Clinical Research is a scientific study of the effects, risks,

efficacy and benefits of a medicine. They are undertaken at

various stages also known as 'phases', and include: trials on
healthy humans; trials on patients with a disease; and studies
conducted after the launch of a new product (PMS) to monitor
safety and side effects during large-scale use.

Clinical trials are conducted by pharmaceutical companies or

Contract Research Organization (CRO’s) / Site Management
Organization (SMO’s) on their behalf. It is this sector that is
driving the growth in Clinical Research in India.
 PHASE I

PHASE II

PHASE III

MARKETING OF THE DRUG

POST MARKETING SURVEILLANCE

OR PERIODIC SAFETY UPDATE REVIEW

PHASE I – HUMAN PHARMACOLOGY TRIALS

PHASE II – THERAPEUTIC EXPLORATORY TRIALS
PHASE III – THERAPEUTIC CONFIRMATORY TRIALS
MARKETING OF THE DRUG
PHASE IV – POST MARKETING SURVEILLANCE /
PERIODIC SAFETY UPDATE REVIEWS
The total worldwide R&D spending for pharmaceutical and
biotech companies (Pharma) in 2007 was $117 Billion, of which
70% represented development costs. This spending is expected
to grow at 11% annually and will be $218 billion in 2013.
The CRO market for Phase 1 through 4 trials represented about
$7.8 Billion in 2007 and is projected to grow to $17.2 Billion in
2013.
Clinical Trials.gov currently has 86,860 trials with locations in 172
countries.
Continue to spread in more & more countries.
Six therapy areas, oncology, central nervous system,
respiratory, endocrinology, cardiovascular and infectious
diseases, account for 68% of all clinical trial protocols and 74%
of all sites analyzed.
India is home to more than one billion people.
India has a population of appx. 30 million with cardiovascular
diseases , 25 million with type – 2 diabetes and 10 million with
major psychiatric disorders.
India is one of the top 3 countries where companies plan to
spend the most R & D dollars over the next 3 years.
India’s pharmaceutical industry is the second largest in Asia,
growing by 9% annually.
Excellent quality management, Technology and infrastructure
available in India.
Over 200 hospitals serving as sites for clinical trials, India is
emerging as one of the fastest recruiter of subjects across the
world.
Some of the top medical/technical universities in Asia.
continue..
The clinical community is populated with English speaking,
western-trained graduates.
Sophisticated technological infrastructure.
100 million plus English speaking/trained professionals(Largest
outside US).
Over 2million science postgraduates and growing…
Large pool of treatment naïve patients from multi ethnic and
multiracial backgrounds.
Better patient recruitment, retention and compliance.
Participants generally benefit, as the trials conducted in India,
mostly in phase II -IV, provide improved care and cost savings
as procedures and drugs are provided at no charge.
 Captive Research
Most Big Pharma have set up captive centers that are conducting
multicentre trials in India.
They are either operating through a complete in-house model with their own
employees and infrastructure or in-sourcing FTEs from MNC/Indian CROs to
carry out their clinical trial operations in the country.
MNC Ongoing Trials (between Operative model of
2004-09 ) Captive Research

Pfizer 61 Inhouse + Insource

GlaxoSmithKline 59 Inhouse
Eli Lilly 34 Inhouse + Insource
Novartis 32 Inhouse
Sanofi -Aventis 42 Inhouse
Indian CR market will grow to US $1.5 billion in value by
2010.
Other Site Staff

Investigator

Supply
CRO Staff Demand

Sponsor Staff

0 1000 2000 3000 4000 5000 6000 7000

Fastest growing segment in the healthcare / pharmaceutical industry
Excellent Opportunity to Develop Combination of Technical and
Management Skills
Part of the Global Growth Opportunity
Wider Job Horizon
Rapidly Growing Opportunities…and growing (internal and external)
Attractive Compensation and future growth
Higher Job Satisfaction
Continuous Training Opportunities
International Opportunities
The clinical research industry is credited for a new and
increasing awareness and emphasis on the need for education and
training.
However, although the industry may be observing an upward
trend in support of such, it is obvious that resistance remains.
Until the clinical research industry requires and/or standardizes
such training and education, it remains optional to those coming
into our industry and we will continue to see many who are
uneducated and lack the necessary skills to fulfill their defined
roles.
As an industry, education and training standards should be raised.
The industry should require that professionals in this industry be
trained and educated to perform the roles expected of them.
DETAILS

Course: Advanced Post Graduate Diploma in Clinical

Research
Duration : 6 months
Methodology: Regular Classroom studies for 3 months
+
Practical training for next 3 months in chosen field of
CDM/PV/QA-QC will be provided.
IICR’s PGD-CR program is a complete package of theory
and practical training.
Classroom teaching by eminent faculty involving
Lectures and Power Point Presentations is to provide
complete understanding of the clinical research.
Practical training into CRO for 3 months in chosen
specialisation of Clinical Data Management/
Pharmacovigilance / QA-QC will be provided as per the
industry demands.
Through this students enables themselves to fulfil the
demand of trained manpower into the industry.
Pharmaceutical Companies
Clinical CROs (Contract Research Organizations)
BA/BE Centers
SMOs (Site Management Organizations)
Data Management CROs
IT Companies in Healthcare / Clinical Domain
•EDC Service Providers
•Central Laboratories
•Packaging & Labeling & Contract Manufacturers
•Investigator & Site Staff
•Training Centers.
 Clinical Trial Assistant (CTA)
Clinical Research Associate (CRA)
Senior CRA Phase I / II / III / IV Trial
Clinical Team Leader Project Management
Project Manager Drug Development Planning
Senior Project Manager Monitoring
Manager Medical & Regulatory Source Data Verification
Manager –Safety / Patents Safety Reporting
Manager Quality Assurance Regulatory Approval
Medical Director QA Audits
Associate Director Clinical
Business Development
Associate Director –Projects
Director –Business Development
Director / Head (Clinical Operations)
General Manger / CEO / President

The secret of success in life is for a man to be ready for his

opportunity when it comes.
Thank You..