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MAGI's Clinical Research vConference — Spring 2021

April 26–29 & May 3–6, 2021

Agenda

Monday, April 26
Plenary10:40 am - 10:55 am
Chairman's Opening Remarks

Plenary11:00 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 & Billing12:30 pm - 01:30 pm Solving the Budget Conundrum in Unsettled Times: A Panel Discussion
Can we solve the budget impasse?

Site Management12:30 pm - 01:30 pm The Evolving Site Landscape: A Panel Discussion
Powerful forces that are changing the world of research sites.

Special Topics12:30 pm - 01:30 pm Future Studies: How Leading Biopharmas are Reshaping Clinical Research: A Panel Discussion
Leading pharmas and CROs have a lot of influence over the future of clinical research

Contracts02:30 pm - 03:30 pm Feel the Power: Creating and Using a CTA Negotiation Playbook
Creating and using guidance and backup language.

Special Topics02:30 pm - 05:00 pm Modern Site Selection: A Panel Discussion
Who can you trust when the going gets tough?

Special Topics02:30 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 Compliance04:00 pm - 05:00 pm GCP & HSP Regulatory Fine Points: A Panel Discussion
Here's what the GCP & HSP regs really mean.

Site Management04:00 pm - 05:00 pm Ready, Set, Go! Accelerating Research Site Startup
Best practices for quick site startups.


Tuesday, April 27
Plenary10:40 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 & Billing12:30 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 & Billing02:30 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 Topics02:30 pm - 05:00 pm The Time Has Arrived: Patient Recruitment for Diversity & Inclusion
Innovations and best practices.

Special Topics 02:30 pm - 05:00 pm Topic TBD
Several options are under consideration.


Wednesday, April 28
Plenary10:40 am - 10:55 am
Chairman's Opening Remarks

Budgets & Billing11:00 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 Management11:00 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.

Special Topics11:00 am - 12:00 pm Topic TBD
Several options are under consideration.

Budgets & Billing12:30 pm - 01:30 pm Constructive Strategies & Tactics for Effective Budget Negotiation
How to speed negotiations along and achieve a mutually satisfactory result.

Regulatory Compliance12:30 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 & Billing02:30 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 Management02:30 pm - 03:30 pm Revealing Questions to Ask at Site Qualification Visits
Going beyond the checklist to learn the truth.

Quality & Risk Management02:30 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 Management04:00 pm - 05:00 pm Troubleshooting Underperforming Sites
Finding and fixing the problems.


Thursday, April 29
Plenary10:40 am - 10:55 am
Chairman's Opening Remarks

Contracts11:00 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 Compliance11:00 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 Management12:30 pm - 01:30 pm 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 & Billing02:30 pm - 03:30 pm Medicare Coverage Analysis Out of the Ordinary
Finding the limits of what Medicare will cover.

Contracts02:30 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 & Billing04:00 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
Plenary10:40 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.

Contracts12:30 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 Topic TBD
Several options are under consideration.

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.

Contracts02:30 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 Management02:30 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 Topics04:00 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
Plenary10:40 am - 10:55 am
Chairman's Opening Remarks

Budgets & Billing11:00 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.

Special Topics 11:00 am - 12:00 pm Topic TBD
Several options are under consideration.

Site Management12:30 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
Plenary10:40 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.

Contracts02:30 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.

Contracts04:00 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
Plenary10:40 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 Skills12:30 pm - 01:30 pm Streamlining & Simplifying Clinical Trial Processes
How to streamline and improve process quality.

Special Topics12:30 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 Skills02:30 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 COVID-19 Myths — Where We Go From Here? A Panel Discussion
COVID-19 has been full of surprises and there is still a lot of misinformation out there.

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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