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

O h Si S ffOther Site Staff

CRO

Demand

Sponsor

Demand Supply

Invigilator

0 2000 4000 6000 8000

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

PATIENTPATIENT

CHALLENGES

HOSPITALS

DATA CAPTUR

E

STAFF

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

Law/ActLaw/Act

Governance

Hospitals

Workforce

PatientPatient