MAGI's Clinical Research vConference — Spring 2021
April 26–29 & May 3–6, 2021
Agenda
| Monday, April 26 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Plenary | 11:00 am - 12:00 pm | KEYNOTE: How COVID-19 Has Relaunched Clinical Research: A Panel Discussion The current pandemic is forcing changes and also inspiring innovations that will benefit clinical research for years to come. |
| Budgets & Billing | 12:30 pm - 01:30 pm | Solving the Budget Conundrum in Unsettled Times: A Panel Discussion Can we solve the budget impasse? |
| Site Management | 12:30 pm - 01:30 pm | The Evolving Site Landscape: A Panel Discussion Powerful forces that are changing the world of research sites. |
| Contracts | 02:30 pm - 03:30 pm | Feel the Power: Creating and Using a CTA Negotiation Playbook Creating and using guidance and backup language. |
| Special Topics | 02:30 pm - 05:00 pm | Modern Site Selection: A Panel Discussion Who can you trust when the going gets tough? |
| Special Topics | 02:30 pm - 05:00 pm | The Time Is Right: Virtual & Decentralized Trial Solutions Leading solution providers can help you decentralize and virtualize your clinical studies. (No contact hours) |
| Regulatory Compliance | 04:00 pm - 05:00 pm | GCP & HSP Regulatory Fine Points: A Panel Discussion Here's what the GCP & HSP regs really mean. |
| Site Management | 04:00 pm - 05:00 pm | Ready, Set, Go! Accelerating Research Site Startup Best practices for quick site startups. |
| Tuesday, April 27 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Clinical Operations & Project Management | 11:00 am - 12:00 pm | New Times, New Solutions: Key Challenges for Small Sponsors: A Panel Discussion How to conduct clinical trials with limited resources. |
| Regulatory Compliance | 11:00 am - 01:30 pm | Site Inspection Readiness: The Decisive GCP Challenge (Part 1) In this session, we will examine real-world examples of common inspection findings and the importance of proactive quality assurance, continuous quality improvement, study conduct according to GCP, and the development of appropriate CAPA’s so you can avoid and mitigate inspection findings. |
| Special Topics | 11:00 am - 01:30 pm | Diversity & Inclusion in Clinical Research Practical ways to apply diversity and inclusion principles in clinical studies and the workplace. |
| Budgets & Billing | 12:30 pm - 01:30 pm | Medicare Reimbursement for Clinical Trials: The Rules You’d Better Know & Consequences If You Don’t CMS rules for billing Medicare...and what can happen if you do not follow them. |
| Regulatory Compliance | 01:30 pm - 02:30 pm | Site Inspection Readiness: The Decisive GCP Challenge (Part 2) In this session, we will examine real-world examples of common inspection findings and the importance of proactive quality assurance, continuous quality improvement, study conduct according to GCP, and the development of appropriate CAPA’s so you can avoid and mitigate inspection findings. |
| Budgets & Billing | 02:30 pm - 03:30 pm | Putting Billing Compliance into Practice: The Work Is Worth the Payoff! This interactive program is designed for billing compliance professionals who deal with complex reimbursement issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover Medicare, Medicaid, Medicare Advantage, commercial health and insurance plans, regional CMS contractors, state-by-state laws, secondary payer strategies, physician vs. facility payments, inpatient issues, humanitarian device exemptions, electronic submissions, denials & appeals, overpayment returns, audit documentation, and information technology solutions. |
| Special Topics | 02:30 pm - 05:00 pm | The Time Has Arrived: Patient Recruitment for Diversity & Inclusion Innovations and best practices. |
| Wednesday, April 28 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Budgets & Billing | 11:00 am - 12:00 pm | Hidden Costs that Destroy Site Profitability What costs do sites and sponsors incur that are not in study budgets and not "the cost of doing business"? |
| Quality & Risk Management | 11:00 am - 01:30 pm | Risky Business: Assessing, Characterizing & Managing Risk in Clinical Research To understand a risk, you need to understand severity, probability, contingencies and whole lot more. |
| Regulatory Compliance | 11:00 am - 11:25 am | Sponsored Session: SkyIRIS Software to Manage Single IRB Envision a secure network where institutions can submit their research to other institutions and maintain a level of local oversight. |
| Budgets & Billing | 12:30 pm - 01:30 pm | Constructive Strategies & Tactics for Effective Budget Negotiation How to speed negotiations along and achieve a mutually satisfactory result. |
| Regulatory Compliance | 12:30 pm - 01:30 pm | Would You Approve This Study? Study Approvals at the Edge IRB reviews of studies right in the middle of the gray area. |
| Budgets & Billing | 02:30 pm - 05:00 pm | Budget Development & Negotiation for Investigative Sites Effective budget negotiation requires preparation: knowing your costs and developing the infrastructure and methodology to consistently maximize revenues. Demonstrate value and conduct effective negotiations. Workshop is also illuminating for research sponsors and CROs. Bring your laptop for the budgeting exercise. |
| Clinical Operations & Project Management | 02:30 pm - 03:30 pm | Revealing Questions to Ask at Site Qualification Visits Going beyond the checklist to learn the truth. |
| Quality & Risk Management | 02:30 pm - 05:00 pm | Powerful Quality Management Systems for Sponsors, Sites and CROs Learn how to use interwoven processes and tools, such as process mapping, gap analysis, quality metrics, risk management, CAPA, and procedural documents and tools. |
| Clinical Operations & Project Management | 04:00 pm - 05:00 pm | Troubleshooting Underperforming Sites Finding and fixing the problems. |
| Thursday, April 29 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Contracts | 11:00 am - 01:30 pm | Details Matter: Dissecting a Clinical Trial Agreement (Part 1) Sometimes the wording does make a difference. We will examine 50 key points in MAGI’s standard clinical trial agreement template. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario… In the first hour, we will provide an introduction to CTAs. After that, the material will be more advanced. |
| Regulatory Compliance | 11:00 am - 01:30 pm | Hot Topics in Regulatory Compliance Emergency use authorizations, clinicaltrials.gov. laboratory developed tests, and institutional biosafety committees. This advanced program is designed for clinical research professionals with responsibility for regulatory compliance. |
| Site Management | 12:30 pm - 01:30 pm | Sponsored Session: Integrated Workflows: Empowering Your Day with Connected Tech Are you working across 20 systems? Remembering 80 passwords? Learn how to harness integrated tech to avoid digital fatigue, duplication & wasted time. |
| Budgets & Billing | 02:30 pm - 03:30 pm | Medicare Coverage Analysis Out of the Ordinary Finding the limits of what Medicare will cover. |
| Contracts | 02:30 pm - 05:00 pm | Details Matter: Dissecting a Clinical Trial Agreement (Part 2) Sometimes the wording does make a difference. We will examine 50 key points in MAGI’s standard clinical trial agreement template. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario… |
| Regulatory Compliance | 02:30 pm - 05:00 pm | Misconduct: Minimization, Detection, Investigation & Enforcement A systematic approach. True stories! |
| Budgets & Billing | 04:00 pm - 05:00 pm | Fair Market Value in Industry-Sponsored Clinical Research Budgets There's a right way to use it...and a wrong way. |
| Monday, May 3 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Plenary | 11:00 am - 12:00 pm | KEYNOTE: Diversity & Inclusion in Action: A Panel Discussion Diversity and inclusion were hot topics last year. What can we do now to make them a reality? |
| Clinical Operations & Project Management | 12:30 pm - 01:30 pm | Setting Your Study Team Up for Success Define scope, resources, timeline, expectations, etc., before you start. |
| Contracts | 12:30 pm - 01:30 pm | Risky Business: A CTA Case Study Involving Subject Injury & Indemnification Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first. |
| Special Topics | 12:30 pm - 01:30 pm | Risky Business: A CTA Case Study Involving Subject Injury & Indemnification Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first. |
| Special Topics | 01:30 pm - 02:30 pm | Are You Hearing Us? Are We Hearing You? A Panel Discussion What sponsors and CROs need to understand about sites...and what sites need to understand about sponsors and CROs. |
| Contracts | 02:30 pm - 05:00 pm | Into the Abyss: Subject Injury and Indemnification A deep dive into the subject injury and indemnification sections of clinical trial agreements. |
| Quality & Risk Management | 02:30 pm - 03:30 pm | Look Out! Remote Site Governance in the Age of COVID-19 How sponsors and CROs can ensure regulatory and protocol compliance with minimal site visits. |
| Site Management | 02:30 pm - 03:30 pm | How Should Sites Compensate & Contract with Investigators? What is legal, fair and motivating? How should RVUs be handled? |
| Special Topics | 04:00 pm - 05:00 pm | Sticking Points in Decentralizing Clinical Trials: A Panel Discussion Now that decentralization is well underway, where is it running into problems? |
| Tuesday, May 4 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Budgets & Billing | 11:00 am - 12:00 pm | Sites Literally Can't Wait to Get Paid Systems, processes, tips & tricks for making and obtaining timely payments. |
| Clinical Operations & Project Management | 11:00 am - 01:30 pm | Clinical Project Management: A Skills-Based Workshop (Part 1) This skills-based project management workshop will provide a solid foundation for managing projects, work schedules, risks, timelines, communications and resources, as well as utilizing metrics and key performance indicators to monitor and control your projects for clinical research managers, new project managers, line managers, and others responsible for clinical research project success. |
| Regulatory Compliance | 11:00 am - 01:30 pm | Recent Developments in Subject Data Privacy & Security...and How to Address Them Ongoing changes in privacy and security laws and regulations. Pitfalls and best practices. |
| Site Management | 12:30 pm - 01:30 pm | Run Your Site Like a Business Making the hard decisions needed to survive and grow. |
| Clinical Operations & Project Management | 02:30 pm - 05:00 pm | Clinical Project Management: A Skills-Based Workshop (Part 2) This skills-based project management workshop will provide a solid foundation for managing projects, work schedules, risks, timelines, communications and resources, as well as utilizing metrics and key performance indicators to monitor and control your projects for clinical research managers, new project managers, line managers, and others responsible for clinical research project success. |
| Site Management | 02:30 pm - 05:00 pm | Master Class: Site Management Innovations & Best Practices for Institutional Sites Integrating CTMS, EMR, IRB, subject payment, and general business systems; protocol reviews by physician and nurse manager committees; the "circle of accountability"; and integrating hospitals and private practices into a health system's clinical research program. |
| Site Management | 02:30 pm - 05:00 pm | Master Class: Site Management Innovations & Best Practices for Independent Sites How best to address tough challenges in managing independent sites. |
| Wednesday, May 5 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Contracts | 11:00 am - 01:30 pm | Cyberliability: Procrastination Is Not a Winning Strategy EDC, remote site monitoring, and other digital interactions that can expose you to incalculable risks. |
| Management & Professional Skills | 11:00 am - 01:30 pm | Transform Your Role from Manager to Leader Change your mindset. Change your skills. |
| Site Management | 11:00 am - 12:00 pm | How Are Marketing & Business Development for Sites Changing? A Panel Discussion Getting the word out and the studies in. |
| Special Topics | 12:30 pm - 01:30 pm | Workshop: Mind Full or Mindful? Finding Space in a 24/7 World Mindfulness, an excellent antidote to the stresses of modern life, is the art of paying attention to the present moment and can be brought to any moment in life. |
| Contracts | 02:30 pm - 03:30 pm | 12 Key Intellectual Property Provisions in CTAs Inventions, ownership, technology transfer, and common areas of conflict. |
| Management & Professional Skills | 02:30 pm - 03:30 pm | Conflict Resolution: Address Difficult Situations Before They Get Out of Hand Practical methods to resolve conflicts and generate a positive outcome. |
| Special Topics | 02:30 pm - 03:30 pm | The "Tiny Details" that Can Wreak Havoc with a Protocol What sponsors, sites and CROs should look for in a protocol. |
| Contracts | 04:00 pm - 05:00 pm | Gotcha! Critical Words & Phrases in Clinical Trial Agreements A few words can change everything. |
| Management & Professional Skills | 04:00 pm - 05:00 pm | 6 Steps to Overcome Resistance to Change...Today How to get the sand out of the gears. |
| Special Topics | 04:00 pm - 05:00 pm | What Really Happened? Assessing SAE Causation The nine factors in determined the causation of serious adverse event. |
| Thursday, May 6 |
| Plenary | 10:40 am - 10:55 am | Chairman's Opening Remarks |
| Budgets & Billing | 11:00 am - 12:00 pm | Supporting Medicare Claims with Source Documentation & Other Records How to submit accurate and defensible claims. |
| Special Topics | 11:00 am - 12:00 pm | Seamless, Paperless Clinical Research Studies Clinical research is eliminating paper and connecting technologies so they can talk to each other. |
| Special Topics | 11:00 am - 01:30 pm | Medical Device Clinical Research: Hot Topics, Regulatory Updates & New Normals (Part 1) Update on Europe's MDR; U.S. regulatory update; what’s new with CDRH and CMS guidance, policy and clearances; and post-market surveillance. |
| Management & Professional Skills | 12:30 pm - 01:30 pm | Streamlining & Simplifying Clinical Trial Processes How to streamline and improve process quality. |
| Special Topics | 12:30 pm - 01:30 pm | Apply Health Literacy Strategies to Clarify Your Study Communications Engage participants by communicating complex research concepts in plain language. |
| Management & Professional Skills | 02:30 pm - 03:30 pm | Effective Writing Deliver your message clearly, concisely and coherently. |
| Management & Professional Skills | 02:30 pm - 05:00 pm | How to Achieve Exponential Performance With Your Team Leaders, colleagues and sponsors: High performance teamwork drives higher-quality outcomes. |
| Special Topics | 02:30 pm - 05:00 pm | Medical Device Clinical Research: Hot Topics, Regulatory Updates & New Normals (Part 2) This interactive program is designed for medical device professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. |
| Special Topics | 04:00 pm - 05:00 pm | Getting Unlost in the COVID-19 Vaccine Landscape The COVID-19 outlook will only get more complicated. What does that mean for clinical research? |
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