Timing (9:30 AM-5:00 PM) Eastern Time USA

Course Agenda
Day One: Understanding Clinical Research Organization (CRO) Oversight

9:00 AM – 10:00 AM: Lecture 1: Clinical Research Organizations (CROs) Importance
  • Role of CROs in clinical research​ 
  • Key functions and services
  • Importance of CRO oversight in clinical trials

10:00 – 11:00 AM: Lecture 2: Overview of Working with a CRO
  • Responsibilities of sponsors, CROs, and investigators in ensuring regulatory compliance
  • Common regulatory compliance issues and their impact on clinical trials
  • Types of Contracting Models
  • Current CRO business model
  • Contract versus project management
  • Overview of CRO Management Steps - RFP, Contract, Oversight, Change in Budget and/or Scopes                                                                                  
11:10AM – 11:15 AM: Break 

11:15 AM – 12:30 PM: Lecture 2: CR) Oversight: 
  • Schematic workflow of a Sponsor/CRO project
  • GCP requirements
  • Budget requirements
  • Company requirements (the extent to which it must be done your way)
  • Measurements/KPI’s
  • Standardized Metrics, Reports, Meeting, Visits in trial sites

CRO Oversight Continued: 
  • Matrix of responsibilities
  • Matrix of valid SOPs
  • Vendor oversight plan
  • Vendor oversight visit template​

1.30 – 2:00 PM: Break

2:00 – 3:00 PM: Regulatory Framework for CRO Oversight
  • Overview of regulatory bodies governing clinical research (FDA, EMA, etc.)
  • Guidelines and regulations pertaining to CRO oversight (ICH GCP, FDA regulations, etc.)
  • Responsibilities of sponsors, CROs, and investigators in ensuring regulatory compliance
  • Common regulatory compliance issues and their impact on clinical trials

3:00 – 3:15 PM: Break

3:15– 4:15 PM: Lecture 3: Risk-Based Approach to CRO Oversight
  • Introduction to risk-based monitoring (RBM) and its application in CRO oversight
  • Identifying and assessing risks associated with CRO activities
  • Developing risk mitigation strategies for CRO oversight
  • Case studies and practical examples illustrating the implementation of RBM in CRO oversight
Day Two: Implementing Effective CRO Oversight Practices

​9:00 AM – 10:00 AM: Lecture 4: Establishing CRO Oversight Plans
  • Components of a comprehensive CRO oversight plan
  • Defining key performance indicators (KPIs) for CRO oversight
  • Developing a risk assessment matrix for CRO activities
  • Creating communication and escalation protocols for effective oversight

​10:00 AM – 11:00 AM: Lecture 5: Sponsor/Vendor Communication 
  • CRO Meetings
  • Effective communication plan
  • Mode of communication
  • Feedback and resolution 
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Break: 11:00 AM – 11:15 AM:
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11:15 AM – 12:00 PM: Lecture 6: CRO Qualification Analysis
  • Criteria during selection phase
  • Evaluation of different selection tools
  • Bid defence meeting
  • Qualification Visit or Audit
  • Standardised Bid-grid/Template
  • Standardised Questionnaire

12:00 PM – 1:30 PM: 

​Request for Proposal (RFP)
  • How your anticipated relationship and oversight should affect your RFP
  • How your selection criteria should affect your RFP (e.g. use of a bid grid)

On-going Changes in the Project
  • Recognizing changes in scope and budget renegotiation 
  • Budget tracking and income 
  • Dealing with requests for budget increase

Types of Sponsor CRO Relationship
  • Preferred provider model
  • Single provider model
  • Size of CRO (Local/MNC’s

Break: 1:30 PM – 2:00 PM

2.00 PM – 3:00 PM: Lecture 7: Monitoring CRO Performance
  • Tools and methodologies for monitoring CRO performance (metrics, site visits, audits, etc.)
  • Establishing performance metrics and benchmarks for CRO activities
  • Conducting regular performance evaluations and assessments
  • Addressing performance issues and implementing corrective actions

3:00 – 4.00 PM: Lecture 7: Building Collaborative Relationships with CROs
  • Importance of fostering collaboration and communication with CROs
  • Strategies for establishing and maintaining effective partnerships with CROs
  • Best practices for managing relationships between sponsors and CROs
  • Case studies highlighting successful collaborations between sponsors and CROs
  • ​Analyzing and discussing real-life case studies related to CRO oversight