| Monday, October 20, 2025 |
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| 10:00 AM - 11:00 AM | Building Blocks of Revenue Cycle & Research | Billing Compliance |
| 10:00 AM - 11:00 AM | CTA Compromise Terms | Contracts |
| 11:30 AM - 12:30 PM | Billing Compliance & Medicare Coverage Analysis | Billing Compliance |
| 11:30 AM - 12:30 PM | Negotiating CTAs with CROs: Bootcamp on LOIs, POAs and Party Structure | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Devices Are Different: What Every Clinical Research Professional Needs to Know About Device Trials | Clinical Operations |
| 1:00 PM - 2:00 PM | Developing a Site Budget from Protocol | Budgets |
| 1:00 PM - 2:00 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | AI in Clinical Trials: Lessons Learned, Challenges Faced, and What’s Next | Clinical Operations |
| 2:30 PM - 3:30 PM | Study Budget Negotiation: Tips & Tricks | Budgets |
| Tuesday, October 21, 2025 |
|---|
| 10:00 AM - 11:00 AM | Contracts TBD | Contracts |
| 10:00 AM - 11:00 AM | Making Sure Your MCA is Put into Practice | Billing Compliance |
| 11:30 AM - 12:30 PM | CTA Playbook Development | Contracts |
| 11:30 AM - 12:30 PM | AI & Medicare Coverage Analysis | Billing Compliance |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Strategic Growth & Portfolio Management in Clinical Operations | Clinical Operations |
| 1:00 PM - 2:00 PM | Are You Ready? Study Site Sponsor GCP Audits and Regulatory Inspections | Quality / Regulatory |
| 1:00 PM - 2:00 PM | Sponsor Perspective on Study Budgets & Negotiation | Budgets |
| 2:30 PM - 3:30 PM | Best Practices for Best Budgets | Budgets |
| 2:30 PM - 3:30 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | The 3 Cs of High-Performing Teams: Communication, Clarity & Culture | Clinical Operations |
| Wednesday, October 22, 2025 |
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| 10:00 AM - 11:00 AM | Research Compliance Basics: Anti-Kickback, Stark, and False Claims | Billing Compliance |
| 10:00 AM - 11:00 AM | Biological Specimens in Contracts | Contracts |
| 11:30 AM - 12:30 PM | AI & Recent Developments in Electronic Technologies and their impact on CTA terms | Contracts |
| 11:30 AM - 12:30 PM | Billing Compliance for Investigational Device Trials | Billing Compliance |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Creating an Audit-Ready Culture: Embedding Regulatory Compliance into Daily Site Operations | Quality / Regulatory |
| 1:00 PM - 2:00 PM | It Takes a Village: Engaging Participants, Families, and Caregivers in the Clinical Trial Journey | Clinical Operations |
| 1:00 PM - 2:00 PM | Panel Discussion: Managing a Successful Study Opportunity Pipeline | Budgets |
| 2:30 PM - 3:30 PM | AI & Clinical Trial Budgeting | Budgets |
| 2:30 PM - 3:30 PM | From Awareness to Action: Strategies for Inclusive and Accessible Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Quality/Regulatory TBD | Quality / Regulatory |
| Thursday, October 23, 2025 |
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| 10:00 AM - 11:00 AM | Insurance Dos & Don'ts in CTAs | Contracts |
| 10:00 AM - 11:00 AM | Medicare Reimbursement for Clinical Trials | Billing Compliance |
| 11:30 AM - 12:30 PM | Billing Compliance & Operations | Billing Compliance |
| 11:30 AM - 12:30 PM | Indemnification, Subject Injury & Limit of Liability | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Growing a Research Program & Staffing Challenges | Budgets |
| 1:00 PM - 2:00 PM | Aligning Goals, Sharing Accountability: Modern Collaboration in Clinical Trials | Clinical Operations |
| 1:00 PM - 2:00 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Addressing (& Preventing) Investigator Burnout | Budgets |
| 2:30 PM - 3:30 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Where Trust Begins: The Impact of Patient-Facing Site Staff in Clinical Trials | Clinical Operations |
| Friday, October 24, 2025 |
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| 10:00 AM - 11:00 AM | Advanced MCA & Stump the (Billing) Experts | Billing Compliance |
| 10:00 AM - 11:00 AM | Contracts TBD | Contracts |
| 11:30 AM - 12:30 PM | RBC Auditing & Clinical Documentation | Billing Compliance |
| 11:30 AM - 12:30 PM | Panel Discussion: CTA Stump the Experts | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Faster to First Dose: Accelerating Start-Up in Oncology Clinical Trials | Clinical Operations |
| 1:00 PM - 2:00 PM | Panel Discussion: Study Budgets - Pricing and Fair Market Value | Budgets |
| 1:00 PM - 2:00 PM | Quality/Regulatory TBD | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Panel Discussion: Review Framework for Clinical Research Involving AI | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Burnout & Boundaries: Protecting Your Peace While Making an Impact | Clinical Operations |
| 2:30 PM - 3:30 PM | Justifying the Value of Clinical Trials Research to C-Suite | Budgets |