CONCEPT OF CRO BY PRANAV LENDHEY.pptx

contract research organization

1. CONCEPT OF CONTRACT RESEARCH ORGANIZATION (CRO) BHARATI VIDYAPEETH COLLEGE OF PHARMACY, KOLHAPUR Presented by Mr. Pranav S Lendhey M. Pharm I Year Department of Pharmaceutics Guided by Mr. U.S.Patil Sir Assistant Professor Department of Pharmaceutics 1

2. Introduction Need of an CRO CRO roles and responsibilities Services Provided by CRO How To Choose a CRO Requirement for C linical Trial CRO’s have conducted three different types of trials Requirements of CRO CRO’s Growth and investment Top Indian CRO’s Challenges For CRO’s in India Drawbacks in Indian CRO’s Conclusion CONTENT 2

3. INTRODUCTION A Contract Research Organization (CRO) is a service organization which provides support to the pharmaceutical industry It offers various pharmaceutical research that is essential for conducting clinical trials Various companies are involved in this type of development many examples are the like Lupin , Quintil , Cipla , Zydus , Cadeila . they are also conduct these type of trails with the collaboration of many multinational companies and these Indian companies are making space in foreign. 3

4. NEED OF AN CRO : In early 1980s, a pharmaceutical company was expected to do all of its own work. Sometime they faced capacity problems . So the need for excess capacity has increased, that led to the formation of the first Contract Research Organizations (CRO ). The boom in the Biotech industry was led to a sharp increase in demand for CRO services, as many smaller firms are had plenty of money but deficient of internal capacity, they sought to improve their developmental projects. They need a help from CRO’S for their work The scattered structure of the CRO industries has led to an improve in their joint ventures, acquisitions, strategic alliances and other partnership agreements as companies seek to expand their service offerings and geographic presence 4

5. CRO ROLES AND RESPONSIBILITIES Evaluate feasibility(Practicability) Provide adequate well managed staff Conduct study activities Manage processes Bring problems and proposed the solutions to the sponsor Ensure that the solutions are cost-effective 5

6. SERVICES PROVIDED BY CRO’S Formulation and manufacturing Medical and safety monitoring Clinical trial management Toxicology Preclinical Product development and clinical laboratory services Medical writing services for the development of USFDA'S - NDA, ANDA. Regulatory Submission Post Marketing surveillance 6

7. HOW TO CHOOSE A CRO 7

8. REQUIREMENTS FOR CLINICAL TRIALS GCT Approval Safety report Test license Clinical trials registry India(CTRI) Ethical committee Registration 8

9. CRO’S HAVE CONDUCTED THREE DIFFERENT TYPES OF TRIALS 1) Phase 1 , It gives the research study on bioequivalence and biosimilars , which is implemented by Indian companies and also by international sponsors interested in the production of generic drugs. 2 ) Phase 3b trials , It is the small mandated trials by Indian regulators before a drug has access to Indian markets; this is a special requirement for international pharmaceuticals for market their products 3) Multi-site randomized controlled trials located in India, sponsored by international pharmaceutical companies 9

10. REQUIREMENTS OF CRO It must have technical skills, quality, lead times and costs It must have strict quality assurance operations to ensure deliverables should meet the global regulatory compliance In general, an Indian CRO is judged on parameters such as innovations, Compliance with GCP-ICH guidelines, financial stability; profitability and value for money, overall experience, skillsets, global reach, reputation and public image, validation, work culture, turnover. 10

11. CRO GROWTH AND INVESTMENT The global CRO market is valued at $ 36 billion in 2018 It anticipated to reach $ 45 billion by 2023 The government organizations had given their clinical trial activities to CRO’S so that they can perform clinical trials with essential infrastructure and to minimize costs and time Many pharma firms had plan to spend more than $ 50 million / year on contract research services 11

12. TOP INDIAN CRO’S PPD. Pharmaceutical Product Development (PPD) is a leading global CRO that employs over 30,000 people worldwide. KCR ICON Parexel Medpace Syneos Health Labcorp . 12

13. CHALLENGES FOR CRO’S IN INDIA Financial challenges Regulatory challenges Lack of ICH-GCP Compliant Search Sites Emergence of non-accredited CRO’S Lack of patient awareness Merchandising at contract prices 13

14. DRAWBACKS IN INDIAN CRO's Some of the Indian CRO’S lack trained and lack of experience in CRO Services. Some other areas where problems could arise are (1)Changes in key personnel in the study or organization (2)Lack of clarity in the lines of authority and responsibilities of signatories: (3) lack of regulatory compliance ; (4) D eficiencies in quality control procedures or quality assurance procedures ; (5) poor or inappropriate selection of the appropriate technology to generate data (6) poor communication or ineffective communication (7) the use of silent or stealthy subcontractors (8) over-commit to too much work for the available resources at hand (9) simple superfluous events associated with the commission of error (10) Acts of nature 14

15. CONCLUSION The Huge expansion of testing activity in India required the active support of local firms and researchers. Inside the research-based pharmaceutical organizations, Indian CROS have served both globally and locally The main concern of industrial researchers was the safety and security of research participants those who involved in the study The global pharmaceutical companies that contract with the local CRO’S to conduct research in India. So, that the need of an CRO is an indispensable part of Pharma society. 15

16. REFERENCES Roles of contract research organizations in translational medicine by Mei- Shu Shih in Journal of Orthopaedic Translation (2015) 3, 85e88 . Zhou JB, Wu DJ, Liu XQ, Yuan SQ, Yang XQ, Wang XD. Translational medicine as a permanent glue and force of clinical medicine and public health: perspectives (1) from 2012 Sinoc American symposium on clinical and translational medicine. Clin Transl Med 2012;1:21e4 .. Review of Emerging trends in contract research industry in India by Sushma Drabu , Alka Gupta, Anupama Bhadauria in Contemporary Clinical Trials 31 (2010) 419-422 . Indian Pharma Enters the Global Arena Report from Meticulous Market Research Pvt. Ltd . Clinical Research Outsourcing Overview: Current Scenario & Future Outlook by Dr. Jayashree . IBPA publications 2005 Contract Research Organization exclusion criteria 16

17. THANK YOU 17