwai Hospital, Workhard Hospital, Apollo Hospitals etc.

24. KEY CITIES IN INDIA FOR CLINICAL
RESEARCH
• Delhi & NCR Region
• Mumbai
• Pune
• Ahmedabad
• Vadodara
• Hyderbad
• Bangalore
• Chennai
 There are some new cities like Chandigarh; Bhopal,
Indore, Coimbatore; Vizag are emerging as new
centers for clinical trials

25. KNOWLEDGE
Basic Knowledge
 Drugs Development Process
 Clinical Trial Design & Statistics
 Adverse Events & Toxicology
 Regulatory & Ethics (GCP, GMP, GLP)
 Pharmacy, Pharmacokinetics, Pharamacology
 Disease, Diagnosis, Drugs
 Information Technology, Computing Skills

26. ROLE OF TRAINING
 Every player in clinical research is expected to be
a responsible and commited manager.
 Training in clinical research to a great extent
helps to build up most of these qualities and
developed an insight into the field.
 However, it always depends upon the quality and
the methodology of training and trainers’
experience in the field.

27. ROLE OF TRAINING(CONT…)
 A good training will ensure that at the end of the
course the student is able to take up responsibilites
in the industry without further training by the
employer where he would be eventually placed.
 Hence it is not sufficient to have an ambition to do a
course clinical research but also to choose the right
institution.