PRIYADARSHINI ARAMBAM Chief Clinical Research & Ethics Coordinator Academics & Research Department Fortis Escorts Heart Institute Okhla Road,New Delhi-110025 (INDIA)
PRIYADARSHINI ARAMBAMChief Clinical Research & Ethics Coordinator
Academics & Research DepartmentFortis Escorts Heart Institute
Okhla Road,New Delhi-110025 (INDIA)
Phlebotomist Laboratory technician Laboratory technician OT technician
EMT A Fortis has pioneered to commence this EMT-A – Fortis has pioneered to commence this course in association with University of Utah, USAUSA
Paramedics involved in Clinical Research Paramedics involved in Clinical Research Nurse
Ph i i i t t Physician assistant
Total strength of FHL :75 hospitalsTotal strength of FHL :75 hospitalsBEDS : ~ 12,000 D t 5000Doctors : 5000 Primary care centres : 580 Day care speciality centres : 191 Diagnostic centres : 210 gTalent pool : 23,000peopleClinical Research trials : 123Clinical Research trials : 123
Workforce % ( Drs: Nurses: Others) : 12:36:52( )
Accreditations :
JCI / NABH/NABL
Large Patient Pool/GCP
Central clinical
research ool GC Doctors research
centre
FHL Central & U it Ethi
Dedicated Stem cell Unit Ethic
CommitteeStem cell research
centre
Cardio:50%, Gastro:20%, Onco:10%
Met.Dis.:10%
Bioequivalence centre
(FCRL)Other
Spec.:10%
Source: IndiPharm projections based on information fromThe Boston Consulting Group and Business Communications Co.
Growth of Indian Clinical Trial Industry
1200 1000
800
1000
1200
lion)
120 160300400
600
USD
(Mill
35120
0
200
2002 - 03 2005 - 06 2006 - 07 2007 - 08 2009 - 2010
U
YearAs per FICCI - Ernst & Young Survey Report 2008, India can attract between 5 - 10% of the global contract research outsourced market (all services including chemistry, toxicology and clinical research) over next 5 years.
• ~ 300 Medical Colleges
• 15,622 hospitals Medical , p
• 903,952 hosp. beds Medical College
•14000 diagnostic labs Diagnostic •14000 diagnostic labs DiagnosticLabs
• 600,000 Medical professionals 700 000 i ti t d i i d t Medical
Professional
• 700,000 scientists and engineering graduates • 500,000 nursing, paramedic and support staff
CDSCO
“India: The clinical research hub."
Q Cost –efficient
Q High quality
Globally Diverse patient Globally recognized
Diverse patient pool
Indian pharmaceutical
industrySelf-sufficient Infrastructure and industrySelf-sufficient environment
Very less involvement of nurses and physician due to lack of awareness
The involvements are driven by chances and not by choices
Few teaching institutes, only one dedicated institute exclusively teaching clinical research course (ICRI)
Still get absorbed as Clinical research nurse without the certifications
Historical Background , Political Influence & Strategies
Policy Development
EC – its role & remittance of docs
Principles and practice of Informed consent process
P f i l K l dg & Skill t f ilit t ffi i t fProfessional Knowledge & Skill to facilitate efficient, safeand participants focused
Data Handling –Collection, Storage & Completion
Facilitate good delivery of clinical research Facilitate good delivery of clinical research