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CLINICAL RESEARCH

EDUCATION PROGRAM
(2007-2008)
A PRESENTATION ON

“CLINICAL RESEARCH OUTSOURCING”

PRESENTED BY: ANKUR.R.PATEL


(THIRD YEAR B.PHARM)
AGENDA

• TERMINOLOGIES
• OUTSOURCING MEANS….
• CRITERIA OF OUTSOURCING OF CLINICAL
TRIALS
• DIFFERENT SCENARIO’S OF OUTSOURCIING
• SPONSOR’S DECISION IN OUTSOURCING OF
CLINICAL TRIAL
• OUTSOURCING IN CLINICAL RESEARCH –
THE INDIAN PERSPECTIVE
CLINICAL RESEARCH …
• Definition of Clinical Research:
• Clinical research is defined by the foundation as research
conducted with human subjects including:
• Studies on the etiology and pathogenesis of human disease;
• Therapeutic interventions;
• Clinical trials;
• Epidemiological studies;
• Disease control research that investigates how scientific
information on prevention, early detection and early diagnosis
can be efficiently applied; and
• Operations and implementation reserach that uses analytical
techniques such as epidemiological modeling and cost-
effectiveness analysis to determine how to achieve better
health outcomes and optimal service delivery
CLINICAL RESEARCH…
• Clinical Trial:
• Definition:
• A clinical trial is a research study in human
volunteers to answer specific health questions.
Carefully conducted clinial trials are the safest and
fastest way to find treatments that work in people,
and new ways to improve health.
• Phases of clinical trials:
• Phase I
• Phase II
• Phase III
• Phase IV
Outsourcing means…
• Outsourcing involves transferring or sharing
management control and/or decision-making
of a business function to an outside supplier,
which involves a degree of two-way
information exchange, coordination and trust
between the outsourcer and its client. Business
segments typically outsourced include
information technology, human resources,
facilities and real estate management, and
accounting. Many companies also outsource
customer support and call center functions,
manufacturing and engineering.
WHY OUTSOURCING ?

• Do we have in-house resources?


• Are the resources available?
• Would these resources be optimally
employed on this project?
• Is it cost-effective to do the project in-house?
• Can we do it fast enough?
Criteria for outsourcing
(1) Technical criteria
Process
(2) Legal criteria
Secrecy regulations
Safety regulations
(3) Strategic criteria
Core competencies
Processes in growing markets
(4) Suitable enterprises
Suitable companies existing on the market
DIFFERENT SCENARIO’S OF OUTSOURCING

OVERVIEW:
• Cost of drug development
• Mounting market pressures
• Reshaping the drug development services
industry
• Evolution of CRO
DIFFERENT SCENARIO’S OF OUTSOURCING

Current scenario:
• Drivers of outsourcing
• Downward cost pressures
• Upward cost pressures
• Resistant to CRO
DIFFERENT SCENARIO’S OF OUTSOURCING
Future outlook
Reasons for outsourcing
Outsourcing offers a number of advantages to the companies.
These include:
• Reduces the time (8 to 15 years) required to develop and bring
a new drug to market
• Sponsor can convert the fixed costs of maintaining the
personnel, expertise and facilities like data management)
necessary for clinical trial management into variable costs
• Non-availability of services in-house
• Less knowledge of regulatory affairs in a particular country of
interest
• Increased complexity of clinical trials
• Increased amount of data required from clinical trials
Sponsors decision in Outsourcing

Sponsor is the main person or the individual who decides that


whether to outsource the Clinical Trial to the CRO (Contract
Research Organization) or not & if yes then he is the only
person who undergoes the process of Outsourcing of Clinical
Trial by taking into consideration the following point
1. Where to Outsource (Country)
2. Whom to Outsource (CRO)
3. What part to Outsource
4. When to Outsource
5. Whether the CRO capable of undergoing the Trials or not
6. Whether the CRO has proper lab. Facilities or not
Outsourcing in Clinical Research - The Indian Perspective

Introduction :
• New pharmaceutical strategies
• World market for contract clinical research services
growing at 13.4%
• India and China share the major chunk of benefits
• Low Revenues
Reasons for outsourcing in Clinical Research in India

In India ,
• Costs become very easy and cheap .
• Intensive and Strict Animal guidelines.
• Rich man power.
• 30 million people have heart disease.
• 25 million have type-II diabetes.
• 10 million suffer psychiatric disorders.
• Availability of man power at comparatively cheaper
salaries.
Reasons for outsourcing in Clinical Research in India

• Quality and rapid response


• Increased awareness of Good Clinical
Practices (GCP) requirements
• Stronger desire of international acceptability of
research done in India
• Investigators are eager to take part in GCP
clinical trials and are also willing to adhere to
constraints of the protocol.
• Recently the Ministry of Health, along with
DCGI and ICMR has come out with draft
guidelines for research in human subjects.
THANK YOU

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