Clinwell Kriger in Pharmacy....

1. CLINICAL RESEARCH
BY
Clinwell Kriger Training & Research Institute
Agra

2. WHAT’S NEXT
?

3. PHARMACY CAREERS
M.Pharmacy PhD
B.Pharmacy
2yrs 3 - 4yrs
MR Industry Industry Lecturer Professor
8-10,000/- 6,000/- 12,000/- 15-16,000/- 30 – 35,000 /-
2yrs 2yrs 2yrs
Area manager 12-15,000/- 18-20,000/-
18-20,000/-
Drug inspector -15,000/-
GOVERNMENT
Pharmacist- 10,000/-

4. WHAT IS CLINICAL RESEARCH?
systematic study of safety & efficacy of a new
pharmaceutical product (drug or device)when it is
first time introduced into humans.
• It includes the study of a
- New Drug
- New Disease
- New Technology

5. ENTRY OF A NEW DRUG IN TO MARKET
1. New drug development
2. Preclinical testing/ animal studies
3. IND application filed with FDA
4. Clinical trials (phases 1, 2, and 3)
5. NDA filed with FDA
6. FDA validates and approves drug
7. Phase 4

6. DRUG DEVELOPMENT PROCESS

7. PHARMACIST ROLE
IN
CLINICAL RESEARCH

8. CAREER GROWTH IN CLINICAL
RESEARCH
BIOSTATICIAN
PROJECT MANAGER
75-80,000/-
80-90,000/-
CRA-II
35-40,000/-
DATAMANAGER
45-50,000/-
CRA-I
25,000/-
CRC DATA ENTRY OPERATOR
15-16,000/- 18-20,000/-

9. SPECIALLY FOR PHARMACY FIELD
PHARMACO VIGILANCE AUDITOR
30-40,000/- 50-60,000/-
REGULATORY OFFICER RESEARCH OFFICER
40-50,000/- 1-2 LAKHS / MONTH
SAFETY LEAD (Drug Safety Specialist)
35-40,000/-

10. •CLINICAL RESEARCH
Clinical research is a scientific study of
the effects, risks, efficacy and benefits
of a medicinal product. These are
carried out prior to the release of the
medicine in the market.
Clinical Research is a systematic study
for new drugs in human subjects to
generate data for discovering or
verifying the Clinical, Pharmacological
(including pharmacodynamics and
pharmacokinetic) or adverse effects with
the objective of determining
safety and efficacy of the new drug.
These trials are undertaken at various
stages and studies are conducted after
the launch of a new product to
monitor safety and side effects during
large-scale use.

11. CLINICAL RESEARCH-INDIA
• India has the largest pool of patients(e.g. the highest number
of cancer and diabetes patients are found in India)
• Highly qualified Physicians and Surgeons
• Availability of Medical, Pharmacy and Science graduates
• Comparative cost advantage
• At present more than 1500 trials going on in India and 4000
trials were registered in 2010

12. JOB OPPORTUNITIES IN CLINICAL
RESEARCH
 PHARMA COMPANIES : 325 YEARLY REQUIREMENT
 BIOTECH COMPANIES : 240 OF CR PROFESSIONALS
 CRO’S : 100 >50,000
 MNC’S : 50
 GROWTH RATE IN CLINICAL RESEARCH IN INDIA – 30%
 WITHIN TWO YEARS GOVERNMENT SECTOR IS COMING
ABROAD
 55,000 CLINICAL TRIALS IN USA
GROWTH RATE IN CLINICAL RESEARCH IN ABROAD – 55%

13. • Clinwell kriger training and research institute
• Collaboration with Clinwell Research Inc. and
Kriger Research Center
• Site management organization
• Independent ethics committee
• Current trials: Phase III trial [cardiac]
Phase IV trial [skin burns]

14. WHY CKTRI ?
 Classroom teaching with direct contact with
faculty and staff.
 Online session for convenient off-hours
usage.
 Hands-on training with live projects.
 Internship opportunities.
 PG Diploma has worldwide recognition in the
bio-pharmaceutical industry.
 Our courses are recognized by IBPA, ACRP,
APPI and SOCRA.
 We have an active job placement department
to which all student will have access upon
completion.

15. •FULL TIME TRAINING

16. •WEEKEND TRAINING
Courses Duration
• Advance Certification Program in Clinical Research 6 months
• Advance Certification Program in Clinical Data Management 6 months
•ONLINE TRAINING
• Advance Certification Program in Clinical Research 3 months
• Advance Certification Program in Clinical Data Management 3 months
• Advance Certification Program in Pharmacovigilance and 3 months
Regulatory Affairs

17. OUR COURSES
Clinical Research Associate + GCP Certificate
Eligibility:
Life Science (B. Sc.), MBBS, BDS ,BAMS, BHMS, B.Pharma, B.PT.,
B.Sc. & B.tech Biotech
M.Sc. In Clinical Research + GCP Certificate
Eligibility:
Life Science (B. Sc.), MBBS, BDS ,BAMS, BHMS, B.Pharma, B.PT., B.Sc. &
B.tech Biotech
Data Management Program + GCP Certificate
Eligibility:
Life Science (Graduates), MBBS, BAMS, BHMS, B.Pharma, BDS, B.PT,
and IT background
Quality Assurance Program + GCP, GMP, GLP Certificates
Eligibility:
B. Sc., BAMS, BHMS, B.Pharma, BDS, B.PT,B.tech
Biotech

18. CONTACT US
USA Of fice:
15 Corporate Place South,
Suite 333,Piscataway,
New Jersey 08854
Email: info@clinwellresearch.com
AGRA CAMPUS:
3 H R Estate, Bodla-Bichpuri Road, Agra-282010.India
Phone: 0562-6540228
Mobile: 9639008511, 9639008512
Web: www.cktri.org
Email: cktri.agra@gmail.org