This document provides an overview of clinical research and related career opportunities. It discusses the objectives of clinical research such as evaluating drug effectiveness and safety. Key areas covered include clinical trials process and phases, roles of various professionals like clinical research associates and project managers, domains like operations and data management. It also highlights India's potential as a hub for clinical research due to its skilled workforce and cost competitiveness. Salary ranges for different roles are provided.

1. Clinical
Research
A Quick
overview

2. OBJECTIVE OF
THIS SEMINAR
To bring together people (Students /
Researchers / Freshers) who wish to
be part of this noble industry for a
better interaction.
To impart basic knowledge about
Clinical Research Industry.
To expose the participants to the
current and future scenarios in Clinical
Research Industry in terms of
Professional Career Opportunities.

3. WHAT IS CLINICAL RESEARCH ?

4. INTERNATIONAL
CLINICAL
RESEARCH DAY
Clinical Trials Day is celebrated
• As recognition of James Lind on May 20th annually.
• To highlight the importance of clinical research in
improving and saving lives.
• It also provides a focal point to raise awareness of
the importance of research to health care and
highlights the critical partnerships between
patients, healthcare practitioners and researchers

5. INTERNATIONAL
CLINICAL
RESEARCH DAY
In the 18th Century, Scurvy was a common ailment for
seamen.
James Lind, a Scottish physician, conducted one of the
first known controlled clinical trials.
Lind found that sailors who ate citrus fruits stayed
healthy.
Captain Cook took Lind’s advice and his crew stayed
healthy for a four year journey
The British Navy then ordered sailors to drink lime juice
James Lind had found the cure for Scurvy – Vitamin C

6. Drug
Development

7. Drug Development

9. CLINICAL
TRIAL
PHASES

10. CLINICAL RESEARCH DOMAINS

11. KEY PLAYERS
IN CLINICAL
RESEARCH

12. CLINICAL OPERATIONS
PROJECT
MANAGEMENT.
SITE
MONITORING.
SITE FEASIBILITY. SITE
IDENTIFICATION
MAINTAIN
QUALITY
SITE
MANAGEMENT
SPONSOR
COORDINATION.

13. ROLES IN CLINICAL OPERATIONS
CLINICL TRIAL
ASSOCIATE
• Administrative
roles or clinical
trial
administrators
who support the
day-to-day
activities for the
trial
CLINICAL RESEARCH
ASSOCIATE
• Field-based
monitors or
clinical research
associates who
travel to different
research units to
ensure the trial is
running correctly.
CLINICAL PROJECT
MANAGERS
• Clinical
study/project
managers who
manage the
teams or running
of the trial
(usually on a
region or global
level)
PROJECT DIRECTOR
• Directorship
roles where the
person will have
the sole
responsibility for
a trial.

14. SALARY RANGE IN CLINCAL OPERATIONS

15. CLINICAL DATA MANAGEMENT
AND
BIOSTATISTICS

16. Why do the pharmaceutical
companies conduct clinical trials?
To get the approval for the new drug from the regulatory
authorities
How do they get the Approval?
By providing the evidences in the form data
Hence the data collected in a clinical trial has to be reliable, of high quality
and statistically sound

17. What is Clinical
Data
Management
• Clinical data management
(CDM) is a process of
collection, cleaning and
management of subject data in
compliance with regulatory
standards.
• The objective of CDM
processes is to provide high-
quality data by eliminating
mistakes and accumulating the
most data possible for analysis.

18. CDM Process
CRF Designing
Database Designing and Programming
Database Validation
Data Collection and Entry
Loading the External Data

19. Medical Coding
Data Review
SAE Reconciliation
Database Lock and archival
Statistical Analysis and Report writing
CDM Process

20. Roles in CDM Project
Data
Manager
CRF
Designer
Database
Developer
Data Entry
Operator
Data
Manger
Medical
Coder
Biostatistici
an
Statistical
Programme
r

21. • Servers as Sponsor POC
• Co-ordinates with the internal team
• Generates the study plans
• Reviews and approves the
documents generated for the study
• Manages the study timelines,
budget and deliverables
• Ensures the smooth conduct of the
DM activities
Project
Data
Manager

22. • Design the CRF as per the
study protocol
CRF
Designer
 Designs the study database as
per the final CRF
 Program the validation checks
 Performs External Data loads
Database
Developer

23. • Responsible for performing the data
entry of the received CRFs
• Tracking and Indexing of received CRFs
• Performs quality check of the entered
data
 Performs medical coding as per
the coding dictionaries
 Responsible for medical review
on the crtitical data
Data
Entry
Operator
Medical
Coder

24. • Performs database validation and UAT
• Preparation validation documents
• Responsible for data review
• Performs SAE reconciliation
• Performs Lab data reconciliation
Data
Manger

25. • Provides inputs in the protocol pertaining
to the statistical analysis
• Calculates sample size and generates
randomization
• Prepares the statistical analysis plan and report
Biostatistician
 Responsible for programming
of study datasets and
generation of TLFs
Statistical
Programmer

26. Tools used in DCM
CRF Designing
• Microsoft office
- word
• Adobe InDesign
• Adobe
FrameMaker
Clinical
Databases
• Medidata RAVE
• InForm
• Oracle Clinical -
RDC
Statistical
Analysis
• SAS
• IBM-SPSS
• R

27. Qualifications required
Data Manager
• Science/ Life science graduate/post graduate
• Pharmacy Graduates
Database Developer
• Bsc/Msc IT,
• Science graduate with programming knowledge
Medical Coder
• Pharmacy Graduates/ Post graduates
• BAMS/ BHMS

28. Qualifications required
Biostatistician
• Graduate/post graduate in statistics
• Doctorate in statistics
Statistical Programmer
• Bsc/Msc IT, BE
• Certification in statistical applications
such as SAS

29. Added Advantage
Data Management
• CCDM (Certified clinical data
manger by SCDM)
Statistics
• Base / Advance SAS
certification

30. India as a Hub for Clinical Trials
Diverse talent pool with a large number of healthcare
professionals
Skilled professionals in the field of IT and other sciences
Cost competitiveness
A huge patient pool

31. SALARY RANGE

32. Medical and
Scientific Writing

33. What is medical writing all about?
“Medical writing is the activity of writing
scientific documentation by someone
who is a specialized writer (a medical
writer) and is generally not one of the
scientists or doctors whose research it
was.”

34. Types of
Medical &
Scientific
Writing
Science Journalism
Technical Writing/Editing
Marketing
Medical Writing

35. Science Journalism
 Science, health, or
medical beat reporters
for a newspaper
 Staff writers for
magazines (eg
Newsweek)
 Freelance writers
specializing in science
topics

36. Technical Writing and Editing
 Generally, work for pharmaceutical or biotech
 NDA/IND filing
 Computer
 Electronics
 Protocol development for Scientists/Physicians
 Technical guides/instructions
 Product specifications
 Journal/textbook editing

37. Marketing
 Most pharmaceutical and biotech companies
have marketing departments
 Press releases
 Web site content
 Advertisements
 Catalogs
 Other marketing materials

38. Employers

39. Opportunities Within the
Pharmaceutical Industry
• Scientific communications
• Manage publications plans
• Develop manuscripts, abstracts, posters
• Medical education
• Medical promotion
• Regulatory
• Develop clinical study reports (CSR)
• Develop Study Protocols
• Write new drug application (NDA)
documents
• Support preparations for FDA meetings
such as advisory committee meetings
(ACM)

40. Qualifications
Attention to detail -
thorough and
accurate
Good
communication
skills (written and
verbal)
Ability to write well
and tailor
information to
specific audiences
Clear, concise
Logical story flow
Ability to work with
team members of
diverse educational
backgrounds
Ability to work
independently
(often remotely)
Deadline oriented
Good organization
and management
skills

41. Education and Training
• Education level parallels job requirements
• Bachelor of Science/Pharmacy or Master of
Science/Pharmacy
• BDS
• MBBS
• PhD
• B Pharm
• M Pharm
• PharmD
• MD
• Excellent software skills
• May require testing or additional training

42. Why Consider A Career In
Medical Writing?
• Work is engaging
• Diverse exposure to therapeutic
areas
• Cutting edge drug development
• Lucrative and in high demand

43. SALARY RANGE

44. PHARMACOVIGILANCE

45. What is
Pharmacovigilance?

47. Terms commonly used in drug
safety
• Benefits are commonly expressed as the proven therapeutic
good of a product, but should also include the patient’s
subjective assessment of its effects
• Risk is the probability of harm being caused, usually
expressed as a percent or ratio of the treated population; the
probability of an occurrence

48. Terms commonly used in drug
safety
• Harm is the nature and extent of the actual damage that
could be caused. It should not be confused with risk
• Effectiveness is used to express the extent to which a drug
works under real world circumstances, i.e., clinical practice
(not clinical trials).
• Efficacy is used to express the extent to which a drug works
under ideal circumstances (i.e., in clinical trials)

49. Objectives
• Short-term objectives – To foster a culture of
notification
• Medium-term objectives – To engage several
healthcare professionals and NGOs in the drug
monitoring and information dissemination
processes
• Long-term objectives – To achieve such
operational efficiencies that would make Indian
National Pharmacovigilance Programme a
benchmark for global drug monitoring
endeavors

50. CAREERS IN PHARMACOVIGILENCE
50
Drug Safety Associate
• Entry level job in
Pharmacovigilance
Mainly involved in case
creation data entry of all
information available in the
document
Reconciliation, checking for
minimum safety information
and follow-up process
Drug Safety Scientist
• Required complete
knowledge about medical
coding, good understanding
medial terms and common
understanding regulatory
affairs.
• Make sure that their
pharmaceutical products are
effective and safe.
• Responsible for identifying
and reporting on the adverse
effects of drugs
Aggregate Report Scientist
• Compilation of the safety data
for a drug over a prolonged
period.
• Require good narrative
writing experience of
individual cases like writing of
PSUR and PADER.

51. SALARY RANGE
51

52. CERTIFICATION IN
CLINICAL RESEARCH
MONITORING
CERTIFICATION IN
CLINICAL DATA
MANAGEMENT
CERTIFICATION IN
MEDICAL WRITING
CERTIFCATION IN
STATISTICAL
PROGRAMMING
CERTIFICATION IN
PHARMACOVIGILANCE
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