| Monday, October 19, 2026 |
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| 10:00 AM - 11:00 AM | Subject Injury Trapdoors | Contracts |
| 10:00 AM - 11:00 AM | Introduction to Clinical Trial Billing: How It All Fits Together | Billing Compliance |
| 10:00 AM - 11:00 AM | AI Prompting 101: Communicating With Your New Teammate | Artificial Intelligence |
| 11:00 AM - 11:30 AM | Break | |
| 11:30 AM - 12:30 PM | Blindsided: Legal, Operational and Insurance Mistakes That’ll Leave a Mark | Contracts |
| 11:30 AM - 12:30 PM | Reading a Protocol for Billing: What to Look For and Why It Matters | Billing Compliance |
| 11:30 AM - 12:30 PM | Introducing AI to the Legal Department | Artificial Intelligence |
| 12:30 PM - 1:00 PM | Break | |
| 1:00 PM - 2:00 PM | AI & Change Management: Bringing Your Team Along | Artificial Intelligence |
| 1:00 PM - 2:00 PM | What FDA Warning Letters on Informed Consent Are Telling Us | Quality/Regulatory |
| 1:00 PM - 2:00 PM | Leadership Under Pressure: Sustaining Clinical Operations Teams Through Change, Burnout, and Complexity | Clinical Operations |
| 1:00 PM - 2:00 PM | Introduction to Clinical Trial Budgets: Key Components and Terminology | Budgets |
| 2:00 PM - 2:30 PM | Break | |
| 2:30 PM - 3:30 PM | The Future of Community-Based Clinical Trials: Building Sustainable, Scalable, and Equitable Research Models | Clinical Operations |
| 2:30 PM - 3:30 PM | Transforming Compliance Culture: A “Wellness Visit” Approach to Advancing Research Quality | Quality/Regulatory |
| 2:30 PM - 3:30 PM | Understanding Study Costs: What Drives Site Expenses | Budgets |
| 2:30 PM - 3:30 PM | AI for End-to-End Study Startup | Artificial Intelligence |
| Tuesday, October 20, 2026 |
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| 10:00 AM - 11:00 AM | From “No AI” to “Know AI” in Clinical Trial Agreements | Contracts |
| 10:00 AM - 11:00 AM | Words Matter: When Financial Promises Become Compliance Obligations | Billing Compliance |
| 11:00 AM - 11:30 AM | Break | |
| 11:30 AM - 12:30 PM | Reimbursement and Coverage Analysis | Billing Compliance |
| 11:30 AM - 12:30 PM | Challenging Our Assumptions on Risk Management. | Contracts |
| 12:30 PM - 1:00 PM | Break | |
| 1:00 PM - 2:00 PM | What the One Big Beautiful Bill Act (OBBBA) Means for Clinical Trial Operations | Clinical Operations |
| 1:00 PM - 2:00 PM | Responsible AI: Governance, Oversight & “Who Reviewed the Robot?” | Quality/Regulatory |
| 1:00 PM - 2:00 PM | Budgeting for Start-Up, Closeout, and Administrative Work | Budgets |
| 2:00 PM - 2:30 PM | Break | |
| 2:30 PM - 3:30 PM | When the Site Says No: How Participant Payment Advocacy Changed a Sponsor’s Mind | Budgets |
| 2:30 PM - 3:30 PM | Winning Playbook: Launching a World Class Research Site | Clinical Operations |
| 2:30 PM - 3:30 PM | Applying ISO 9001 Principles to Clinical Research | Quality/Regulatory |
| 3:30 PM - 4:00 PM | From Protocol to Defensible Budget: AI-Assisted Coverage Analysis and Budget Development | Sponsored Session |
| 3:30 PM - 4:00 PM | Sponsored Session | Sponsored Session |
| 4:00 PM - 4:30 PM | Navigating Coverage Analysis in Cell Therapy Trials | Sponsored Session |
| 4:30 PM - 5:00 PM | Sponsored Session | Sponsored Session |
| Wednesday, October 21, 2026 |
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| 10:00 AM - 11:00 AM | Expanded Access & Compassionate Use Agreements | Contracts |
| 10:00 AM - 11:00 AM | From Complexity To Clarity: The Clinical Research Billing Compliance Audit Process | Billing Compliance |
| 11:00 AM - 11:30 AM | Break | |
| 11:30 AM - 12:30 PM | Negotiating AI-Related Clauses in Contracts | Contracts |
| 11:30 AM - 12:30 PM | CTMS, EMR, and Humans: Building Research Billing Compliance Without Losing the Plot | Billing Compliance |
| 12:30 PM - 1:00 PM | Break | |
| 1:00 PM - 2:00 PM | From Amendment Whiplash to Activation Velocity | Budgets |
| 1:00 PM - 2:00 PM | Panel Discussion: R3 Transition Office Hours: Small-Group SOP Troubleshooting | Quality/Regulatory |
| 1:00 PM - 2:00 PM | Panel Discussion: AI at the Front Door - Faster Screening, Better Enrollment | Clinical Operations |
| 2:00 PM - 2:30 PM | Break | |
| 2:30 PM - 3:30 PM | Managing FDA Inspections | Quality/Regulatory |
| 2:30 PM - 3:30 PM | Building a Lifecycle Approach to Clinical Operations | Clinical Operations |
| 2:30 PM - 3:30 PM | The CRO Role in Budget Negotiations: Balancing Sponsor and Site Needs | Budgets |
| 3:30 PM - 4:00 PM | The New Carbon Copy: AI-Native EDC for Real-Time Clinical Research | Sponsored Session |
| 4:00 PM - 4:30 PM | Who Decides? Navigating AI Governance in Clinical Research | |
| Thursday, October 22, 2026 |
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| 10:00 AM - 11:00 AM | Indemnification: What's Fair for Each Party? | Contracts |
| 10:00 AM - 11:00 AM | Egad! A Device Trial?! What Makes Device Research Billing Different" | Billing Compliance |
| 11:00 AM - 11:30 AM | Break | |
| 11:30 AM - 12:30 PM | Panel Discussion: AI That Talks to Everything: MCP, Governance, and the Future of Trial Tech | Billing Compliance |
| 11:30 AM - 12:30 PM | Fast-Tracking Negotiations to "Yes": The Soft Skills for Faster Contracting | Contracts |
| 12:30 PM - 1:00 PM | Break | |
| 1:00 PM - 2:00 PM | Holdback is Not a Quality System and Other Hidden Costs | Budgets |
| 1:00 PM - 2:00 PM | From Vision to Execution: Turning Big Ideas into Reality | Clinical Operations |
| 1:00 PM - 2:00 PM | Beyond Compliance: Preparing Investigator Sites for ICH E6(R3) | Quality/Regulatory |
| 2:00 PM - 2:30 PM | Break | |
| 2:30 PM - 3:30 PM | Portfolio-Level Budget Planning for Research Leadership | Budgets |
| 2:30 PM - 3:30 PM | What the IRB Sees: Noncompliance Patterns from the Other Side of the Submission | Quality/Regulatory |
| 2:30 PM - 3:30 PM | Investigator Engagement & Clinical Affairs: Driving Stronger Trial Execution | Clinical Operations |
| 3:30 PM - 4:00 PM | Sponsored Session | Sponsored Session |
| 3:30 PM - 4:00 PM | Modernizing Patient Recruitment: AI Tools, Workflows, and Outcomes | |
| 4:30 PM - 5:00 PM | Sponsored Session | Sponsored Session |
| Friday, October 23, 2026 |
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| 10:00 AM - 11:00 AM | Clinical Trial Budgeting, CAR-T coverage Analysis, General Coverage Analysis | Billing Compliance |
| 10:00 AM - 11:00 AM | Key Contract Considerations for Industry-Supported Investigator-Initiated Clinical Trial (IIT) Agreements | Contracts |
| 11:00 AM - 11:30 AM | Break | |
| 11:30 AM - 12:30 PM | Panel Discussion: How to Explain Study Costs & Billing to Patients | Billing Compliance |
| 11:30 AM - 12:30 PM | Panel Discussion: Contracts - Stump the Experts | Contracts |
| 12:30 PM - 1:00 PM | Break | |
| 1:00 PM - 2:00 PM | Panel Discussion: Bringing Clinical Research to Rural Patients: Overcoming Barriers, Shifting Perceptions, and Lessons from a Research Navigation Program | Clinical Operations |
| 1:00 PM - 2:00 PM | Using Historical Data to Improve Budget Accuracy | Budgets |
| 1:00 PM - 2:00 PM | CAPA-Beyond the Fix: Understanding Root Cause, Corrective Action & Prevention | Quality/Regulatory |
| 2:00 PM - 2:30 PM | Break | |
| 2:30 PM - 3:30 PM | Panel Discussion: The TMF Is the Trial - What eTMF Audits Actually Find | Quality/Regulatory |
| 2:30 PM - 3:30 PM | Using AI and Automation to Accelerate Study Budget Development | Budgets |
| 2:30 PM - 3:30 PM | Embedding Compliance into Clinical Research Operations | Clinical Operations |