The Role of Clinical Research Organizations (CROs) in Drug Development

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 www.clinosol.com | follow us on social media @clinosolresearch 1

2. INDEX Introduction An overview of CROs CRO Logo Qualification of CRO Roles and responsibilities of CRO in drug development 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3

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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4

5. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5 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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6

7. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7 Experience Cost Capabilities Quality Customer Service & customer relationship 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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9

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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10

11. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11 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

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