Accelerate Clinical Trial Start-Up From Feasibility to First Patient In
Table of Contents
Chapter 1. Clinical Trial Start-Up: Scope, Objectives, and Operating Model
1.1 What Clinical Trial Start-Up Must Deliver
1.2 The Start-Up Value Chain: From Feasibility to First Patient In
1.3 Key Stakeholders, Decision Rights, and Governance Forums
1.4 Common Failure Modes in Trial Start-Up
1.5 Start-Up Readiness Checklist
Chapter 2. Feasibility Strategy and Country Selection
2.1 Defining the Feasibility Question
2.2 Country Selection Criteria and Trade-Offs
2.3 Epidemiology, Standard of Care, and Patient Access
2.4 Investigator Input, Site Intelligence, and Enrollment Risk
2.5 Country Feasibility Template
Chapter 3. Site Identification, Qualification, and Selection
3.1 Building the Target Site Profile
3.2 Site Identification Sources and Screening Methods
3.3 Site Qualification Visits and Remote Assessments
3.4 Final Site Selection and Portfolio Balance
3.5 Site Selection Scorecard
Chapter 4. Start-Up Planning, Timeline Management, and Critical Path Control
4.1 Building the Integrated Start-Up Plan
4.2 Critical Path Activities and Key Dependencies
4.3 Country and Site Activation Milestones
4.4 Risk Tracking, Escalation, and Recovery Planning
4.5 Start-Up Timeline Control Template
Chapter 5. Contracts, Budgets, and Site Negotiation
5.1 Contracting Strategy and Required Agreements
5.2 Site Budget Structure and Fair Market Value
5.3 Negotiation Workflow, Roles, and Escalations
5.4 Common Bottlenecks in Contracts and Budgets
5.5 Contract and Budget Tracker
Chapter 6. Regulatory, IRB/EC, and Ethics Submission Management
6.1 Regulatory Start-Up Requirements by Country
6.2 IRB/EC Submission Strategy and Documentation
6.3 Essential Documents and Submission Package Quality
6.4 Managing Queries, Approvals, and Amendments
6.5 Regulatory and Ethics Submission Checklist
Chapter 7. Site Activation, Greenlight, and First Patient In
7.1 Activation Requirements and Site Greenlight Criteria
7.2 Site Training, Systems Access, and Supply Readiness
7.3 Investigator Meeting and SIV Planning
7.4 First Patient In Readiness and Enrollment Launch
7.5 Site Activation Readiness Checklist
Chapter 8. External Support Options for Clinical Trial Start-Up
8.1 When to Engage External Advisors
8.2 Support from Large Consulting Firms and CROs
8.3 Specialist Vendors and Functional Experts
8.4 Independent Management Consultants Through Umbrex
8.5 Advisor Selection and Engagement Checklist
