Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development

1. Clinical Research Industry
&
Opportunities in CR

2. 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

3. Clinical Research
RESEARCH
DRUGS BIOLOGICS MED. DEVICES
– To test its
– Efficiency
– Efficacy
– Toxicity BEFORE MANUFACTURING AND MARKETING

4. The Pharmaceutical Enterprise
Discovery Pre-clinical Clinical
CMC
Labeling (Chemistry, Mfg, &
Regulatory Control)
Manufacturing
Sales & Marketing Safety &
Surveillance

5. New Drug Development is...
500 Million US $(235)
Expensive
Time consuming 12 years
Cumbersome 1 out of 10,000 NCE
becomes a marketable drug
… and what will the Marketing outcome be?

6. Compound Success Rates by Stage
Years
0 5,000–10,000
Discovery Screened
(2-10 Years)
2
Preclinical Testing
250
Laboratory and Enter Preclinical Testing
4 Animal Testing
6
Phase I 5
20-80 Healthy Volunteers Enter
Used to Determine Safety 8 Phase II
100-300 Patient Volunteers
Clinical
And Dosage
Used to Look for Efficacy Testing
10 and Side Effects
Phase III
1,000-5,000 Patient
Volunteers Used to 12
Monitor Adverse Reactions 1
to Long-term Use Approved
14 FDA Review/Approval
by the FDA
Additional
Post-marketing 16
Testing
Source: Tufts Center for the Study of Drug Development

7. PHARMA- THE R&D PIPELINE
• IND - Investigational New Drug Application Production
• NDA - New Drug Application &
Marketing

8. Stake Holders in Clinical Research
– Pharmaceutical companies
– R&D department
– Contract/ Clinical Research Organizations
– Clinical research managers
– Research coordinators
– Regulatory affairs managers
– Data managers
– Medical writers
– DCGI
– Ethics committee
– Hospitals
– Accredited laboratories
– Doctors ( Clinicians)

9. Job positions in Clinical Research
– Entry level
• Clinical Research Coordinator
• Business Development Executive(BDE)
• Regulatory Affairs Executive(RAE)
• Co- Investigator
• Drug Safety Associate
– Middle level
• Clinical Research Associate (CRA)
• Study Coordinator
• Investigator
– Senior level
• Director Projects
• Director Clinical Research
• Data Manager
• Director Regulatory Affairs

10. Who are involved in the process of
Clinical research?
• Pharmaceutical Companies - Sponsors of the trial
• CRO - Implementers of trial
• Drugs - Objects of the trial
• Patients/ Volunteers - Subjects of the trial
• Doctors - Investigators in the trial
• Clinical Research Managers - Manage the trial
• DCGI - Regulatory Authority of the trial
• IEC - Monitors compliance of ethics
• Hospital - Site of the trial
• Accredited Laboratories - Lab Investigation of the trial
• Regulatory Affairs Managers - Ensures compliance of regulatory
Guidelines
• Data Managers - Develops Statistical Models &
Methodology for Clinical Studies
• Medical Writers - Develops the Study Documents,
Reports & Publications

11. Mc Kinsey Reports on Clinical
Research
• “India will need over 50,000 Clinical
Research Professionals & Globally
250,000 Clinical Research
Professionals by 2012”
• “The global clinical trial outsourcing
opportunity to India is expected to
grow to Rs.5,000 crores by 2010”

12. Exponential Growth of CR industry
GROWTH OF THE
CLINICAL
2003: Rs. 100 Cr
RESEARCH 2004: Rs. 250 Cr
INDUSTRY 2010: Rs. 5000 Cr
McKinsey Report (50 times)

13. Opportunities for CR professionals
• Starting salaries are expected
to range from Rs.15,000 -
Rs.20,000/ month onwards
depending on the basic
qualification & experience
• At 30 years one could be a
Director – Operations /
Regulatory Affairs, earning a
salary of Rs.1 Lakh per month

14. Average Salaries for CR
professionals
Country Average Salary for 1 to 2 year
experienced CR professionals
USA USD 5000 / month
Canada CDN 3500/ month
UK GBP 1500 – 1800/month
India INR 15,000 - 20,000/month

15. 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.
World wide vacant positions estimated to be 250,000 by year 2010

16. Advantage - India
• India signatory to TRIPS
• New Patent Law since April 2005
• Clinical trials - mandatory for new drugs
• Clinical trials - to be based on ICH-GCP norms
• Patient enrollment – the key advantage
• Tax concession for R&D expenditure
by Govt. of India consistent with WTO guidelines
• Clinical research spending in India to increase by 30%
(5000 Crores) annually through 2010

17. 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)

18. Pharmaceutical companies & CROs
in India

19. Your Pathway to
Clinical Research Industry

20. CR Industry is looking for
• Qualified, Competent & Committed people
• Professionals with relevant education &
experience
• Hands on experience
• Good Communication Skills
• ATTITUDE

21. Industry is in search of……………..
Relevant
Education
Relevant
Experience
Professional

22. Clinical Research
Administration/Management
VIII. ENGLISH I.
LITERATURE PHARMACOLOGY
II. MEDICINE
VII. BIOSTATISTICS
CRM
VI. III. NURSING
INFORMATION
TECHNOLOGY
V. MANAGEMENT IV. LAW

23. Head
Medical Quality Other CR Project Biometry
Regulatory
Services Mgmt
Medical Auditor Data Mgt
Finance Project
advisor manager
Quality Study Statistics
Human
Medical control Mgr
Res
monitor Clinical Medial
Training Team writing
Trial Leader
Pharmaco- supplies
vigilance
Sr CRAs
CRAs
CRCs

24. Basic Qualification required to enter the
CR Industry
Career Fields Qualification
MSc Biochemistry,
Clinical Research Btech Biotechnology,
MSc Microbiology
Management
MSc Zoology
BSc Nursing, MSc Nursing
Pharmacovigilance Doctors (MBBS, BDS, BAMS, BVMS)
B Pharm, M Pharm
MCA, B Tech Computer Science
Clinical Data Management/ MSc Computer Science, MSc
Bioinformatics
Biostatistics MSc Mathematics, MSc Statistics
MSc Biostatistics

25. Way Forward
• Research Aptitude Test (Aptitude/
Interest)
• Academic/ Industry Evaluation
(Employability)
• Internships with Stipends
• Training with scholarships

26. Research Aptitude Test Evaluation

27. Reference Books & Internet
1. All that you wanted to know about Clinical
Research
By Samir Malhotra MD, DM/ Nusrat Shafiq MD, DM/
Promila Pandhi MD/DM- PGIMER, Chandigarh, India)
2. Death By Prescription , Magna Books
By Dr Ray D Strand, MD
www.wikipedia.org/wiki/Clinical_research
http://www.accenture.com/careers
http://www.novartis.com/careers/index.shtml
http://www.ppdi.com/careers

28. There is a no
punishment for
asking
Questions!!!

29. Q&A
Thank you