| Monday, October 21, 2024 |
|---|
| 10:00 AM - 11:00 AM | Clinical Trial Agreements (CTA) 101 | Contracts |
| 10:00 AM - 11:00 AM | Billing Compliance: Foundations Class | Billing Compliance |
| 11:30 AM - 12:30 PM | How to Explain Study Costs & Billing to Patients | Billing Compliance |
| 11:30 AM - 12:30 PM | What's Reasonable? How to Adjust Templates and Redline Approach for Faster CTA Negotiations | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Accelerating Study Start-up: Strategies to Overcome Common Hurdles | Clinical Operations |
| 1:00 PM - 2:00 PM | Tools and Techniques for Study Budget Negotiation Prep | Budgets |
| 1:00 PM - 2:00 PM | Life Cycle of Essential Documents and Tools to Maintain the Site File | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Change Management in Clinical Trials | Clinical Operations |
| 2:30 PM - 3:30 PM | Hidden Costs in Clinical Trials: Identifying & Negotiating | Budgets |
| 2:30 PM - 3:30 PM | Operating in a World of Grey for Non-interventional/Real World Evidence Studies | Quality / Regulatory |
| Tuesday, October 22, 2024 |
|---|
| 10:00 AM - 11:00 AM | Creating the Medicare Coverage Analysis | Billing Compliance |
| 10:00 AM - 11:00 AM | Clinical Trial Agreements (CTA) 102 | Contracts |
| 11:30 AM - 12:30 PM | Oncology Trials: Budget & Billing Best Practices | Billing Compliance |
| 11:30 AM - 12:30 PM | Nonstandard Agreements in Research | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Risk Management: Developing and Executing a Plan | Clinical Operations |
| 1:00 PM - 2:00 PM | Sponsor Perspective: Challenges of Creating Study Budgets | Budgets |
| 1:00 PM - 2:00 PM | FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door! | Quality / Regulatory |
| 2:30 PM - 3:30 PM | How to Make Your Site Attractive to Sponsors | Clinical Operations |
| 2:30 PM - 3:30 PM | Are Sites Chasing Money or Chasing Tails? Best Practices for Site Payments | Budgets |
| 2:30 PM - 3:30 PM | FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door! | Quality / Regulatory |
| Wednesday, October 23, 2024 |
|---|
| 10:00 AM - 11:00 AM | Artificial Intelligence in CTA Negotiation and Management | Contracts |
| 10:00 AM - 11:00 AM | Advanced Research Billing Compliance Topics | Billing Compliance |
| 11:30 AM - 12:30 PM | Navigating Multi-Agency Compliance in Clinical Research: DOJ, OIG, ORI, and State Law Considerations | Billing Compliance |
| 11:30 AM - 12:30 PM | Collaboration Over Confrontation: CTA Negotiation Tips & Tricks | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | The (new) New Media: How Social and Online Advertising has Shifted for Patient Recruitment | Clinical Operations |
| 1:00 PM - 2:00 PM | ICH E6(R3) Countdown: Insights on Readiness, Risk, and Collaboration | Quality / Regulatory |
| 1:00 PM - 2:00 PM | Is it All Just Copy & Paste? (Pros & Cons of Repeat Business Between Sponsors & Sites) | Budgets |
| 2:30 PM - 3:30 PM | Innovative Methods of Assessing Protocol & Site Feasibility | Budgets |
| 2:30 PM - 3:30 PM | Determinants of Advanced Technology Solutions: eConsent, AI & more! | Clinical Operations |
| Thursday, October 24, 2024 |
|---|
| 10:00 AM - 11:00 AM | Cybersecurity | Contracts |
| 10:00 AM - 11:00 AM | Medical Device Trials: Similarities & IMPORTANT Differences | Billing Compliance |
| 11:30 AM - 12:30 PM | Patient Reimbursements: Regulations, Ethics, and Real World Challenges | Billing Compliance |
| 11:30 AM - 12:30 PM | Clinical Trial Agreements (CTA) 103 | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Using AI for Informed Consent | Clinical Operations |
| 1:00 PM - 2:00 PM | From Trials to Trust: The Evolution of Clinical Research | Quality / Regulatory |
| 1:00 PM - 2:00 PM | Site Metrics: What Are You Measuring | Budgets |
| 2:30 PM - 3:30 PM | Study Pipelines: Identifying and Securing Study Opportunities | Budgets |
| 2:30 PM - 3:30 PM | Site Feasibility and the Importance of Stakeholder Engagement | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Addressing Principal Investigator Shortages: How to Leverage Advanced Practice Practitioners (APPs) | Clinical Operations |
| Friday, October 25, 2024 |
|---|
| 10:00 AM - 11:00 AM | Auditing and Monitoring | Billing Compliance |
| 10:00 AM - 11:00 AM | Into the Abyss: Recent Developments in Subject Data Privacy & Security… And How to Address Them | Contracts |
| 11:30 AM - 12:30 PM | MCA Support Services: Buy or Build? | Billing Compliance |
| 11:30 AM - 12:30 PM | Stump the Experts: Contracting and CTA Language | Contracts |
| 12:30 PM - 1:00 PM | Lunch Break | |
| 1:00 PM - 2:00 PM | Fair Market Value in the Age of Price Transparency | Budgets |
| 1:00 PM - 2:00 PM | FDA Diversity Action Plan | Clinical Operations |
| 1:00 PM - 2:00 PM | Building Blocks to the Proper Informed Consent | Quality / Regulatory |
| 2:30 PM - 3:30 PM | Selling Your Leadership on the Value of Clinical Trials Research | Budgets |