Presentation on 'Clinical Trials in India and subsequent opportunities provided by the Indian based Research and Training Organization - Syncorp in India' - Seminar provided @ Tirupati Campus of Syncorp.

1. Presents
Clinical Trials
New Horizon ‟ India

2. Clinical Trials
„ The Way We Make Progress
Against Disease

3. What Are Clinical Trials?
„ Research studies involving
people
„ Try to answer scientific
questions and find better
ways to prevent,
diagnose, or treat disease

4. Why Are Clinical Trials
Important?
„ Clinical trials translate results
of
basic scientific research into
better ways to prevent, diagnose,
or treat disease
„ The more people take part, the
faster we can:

5. SIGNIFICANCE IN INDIA
„ Large patient pool with different types of
diseases
„ Highly skilled and trained clinical research
professionals and doctors
„ Low cost
„ Less stringent regulations when compared
to other regulatory authorities

6. OPPORTUNITIES
Different domains in Clinical Research which
requires qualified and trained individuals
1. Clinical Operations
2. Data Management
3. Pharmacovigilance
4. Medical Writing
5. Regulatory, etc.

7. India Vs US

8. The journey towards becoming an attractive
new destination for clinical research
Attraction Acceleration
1992 1996 2000 2004 2008 2012
61 Companies
Acceptance
100 CROs
80 Hospitals
150 Investigators
registered with US FDA

9. Overall Country attractiveness index :
India 2nd most preferred destination
China 6.10
India 5.58
Russia 5.55
Brazil 5.26
5.00
Czec. Rep.
5.00
U.K.
Argentina 4.90
Poland 4.84
Hungary 4.81
Germany 4.69
South Africa 4.56
Taiwan 4.46
Israel 4.28
Singapore 4.27 Scale : 1-10
Ireland 3.86
United USA 6.88
Patient pool Cost efficiency Regulatory Relevant Infrastructure &
conditions expertise environment

10. CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES
Country All Studies % Industry Sponosred
Australia 1572 62.72
Chinese Taipei 903 45.29
Japan 732 67.76
Korea 674 72.26
China 643 53.50
India 582 72.16
Singapore 335 68.36
Thailand 327 69.42
Chinese Hong Kong 250 82.00
Philippines 206 93.20
Malaysia 180 93.33

11. India : Resource advantages
„ Large No. of specialists in different therapy
segments
Investigators
„ Medical Training In English
„ 600,000 Eng. Speaking physicians
„ Large no. of ICH/GCP compliant Investigators
/ sites
„ Large, Diverse, therapy-naïve
„ Advantage of having 6 out of 7 genetic
Patient
population varieties
„ Large pt. pool in acute/chronic disease
segment
„ Increasing no. of pts in life style disorders

12. India : Resource advantages
• Over 200 Medical Colleges
• Over 22,000 graduates per year
Clinical • 15,622 hosp., 903,952 hosp. beds >75% in urban area
Research • 14000 diagnostic labs
Infrastructure • 700,000 scientists and engineering graduates / year
• World class medical / lab facilities at secondary /
tertiary care centers
• Skilled computer savvy biomedical work force
• Highly developed IT / ITES
IT Support
• Motivated & committed personnel
• High quality digital connectivity
Connectivity • Excellent air/surface transport facilities across
country

13. In conclusion….
Scanty Large
Patient pool
India
Patient Recruitment Highest rate
Lowest rate
rate
India
Speed Low High
India
Most expensive Least expensive
Cost
India
Facility & Smallest pool Highest pool
Investigator pool
India
Industry trial Least experience Most experience
India
experience
Regulatory Least Conducive Most Conducive
Environment India
Quality of data Unacceptable to EU/US Acceptable to EU/US
India

14. International Collaborations
WHO
USA FDA
Health Canada
ANVISA, Brazil
South Africa

15. ABOUT “SYNCORP”
„ SYNCORP!! is a leading Indian
owned Clinical Research Training
and Service Provider. We offer
end to end solutions to the
pharmaceuticals, biotech and
clinical research industries.

16. Syncorp- The Clinical
Research Company
SYNCORP
CR SERVICES ACADEMICS
„ SITE MANAGEMENT „ CLINICAL RESEARCH
„ PATIENT RECRUITMENT TRAINING
1 1
„ SOP DEVELOPMENT „ CLINICAL DATA
„ ETHICS COMMITTEE MANAGEMENT
2 CONSTITUTION 2 „ SAS TRAINING
„ SITE STAFF TRAINING „ MEDICAL WRITING
„ IP STORAGE 3 „ PHARMACOVIGILANCE
3
Authorized
Franchisee
Partner ‟ TN &
AP

17. The CR Industry In
India
 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 $1.5
billion by 2012. Thus, there will soon be a massive
demand for clinical research professionals, making it
an interesting career option with massive growth
potential
 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, including widespread cases of cancer and
diabetes India is viewed the world over as the ideal
location for clinical research

18. How you will be benefited from Syncorp
„ All GCP certified trainers
„ All trainers from reputed Clinical
Research Industry
„ As your choice you can select any course
module
„ Practical oriented class room
programmes
„ Course fees very reasonable & you can
pay in 2 ‟ 3 installments
„ Not required to pay any extra fees for
books, study materials or handouts.
„ Live Clinical Research Project

19. Career
Prospects
Qualified professionals can look forward
towards rewarding careers as
„ Clinical Research Coordinator
„ Clinical Research Associate
„ Data Management
„ Regulatory Affairs
„ QA & QC
„ Pharmacovigilance
„ Medical Writers & many more…………

20. Careers Pathway

21. Cont….

22. Classroom
„
Programmes:
Advance Diploma in Clinical Research
„ Advance Diploma in Clinical Research & Regulatory Affairs
„ Advance Diploma in Clinical Research & Clinical Data Management
„ Post Graduate Diploma in Clinical Research & Pharmacovigilance
„ Post Graduate Diploma in Clinical Research and Clinical Data
Management Including SAS
„ Post Graduate Diploma in Clinical Research and Medical Writing
Some Special Courses
„ Business Management Research
„ Statistical Tools (SAS) in financial sector, market research and
clinical research
„ Eligibility Criteria for the Course
„ MBA/ MCA/ BTech/Mtech/MSc/BSc/Bcom
„ All PG Courses includes Practical Oriented On Job Internship-in
Ongoing Clinical Trials at SYNCORP’s Clinical Sites All Over India

23. Eligibility Criteria for Any Course
„ M.B.B.S/B.D.S/BPharm/M.Pharm/BHM
S/BAMS/BE Biotech/ME
Biotech/Nursing.
„ M.Sc/ B.Sc in Biotechnology ,
Microbiology , Biochemistry,
Genetics or Life Sciences
„ For Medical Writing courses only
Medical Science Graduates/ B.
Pharm / M. Pharm
„ Final Year Interested Students Are

24. CONTACT US @ TIRUPATI
Clincare Institute for Research and Training ‟ A
Division of NIDES™
Authorized Franchisee Partner ‟ Syncorp
1-6-11/C | RS Gardens | Maternity Hospital Road |
Tirupati ‟ 517501
Ph: +91 96760 01317 | +91 96760 01595 | www.nides.in
Email ‟ enquiry@nides.in

25. CDSCO

26. “Let us not follow a path
set by others
Let us set a path for
others to follow”

27. THANK YOU
Clincare Institute for Research and Training ‟
A Division of NIDES™
1-6-11/C | RS Gardens | Maternity Hospital Road
| Tirupati ‟ 517501
www.nides.in
SYNCORP Clincare Technologies (P) Ltd
www.syncorp.in