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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)
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AGENDA
TERMINOLOGIES
OUTSOURCING MEANS. CRITERIA OF OUTSOURCING OF CLINICAL
TRIALS
DIFFERENT SCENARIOS OF OUTSOURCIING
SPONSORS DECISION IN OUTSOURCING OF
CLINICAL TRIAL OUTSOURCING IN CLINICAL RESEARCH
THE INDIAN PERSPECTIVE
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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 scientificinformation on prevention, early detection and early diagnosiscan be efficiently applied; and
Operations and implementation reserach that uses analyticaltechniques such as epidemiological modeling and cost-effectiveness analysis to determine how to achieve betterhealth outcomes and optimal service delivery
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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 andfastest 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
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Outsourcing means
Outsourcing involves transferring or sharingmanagement control and/or decision-makingof a business function to an outside supplier,which involves a degree of two-wayinformation exchange, coordination and trust
between the outsourcer and its client. Businesssegments typically outsourced includeinformation technology, human resources,
facilities and real estate management, andaccounting. Many companies also outsourcecustomer support and call center functions,
manufacturing and engineering.
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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?
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Criteria for outsourcing
(1) Technical criteriaProcess
(2) Legal criteriaSecrecy regulations
Safety regulations
(3) Strategic criteria
Core competencies
Processes in growing markets
(4) Suitable enterprises
Suitable companies existing on the market
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DIFFERENT SCENARIOS OF OUTSOURCING
OVERVIEW:
Cost of drug development
Mounting market pressures
Reshaping the drug development services
industry
Evolution of CRO
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DIFFERENT SCENARIOS OF OUTSOURCING
Current scenario:
Drivers of outsourcing
Downward cost pressures
Upward cost pressures
Resistant to CRO
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DIFFERENT SCENARIOS OF OUTSOURCING
Future outlookReasons 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 thepersonnel, 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 ofinterest
Increased complexity of clinical trials
Increased amount of data required from clinical trials
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Sponsors decision in Outsourcing
Sponsor is the main person or the individual who decides thatwhether to outsource the Clinical Trial to the CRO (ContractResearch Organization) or not & if yes then he is the onlyperson who undergoes the process of Outsourcing of ClinicalTrial by taking into consideration the following point1. 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 not6. Whether the CRO has proper lab. Facilities or not
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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
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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 cheapersalaries.
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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 GCPclinical 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.
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THANK YOU