Clinical Research Organizations (CROs) play a crucial role in the drug development process by providing a wide range of services to pharmaceutical and biotechnology companies, academic institutions, and government agencies. Here are the key roles and contributions of CROs in drug development

1. Welcome
THE ROLES OF CLINICAL RESEARCH ORGANIZATION
IN DRUG DEVELOPMENT
VEERESH N
DOCTOR OF PHARMACY
118/062023
10/18/2022
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2. INDEX
1. Introduction
2. An overview of CROs
3. CRO Logo
4. Qualification of CRO
5. Roles and responsibilities of CRO in drug development
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3. CONTRACT RESEARCH
ORGANIZATION
INTRODUCTION:
Clinical research organization also called as contract research organization is
an independent organization that helps pharmaceutical companies in the
development process of a new molecule, drug or a device.
•Pharmaceutical industry
•Biotechnology industry
•Medical device industry
•Government institutions
•universities
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4. Various companies are involved in this type of development,
Examples: Lupin, Quintil, Zydus, etc…
They are also conduct these type of trials with the
collaboration of many multi national companies and these
Indian companies are making space in foreign.
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Support
services
CRO Services
Regulatory
submission
SMO Services
CRO
Audit services

6. An Overview of CROs
Treditionally, a CRO was viewed by pharmaceutical industry something as ;
• An unacceptable risk, because of lack of confidence in terms of their
qualification, experience and capabilities.
• However the modern view is that the in house staff can be kept for core
needs;
Example:
• Designing of study
• Selection of CRO
• A list of qualified CRO is developed based on sponsors needs - the range of
service provided by CRO – the therapeutic area of expertise of CRO, and the
compatability with the sponsor.
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Experienc
e
CRO
CRO Logo:

8. Qualification of CRO
 A bachelors degree in pharmacy or life sciences is a must to do post
graduate courses in clinical research.
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9. Roles and Responsibilities
• If the sponsor has provided detailed study specifications and the CRO
experienced in the target therapeutic area, it will be possible for the
CRO to;
• Compare its past experience with the sponsor projections.
CRO roles and responsibilities are…
• Evaluate feasibility
• Provide adequate, well managed staff
• Conduct study activities
• Manage processes
• Bring problems and proposed solutions to the sponsors attention
• Ensure that the solutions are cost effective
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10. • CROs are design to reduce costs for companies developing new medicines
and drugs.
• The aim to simplify entry into drug markets, and simplify development, as
the need for large pharmaceutical companies to do everything in house is
now redundant.
• The act of outsourcing clinical research tasks help a biotech or pharma
company save the time and money while guaranteeing the completion of
its project within the given constraints.
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Post marketing
surveillence
Clinical trial:
Protocol development
initiation and monitoring
and investigation, analysis
and reporting etc..
Regulatory
submission
Product development
and pre-clinical
testing
Project initiation and
feasibility
CRO

12. Thank You!
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