| Monday, October 20, 2025 |
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| 10:00 AM - 11:00 AM | CTA Compromise Terms | Contracts |
| 10:00 AM - 11:00 AM | Block by Block: Building Research Billing into the Revenue Cycle | Billing Compliance |
| 11:30 AM - 12:30 PM | Clinical Trial Contracting with CROs, Balancing Legal Protection, Resources and Efficiency | Contracts |
| 11:30 AM - 12:30 PM | Billing Compliance & Medicare Coverage Analysis | Billing Compliance |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 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 | Developing a Site Budget from Protocol | Budgets |
| 1:00 PM - 2:00 PM | Devices Are Different: What Every Clinical Research Professional Needs to Know About Device Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Study Budget Negotiation: Tips & Tricks | Budgets |
| 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 | From Trials to Trust: The Evolution of Clinical Research | Quality / Regulatory |
| Tuesday, October 21, 2025 |
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| 10:00 AM - 11:00 AM | Making Sure Your MCA is Put into Practice | Billing Compliance |
| 10:00 AM - 11:00 AM | Accelerating CTA Negotiations For Faster Site Activation | Contracts |
| 11:30 AM - 12:30 PM | Accelerating Activation with AI: Budgets & Medicare Coverage Analysis | Billing Compliance |
| 11:30 AM - 12:30 PM | AI’s Impact on CTA Terms | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Sponsor Perspective on Study Budgets & Negotiation | Budgets |
| 1:00 PM - 2:00 PM | Clinical Trial Portfolio Management: Tools, Dashboards, and Strategic Execution | Clinical Operations |
| 1:00 PM - 2:00 PM | From Chaos to Control: Your Site Essential Records, Always Ready. | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Best Practices for Best Budgets | Budgets |
| 2:30 PM - 3:30 PM | Faster to First Dose: Accelerating Start-Up in Oncology Clinical Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Cultivating a Culture of Compliance in Challenging Circumstances: Institutional Strategies for HRPP Success | Quality / Regulatory |
| 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 | CTA Playbook Development | Contracts |
| 11:30 AM - 12:30 PM | Supercharge Your Site's Success: Billing Compliance for Investigational Device Trials | Billing Compliance |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 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 |
| 1:00 PM - 2:00 PM | Creating an Audit-Ready Culture: Embedding Regulatory Compliance into Daily Site Operations | Quality / Regulatory |
| 2:30 PM - 3:30 PM | From Exclusion to Inclusion: IRBs to Address Language Barriers in Research Leading FDA’s Diversity Inclusion Guidance | Quality / Regulatory |
| 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 |
| Thursday, October 23, 2025 |
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| 10:00 AM - 11:00 AM | Indemnification, Subject Injury & Limit of Liability Part I | Contracts |
| 10:00 AM - 11:00 AM | Medicare Reimbursement for Clinical Trials | Billing Compliance |
| 11:30 AM - 12:30 PM | Indemnification, Subject Injury & Limit of Liability Part 2 | Contracts |
| 11:30 AM - 12:30 PM | Billing Compliance & Operations | Billing Compliance |
| 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 | Defining a QA/Regulatory Role: Strengthening Oversight | Quality / Regulatory |
| 1:00 PM - 2:00 PM | Panel Discussion: Aligning Goals, Sharing Accountability: Modern Collaboration in Clinical Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Addressing (& Preventing) Investigator Burnout | Budgets |
| 2:30 PM - 3:30 PM | Where Trust Begins: The Impact of Patient-Facing Site Staff in Clinical Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Preparing Clinical Trial Sites for ICH E6(R3): Practical Guidance for Investigators | Quality / Regulatory |
| Friday, October 24, 2025 |
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| 10:00 AM - 11:00 AM | Insurance Dos & Don'ts in CTA Provisions | Contracts |
| 10:00 AM - 11:00 AM | Panel Discussion: Advanced MCA & Stump the (Billing) Experts | Billing Compliance |
| 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 | Panel Discussion: Study Budgets - Pricing and Fair Market Value | Budgets |
| 1:00 PM - 2:00 PM | The 3 Cs of High-Performing Teams: Communication, Clarity & Culture | Clinical Operations |
| 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 |
| 2:30 PM - 3:30 PM | Panel Discussion: Review Framework for Clinical Research Involving AI | Quality / Regulatory |