Clinical research involves systematically studying new drugs in human subjects to discover and verify their safety, efficacy, clinical effects, and adverse reactions. Careers in clinical research include clinical research associate, clinical research coordinator, clinical investigator, medical advisor, biostatistician, data manager, clinical trial auditor, medical writer, and clinical research trainer. Clinical research work involves clinical trial processes and operations, clinical data management, medical writing, pharmacovigilance, regulatory affairs, and quality assurance.

1. CLINICAL RESEARCH
DR G A WAGHMARE

2. Clinical research
Clinical Research / Clinical Trials is a
systematic study for new drugs in human
subjects.
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3. It generates data for discovering and verifying
the Clinical, pharmacological (including
pharmacodynamic and pharmacokinetic) and
adverse effects with the objective of determining
safety and efficacy of the new drug.
What is Clinical Research?

4. CLINICAL RESEARCH
THE CAREER OF THE FUTURE

5. Career Prospects in Clinical Research
Career
prospects
CRA
Clinical Trials Auditor
Data Manager
Clinical Research
Investigator
Drug safety
Associate
Regulatory Affairs Manager
Medical Writer
Study
Coordinator

6. Careers in Clinical Research Industry
 Clinical Research Associate
 Clinical Research Coordinator
 Clinical Research Investigator
 Medical Advisor
 Biostatistician
 Data Manager
 Clinical Trial auditor
 Patent Officer
 Medical writer
 Clinical Research Trainer

7. Domains in Clinical Research:
Clinical trial Processes/ Operations
Clinical Data Management
Medical Writing
Pharmacovigilance
Regulatory
Quality Assurance
Business Development

8. Clinical Trial Processes/ Operations

9. Clinical Trial Processes/ Operations
 Phase I - (Human/clinical pharmacology
trials)
 Phase II - (Exploratory Trials )
 Phase III - (Confirmatory trials )
 Phase IV - (Post marketing surveillance )

10. Data Management & Statistics
in Clinical Research

11. CDM - Overview

12. CLINICAL DATA MANAGEMENT (CDM)
 CDM is the process of
ensuring that data collected
during the course of a clinical
trial is:
 Accurate
 Complete
 Logical
 Consistent
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13. Careers in Clinical Data Management
 Data Entry Field
- different levels
 Validation Field
 Discrepancy Management
 Coding
 Safety reporting

14. Medical Writing

15. Medical Writing
If you have…..
 A flair for writing
 Medical writing
Research related writing
Medico-marketing related
 A marketing inclination
 Medico-marketing in the pharma industry
 Technological inclination
 Medico-technical opportunities

16. Medical writers
Medical communication
agencies
Pharma. companies
Clinical research
organizations
Scientific press
Advertising agencies
Freelancers

17. Medical writers have different
backgrounds
 Science Graduates
 PhD
 Pharmacy
 Medicine
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18. Other Career Opportunities
Pharmacovigilance
Regulatory
Quality Assurance
Business Development

19. Careers in Pharmacovigilance
Drug safety Coordinator
Drug safety Associate
Drug safety Manager
Medical Advisor

20. Regulatory
 Indian Regulatory
 Ministry Of Health & Family Welfare
 Drugs Controller General of India (DCGI)
 CDSCO (Central Drugs Standard Control
Organization)
 Schedule Y of Drug and Cosmetic Act 1940
 United States Food and Drug Administration
(USFDA)
 EMEA
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21. Quality Assurance and Quality Audit
 Quality: the total set of characteristics of a product
or service that affect its ability to satisfy a
customer's stated or implied needs
 Quality system: the organizational structure,
responsibilities, procedures, processes, and
resources for implementing quality management
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