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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