CONTRACT RESEARCH ORGANIZATION
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The document discusses the role and significance of Contract Research Organizations (CROs) in the pharmaceutical industry, highlighting their support in clinical trials and drug development. It outlines strategies for collaborating with CROs, common issues faced, and essential steps for successful outsourcing, including selecting the right CRO and defining roles and responsibilities. Additionally, the document emphasizes the importance of compliance, legal contracts, data confidentiality, and effective communication between sponsors and CROs.
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CONTRACT RESEARCH ORGANIZATION
- 1. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 CONTRACT RESEARCH ORGANIZATION Raghavendra Institute of Pharmaceutical Education and Research(RIPER)- Autonomous JNT University Anantapur A Seminar as a part of curricular requirement for I year M.Pharmacy I Semester 1 Presented by G.ARAVIND KUMAR (20L81S0101) Industrial pharmacy Under the guidance of Dr. E. Bhargav M.Pharm, (Ph.D.) Assistant Professor Department of Industrial Pharmacy
- 2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 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 in the present boom, when various complications are involved in the drug discovery process. Various companies are involved in his 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. 2
- 3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 BACKGROUND There is a growing reliance by sponsors on contracting out part or all of the work of the clinical trial to a sub-contractor. Manufacturers often find that they cannot organize every clinical trial that they require. The reasons are many, but commonly reflect; limited staff resources pressures of time. Subsequently, the field has expanded to include firms in the areas of; – formulation development – stability programs – pharmacokinetic studies – biostatistics –data management 3
- 4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 An Overview of CROs Traditionally, a CRO was viewed by pharmaceutical industry something as; an un-acceptable risk, because of lack of confidence in it terms of their qualification, experience and capabilities. However, the modern view is that the in- house staff can be kept for “core needs” e.g., designing of study selection of CRO. A list of qualified CROs is developed based on; – The sponsors needs – The range of services provided by CRO – The therapeutic area of expertise of CRO, and – The compatibility with the sponsor 4
- 5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 MARKET STRUCTURE OF CRO Top 10 CROs-75%Revenue Avg revenue /company $1.3 ue 5 Top 10 CROs-75%Revenue Avg revenue /company $1.3 billion Next 10 CROs -11% revenue Avg revenue/company-$220 Million Niche segment 14% revenue Avg Revenue /company-$3.1 Million 5
- 6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 WHEN TO USE A CRO? Strategies for using CROs typically fall into three categories: – Tactical outsourcing – Maximal outsourcing – Strategic outsourcing Tactical Outsourcing Individual studies or selected activities within a study are contracted to a CRO only when in-house resources become inadequate because of an unfore-seen study or a reduction in staff. Maximum Outsourcing With this strategy the sponsor outsources nearly all of its clinical development activities to CROs. Strategic Outsourcing The sponsor conducts Phase I and early Phase II studies, and hires CROs to conduct larger and routine studies 6
- 7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 FREQUENT CAUSES OF SPONSOR/CRO PROBLEM Problems with contract studies can often be traced by; – The wrong CRO is selected. – Sponsors often make the mistake of assuming that a CRO that has performed well on one study will be equally capable of conducting a study in a different therapeutic area. Some sponsors mistakenly assume that all CROs are the same. – The sponsor fails to articulate its needs clearly. – Sponsors sometimes issue a request for proposal (RFP) with little more than a protocol outline, and expect CROs to guess what services and resources are required. 7
- 8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 THREE CRITICAL STEPS TO ENSURE SUCCESS WITH A CRO • In order to ensure successful outsourcing, the sponsor should focus on three critical steps: – Determine accurate study specifications – Select the right CRO – Manage the study 8
- 9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 DETERMINE STUDY SPECIFICATIONS Study specifications are a list of activities required to initiate, conduct, analyze, and report the results of a clinical study. They include tasks that will be performed in-house and those to be contracted out to one or more CROs. Importance of Accurate Study Specifications Study specifications are an essential element of the sponsor’s request for proposal (RFP) and the CRO’s proposal. Accurate study specifications also enable the CRO to perform a ‘reality check’ on the sponsor’s expectations. This analysis also provides useful criteria for selecting the right CRO 9
- 10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 SELECTING THE RIGHT CRO The three most important criteria for selecting a CRO are: – Capability – Compatibility – Cost MANAGING THE SPONSOR-CRO RELATIONSHIP The sponsor should follow three principles for managing an outsources project: – Clarify the role and responsibilities of the sponsor and CRO. – Define and use ‘performance metrics’ to measure study progress. – Ensure efficient communication between the sponsor and CRO. 10
- 11. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Sponsor Roles and Responsibilities – Define the study specifications – Provide information to the CRO – Monitor results – Recognize ‘red flags – Resolve problems – Approve changes in ‘scope 11
- 12. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 CRO Roles and Responsibility If the sponsor has provided detailed study specifications and the CRO is experienced in the target therapeutic area, it will be possible for the CRO to; compare its past experiences with the sponsor’s 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 sponsor’s attention – Ensure that the solutions are cost-effective 12
- 13. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Sponsor-CRO Study Initiation Meeting The sponsor and CRO teams should hold a ‘kick-off’ meeting prior to initiation of the study. The goals of the meeting are: – To promote ownership of the study among team members – To clarify the roles and responsibilities of the sponsor and CRO – To identify the primary sponsor and CRO contacts – To present the agreed to performance metrics and audit procedures – To define the approach to problem resolution – To define those changes that can be agreed upon informally and those that require a formal change order 13
- 14. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 IDENTIFYING AND RESOLVING PROBLEMS They should be identified at an early stage, so that they have minimal impact on study cost, timing, and quality. It is important for a team member to inform the project manager of any issue before attempting to resolve it. This information will enable the project manager to determine; – whether the problem is an isolated case. – is part of a larger problem that needs to be addressed with the corresponding project manager. 14
- 15. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Ten ‘Red Flags Red flags are early warning that may not require immediate action, but should be evaluated to determine whether a significant underlying problem exists. Each team member may wish to prepare a list of red flags for his/her individual technical area. Typical red flags and the possible significant underlying problems are: – Selection of in-experienced investigators by the CRO: the CRO monitoring staff may be inexperienced . – Questions from the study site directed to the sponsor: the CRO may not have provided adequate training to site personnel. – In-adequate monitoring reports from the CRO: the CRO monitoring staff may not be receiving adequate training and supervision. 15
- 16. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 CONTRACT RESEARCH Legal Background The arrangements made for the conduct of clinical research will usually give rise to a number of legal contracts. For example, there will be a contract between a sponsor and any appointed clinical research organization (CRO); between the sponsor or CRO and the investigator or the institution in which the investigator works. It would be unusual to have a contract between a patient participant and the sponsor or investigator, although this may arise where the participant is a private patient of the investigator 16
- 17. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Compliance A specified party must hold or obtain (and maintain) all necessary authorizations. All legal and regulatory requirements (including labeling) must be complied with. Compliance with the ICH,Good Clinical Practice Guidelines or equivalent should be required. The investigator must obtain ethical approval from relevant ethics committees before beginning the study and refer all amendments. The study must be carried out to the highest professional standards 17
- 18. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Timing Start date, duration/end date should be identified. The number of subjects to be recruited by specified dates should be addressed. The options if the recruitment rate is not on target. Provision for making status reports, providing interim analysis reports and submitting the final report by specified date should be made. 18
- 19. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Data Except for the purposes of the study and as required by law, the data must be kept confidential. Retention of title by specified parties (in particular the sponsor) in identified documents and materials should spelled out. Protection of intellectual property rights of the sponsor must be covered. Arrangements for maintaining safety and security of data, documents and trial supplies should be identified. The investigator will maintain all records relating to the study, including case report forms, for as long as is practicable. Responsibility and procedure for notification of Adverse Drug Reactions (ADRs) or other unexpected or unusual occurrences in compliance with the legislation needs to be described. 19
- 20. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Payment The contract should specify: The amounts and timing (advance, stage or interim and final) of payments and the payment of reasonable expenses. Whether separate accounts are to be established. • Provision for alteration of budget in the event of amendment of the protocol, or extent of services to be provided, and early termination. Materials Supply of the investigator brochure, updates, product and documentation by sponsor. 20
- 21. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21