MAGI's Clinical Research Conference - 2016 East

Conference Program

Tracks are identified in the left column. There is also a “virtual” Quality track. Topics and timing may change.

 

Sunday, May 1

08:30am - 09:30amRegistration, Networking & Light Breakfast
09:30am - 12:00pmWorkshops:
Regulatory Compliance(W190a) Master Class: Good Clinical Practice and Inspection Readiness (Part 1)
This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. (Related sessions: W190b)
Contracts(W191a) Dissecting a Clinical Trial Agreement (Part 1)
Sometimes the wording does make a difference. We will examine 50 key points in MAGI’s model clinical trial agreement. 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.
Site Operations(W851a) Foundation Class: Site Management Fundamentals (Part 1)
Operate your research site like a business. Effective management of operations (processes and quality), personnel, customers (sales, negotiations, communications), technology and finances.
Site Operations(W852a) Master Class: Site Management Innovation (Part 1)
Thought leaders will present their perspectives and innovations to address long-standing and emerging challenges. We will then work together to identify and develop best practices in three areas: leveraging metrics to drive performance, innovative site management structures & practices, and quality management systems. (Related sessions: E120, E256, E322, E337, E379, W419, W852b)
Budgets & Billing(W853a) Foundation Class: Billing Compliance (Part 1)
This interactive program will provide an introduction to billing compliance. We will cover the basics of Medicare clinical trial policies, coverage analysis, fraud and abuse, and the Stark and anti-kickback laws. For the rest of the day, the material will be more advanced. (Related sessions: B118, B208, B259, B468, W853b)
Site Operations(W857a) Master Class: Oncology Clinical Research (Part 1)
This advanced, interactive program is designed for clinical research professionals dealing with the complex challenges peculiar to oncology. We will cover CTCAE & RECIST, tissue banking and biospecimens, and NCTN vs. industry trials from a community perspective. (Related sessions: C361, W857b)
Site Operations(W858a) Master Class: Patient Recruiting & Retention (Part 1)
This interactive program is designed for clinical research professionals with responsibility for subject recruiting. We will cover trial awareness and promotions, community outreach strategies, special populations, inpatient recruiting and EMRs, and getting the most from a central recruitment program.
Special Topics(W860a) Master Class: Risk Management for Sponsors, Sites and CROs (Part 1)
In this interactive workshop, we will explore processes and tools for risk management, such as risk-based monitoring, process mapping, gap analysis, and protocol risk analysis.
Regulatory Compliance(W873a) Master Class: Regulatory Compliance (Part 1)
The year in review, HSP non-compliance, and fair market value and anti-kickback.
Sponsor Operations(W875a) Foundation Class: 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, timelines and resources for clinical research managers, new project managers, line managers, and those responsible for clinical research project success.

12:00pm - 01:30pmEnjoy the town (no lunch provided by MAGI)
12:00pm - 05:15pmRegistration
01:30pm - 04:45pmWorkshops:
Regulatory Compliance(W190b) Master Class: Good Clinical Practice and Inspection Readiness (Part 2)
This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. (Related sessions: W190a)
Contracts(W191b) Dissecting a Clinical Trial Agreement (Part 2)
Sometimes the wording does make a difference. We will examine 50 key points in MAGI’s model clinical trial agreement. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario…
Site Operations(W851b) Foundation Class: Site Management Fundamentals (Part 2)
Operate your research site like a business. Effective management of operations (processes and quality), personnel, customers (sales, negotiations, communications), and finances.
Site Operations(W852b) Master Class: Site Management Innovation (Part 2)
Thought leaders will present their perspectives and innovations to address long-standing and emerging challenges. We will then work together to identify and develop best practices in three areas: leveraging metrics to drive performance, innovative site management structures & practices, and quality management systems. (Related sessions: E120, E256, E322, E337, E379, W419, W852a)
Budgets & Billing(W853b) Master Class: Billing Compliance (Part 2)
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 discuss using coverage analysis to facilitate regulatory compliance with respect to the contract, budget and informed consent, necessary oversight, and how to address issues that can arise. (Related sessions: B118, B208, B259, B468, W853a)
Site Operations(W857b) Master Class: Oncology Clinical Research (Part 2)
This advanced, interactive program is designed for clinical research professionals dealing with the complex challenges peculiar to oncology. We will cover patient recruiting, informed consent, biomarkers and personalized medicine. (Related sessions: C361, W857a)
Site Operations(W858b) Master Class: Patient Recruiting & Retention (Part 2)
This interactive program is designed for clinical research professionals with responsibility for subject recruiting. We will cover engaging patients with study websites, digital and social media strategies, telephone screening optimization, and using SMS messaging for recruitment and retention.
Special Topics(W860b) Master Class: Risk Management for Sponsors, Sites and CROs (Part 2)
In this interactive workshop, we will explore processes and tools for risk management, such as risk-based monitoring, process mapping, gap analysis, and protocol risk analysis.
Regulatory Compliance(W873b) Master Class: Regulatory Compliance (Part 2)
Flexibility in the Uniform Guidance, research misconduct, and the NPRM.
Sponsor Operations(W875b) Foundation Class: 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, timelines and resources for clinical research managers, new project managers, line managers, and those responsible for clinical research project success.

01:30pm - 04:45pm(X906b) Working Group: Refining MAGI's New CTA Template
We will refine MAGI's new 11-page CTA template and extend it to CRO/site contracts. Participation is open to CTA professionals who can contribute to the group's work. Sign up by April 21.
04:30pm - 05:30pmExhibit Hall Open - Meet the Puppies!
Yes, real puppies, and they like you a lot.
05:15pm - 06:45pmWorkshops:
Special Topics(W188) Public Speaking 2.0: Stage Presence
From business meetings to industry conferences, clinical research offers many opportunities for public speaking. This interactive workshop will focus on stage presence: authenticity, vocalization, animation and engagement.
Site Operations(W419) Clinical Trial Offices: Challenges and Best Practices
Academic and medical center challenges, solutions, and best practices. (Related sessions: W852a, W852b)
Special Topics(W820) Challenges in Conducting Medical Device Trials
Practical regulatory, site and sponsor tips for conducting device trials. (Related sessions: A260, C171)
Budgets & Billing(W853c) Master Class: Billing Compliance (Part 3)
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 discuss using coverage analysis to facilitate regulatory compliance with respect to the contract, budget and informed consent, necessary oversight, and how to address issues that can arise.
Regulatory Compliance(W870) IRB Best Practices
Overcoming challenges with a lean IRB that achieves results.

07:00pm - 08:00pmInformal Get-Together at Bar 10 in the Westin
Relax with old friends...and new ones (drink coupon on attendee "Options" page). Hosted by Quorum Review IRB.

Monday, May 2

07:00am - 01:30pmExhibit Hall Open (Monday morning through early afternoon)
07:00am - 08:00amRegistration, Networking & Light Breakfast
08:00am - 08:45am(P101) Chairman's Opening Remarks
How to get the most out of the conference.
08:45am - 10:00am(P134) FDA in the 21st Century: A Panel Discussion
New therapies, new technologies, new priorities, new rules, and their impact on clinical research. (Starts at 8:40 AM)
10:00am - 10:30amMonday Morning Networking Break
10:30am - 12:15pmTracks:

Contracts10:30am - 12:15pm(A104) Managing Risk with Contracts: Informed Consent, Subject Injury, Insurance & Indemnification
Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first. (Related sessions: A108, A202, A339, B390, W236)

Budgets & Billing10:30am - 11:15am(B222) Debate: Site Budgets Are Fair
A debate about whether sites are fairly compensated for their services. (Related sessions: A202, B161, B247, B390, E322, W193)
11:30am - 12:15pm(B471) The Budget Conundrum: A Panel Discussion
Can we solve the budget impasse?

Regulatory Compliance10:30am - 11:15am(C825) Healthcare Reform Update: Opportunities and Challenges
The practical implications for research sponsors, sites and CROs. (Related sessions: C326, F398)
11:30am - 12:15pm(C525) Emerging Issues in Human Subjects Protection
Unsolved problems that need to be solved.

Sponsor Operations10:30am - 11:15am(D592) The Rise of Virtual Sponsors
Radical outsourcing and SaaS make drug and device companies more valuable...if they do it right.
11:30am - 12:15pm(D543) Innovative Methods for Assessing Protocol Feasibility
Protocol feasibility assessment - doing it right the first time.

Site Operations10:30am - 11:15am(E312) Quality Systems for Research Sites
SOPs, training programs, and self-monitoring systems that ensure human subjects protection and data quality. (Related sessions: C138, D450, E120, W239)
11:30am - 12:15pm(E120) Metrics for Site Management & Business Development
What metrics are useful internally and externally. (Related sessions: C138, D450, E256, E312, E322, E337, E379, W239, W852a, W852b)

Special Topics10:30am - 11:15am(F573) Direct from the Participant: Patient Reported Outcomes and Digital Devices
Cutting-edge patient-reported data collection, wearable and electronic devices, innovative reporting methods.
11:30am - 12:15pm(F490) Patient-Centric Clinical Trials: A Panel Discussion
What's desirable and what's practical.

12:15pm - 01:30pmLunch: Birds of a Feather
Talk with people who share your interests.
01:30pm - 03:15pmTracks:

Contracts01:30pm - 03:15pm(A339) Intellectual Property Provisions in CTAs
Inventions, ownership, technology transfer, and common areas of conflict (Related sessions: A104, A108, A202, B390, W236)

Budgets & Billing01:30pm - 02:15pm(B247) Hidden Costs for Sites and Sponsors
What costs do sites and sponsors incur that are not in study budgets and not "the cost of doing business"? (Related sessions: A202, B161, B222, B390, E322, W193)
02:30pm - 03:15pm(B842) Site Overhead Costs: Are They Really that Big?
How to calculate overhead costs to price services correctly.

Regulatory Compliance01:30pm - 02:15pm(C138) Regulatory Inspections of Research Sites
What to expect, what to do, and what not to do. (Related sessions: C293, D450, E120, E312, W239)
02:30pm - 03:15pm(C533) Regulatory Issues with Mobile Technology
Privacy, security and what constitutes a medical device.

Sponsor Operations01:30pm - 02:15pm(D311) Lessons Learned: Sponsor, Site and CRO Study Post Mortems
Let's not make the same mistakes again.
02:30pm - 03:15pm(D844) Behind the Scenes: How Site Selection Really Works
How do I get on preferred site lists? How much say does the study manager have? Do site blacklists really exist? These questions answered and more!

Site Operations01:30pm - 02:15pm(E337) Marketing & Business Development for Sites
Getting the word out and the studies in. (Related sessions: E120, E256, E322, E379, W852a, W852b)
02:30pm - 03:15pm(E587) Modernizing Your Site
Processes, technology and more!

Special Topics01:30pm - 02:15pm(F477) Four Things We Just Can't Seem to Get Right
Let's identify the problems and figure out some solutions.
02:30pm - 03:15pm(F591) Shared Services: Inhouse Outsourcing
Retaining control and improving efficiency.

03:15pm - 07:00pmExhibit Hall Open (Monday afternoon through evening)
03:15pm - 03:45pmMonday Afternoon Networking Break
03:45pm - 05:30pmTracks:

Contracts03:45pm - 04:30pm(A202) Sensible Payment Terms in CTAs
Ten sensible payment terms you need to know. (Related sessions: A104, A108, A339, B161, B222, B247, B390, E322, W193, W236)
04:45pm - 05:30pm(A260) Just Medical Devices: A Moderated Discussion
Just for people conducting clinical research with medical devices: challenges and solutions. (Related sessions: C171, W820)

Budgets & Billing03:45pm - 04:30pm(B161) Constructive Tactics for Effective Budget Negotiation
Constructive tactics for reaching agreement. (Related sessions: A202, B222, B247, B390, E322, W193)
04:45pm - 05:30pm(B390) Just Budgets: A Moderated Discussion
Just for people who negotiate budgets: challenges and solutions. (Related sessions: A104, A108, A202, A339, B161, B222, B247, E322, W193, W236)

Regulatory Compliance03:45pm - 04:30pm(C590) Would You Approve This? Study Approvals at the Edge
IRB reviews of studies right in the middle of the gray area.
04:45pm - 05:30pm(C361) Just Oncology: A Moderated Discussion
Just for people conducting clinical research in oncology: challenges and solutions. (Related sessions: W857a, W857b)

Sponsor Operations03:45pm - 04:30pm(D589) Powering Your TMF for Inspection Readiness
Why you can expect a 483 or critical finding.
04:45pm - 05:30pm(D363) Just Sponsors: A Moderated Discussion
Just for study sponsors: challenges and solutions.

Site Operations03:45pm - 04:30pm(E219) Accelerating Study Startup
Working together to save time. (Related sessions: E256, W194, W204)
04:45pm - 05:30pm(E364) Just Sites: A Moderated Discussion
Just for study sites: challenges and solutions.

Special Topics03:45pm - 04:30pm(F588) Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation
The cure is much worse than the disease.
04:45pm - 05:30pm(F365) Just International: A Moderated Discussion
Just for people conducting international clinical research: challenges and solutions.

05:30pm - 07:00pm(X997) Zenith Reception in Exhibit Hall
Hosted by Schulman Associates IRB

Tuesday, May 3

07:30am - 01:45pmExhibit Hall Open (Tuesday morning through early afternoon)
07:30am - 08:30amRegistration, Networking & Light Breakfast
08:30am - 10:15amTracks:

Contracts08:30am - 09:15am(A579) Those Devilish Details: Key Words & Phrases in Clinical Trial Agreements
A few words can change everything.
09:30am - 10:15am(A108) Don’t Forget the Other Contract Terms
There’s a reason we call it “boilerplate.” Ten contract clauses you need to understand. (Related sessions: A104, A202, A339, B390, W236)

Budgets & Billing08:30am - 09:15am(B593) PCORI Grant Submissions and Negotiations
Big opportunity if you do it right.
09:30am - 10:15am(B112) Sponsor Payments to Sites: How Long Does It Really Take?
New data on collection timelines. How sites can collect payments on time.

Regulatory Compliance08:30am - 09:15am(C293) Regulatory Myths: A Panel Discussion
Common "wisdom" about what the rules don't actually say. (Related sessions: C138)
09:30am - 10:15am(C520) Jeopardy! The Human Subjects Protection Edition with Audience Participation
You think you know the answers? Teams, comprised of audience members, will compete in this lively, interactive session.

Sponsor Operations08:30am - 10:15am(D450) Risk-Based & Centralized Site Monitoring: Implementation
How to put the theory into practice. (Related sessions: C138, E120, E312, W239)

Site Operations08:30am - 09:15am(E352) Harnessing the Power of Digital and Social Media to Drive Patient Recruitment
Proven tactics for recruiting subjects; social listening.
09:30am - 10:15am(E315) Recruiting Diverse Study Participants: A Panel Discussion
Innovative methods for accessing minority populations.

Special Topics08:30am - 10:15am(F398) The Sunshine Act (Open Payments): Challenges, Solutions, and Interplay With Other Issues
Is Your Outlook Sunny or Cloudy? (Related sessions: C326, C825)

10:15am - 10:45amTuesday Morning Networking Break
10:45am - 12:30pmTracks:

Contracts10:45am - 11:30am(A467) CTA Sticking Points
Moving through the toughest points in a CTA negotiation.
11:45am - 12:30pm(A571) The New MAGI CTA Template
MAGI wrote the CTA bible and has now distilled it down to an 11-page model CTA template.

Budgets & Billing10:45am - 11:30am(B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare. (Related sessions: B118, B259, B468, W853a, W853b)
11:45am - 12:30pm(B118) Medicare Billing Compliance in Practice
Hard lessons learned; process & infrastructure to decrease institutional risk. (Related sessions: B208, B259, B468, W853a, W853b)

Regulatory Compliance10:45am - 12:30pm(C326) Recent Developments in Subject Data Privacy & Security
HIPAA, CLIA and data management security issues. (Related sessions: C825, F398)

Sponsor Operations10:45am - 11:30am(D568) Big Hat, Little Hat: Working with a Partner that is Much Bigger or Smaller than You
How to work with a partner that is not your size.
11:45am - 12:30pm(D594) Study Simulation: From Computer to Exam Room
Model your study to estimate risk factors...or try a visit to see what really happens.

Site Operations10:45am - 11:30am(E322) Financial Management of Research Sites
Improving the bottom line. (Related sessions: A202, B161, B222, B247, B390, E120, E256, E337, E379, W193, W852a, W852b)
11:45am - 12:30pm(E256) Site Operations Challenges: Do You Really Expect Us to Do This? A Panel Discussion
What happens when a sponsor or a CRO makes "unreasonable" demands on a site? (Related sessions: E120, E219, E322, E337, E379, W194, W204, W852a, W852b)

Special Topics10:45am - 11:30am(F494) The New World of Transparency for Clinical Trial Results
What information can/should we share -- and how?
11:45am - 12:30pm(F512) Paperless Clinical Trials
Moving to an all-digital environment.

12:30pm - 01:45pmLunch: States & Regions
Talk with people from your geographical area.
01:15pm - 02:30pm(X984) Clinical Research Contract Professional (CRCP) Certification Exam (1)
MAGI offers certification for clinical research contract professionals. Certification is available only at MAGI’s Clinical Trial Agreements and Budgets conferences. Attending the conference is excellent preparation for the certification exam. The exam is optional and open to everyone. Also offered on Wednesday. There is an additional $369 fee to take the exam. More information.
01:45pm - 02:30pmTracks:

Contracts01:45pm - 02:30pm(A478) Efficient Contract & Budget Negotiation
Saving time and energy at the front end.

Budgets & Billing01:45pm - 02:30pm(B259) Medicare Coverage Analysis Out of the Ordinary
Finding the limits of what Medicare will cover. (Related sessions: B118, B208, B468, W853a, W853b)

Regulatory Compliance01:45pm - 02:30pm(C171) Advanced Topics in Medical Device Regulation
Current issues for sites and sponsors. (Related sessions: A260, W820)

Sponsor Operations01:45pm - 02:30pm(D552) Obtaining Site Feedback on CROs: A New Process for the Industry
A questionnaire and process for collecting and assessing site perspectives on your CROs.

Site Operations01:45pm - 02:30pm(E379) Clinical Research at Community Hospitals: A Panel Discussion
Making clinical research work at community hospitals. (Related sessions: E120, E256, E322, E337, W852a, W852b)

Special Topics01:45pm - 02:30pm(F795) From Contact to Consent
Leveraging technology to reach more patients and enhance their study experience. (Contact hours not available)

02:30pm - 04:00pmExhibit Hall Open (Tuesday afternoon)
02:45pm - 03:30pmTracks:

Contracts02:45pm - 03:15pm(A215) Does Your Insurance Policy Cover This?
What is and is not covered may surprise you.

Budgets & Billing02:45pm - 03:30pm(B468) Anti-Kickback, Stark and False Claims
More ways to run afoul of the feds. (Related sessions: B118, B208, B259, W853a, W853b)

Regulatory Compliance02:45pm - 03:30pm(C570) Fair and Efficient Investigations into Noncompliance and Research Misconduct
Minimizing the legal and regulatory risks.

Sponsor Operations02:45pm - 03:30pm(D538) Clinical Trials for Small Sponsors: A Panel Discussion
How to conduct clinical trials with limited resources.

Site Operations02:45pm - 03:30pm(E294) How Should Sites Compensate Investigators?
What is legal, fair and motivating? How should RVUs be handled?

Special Topics02:45pm - 03:30pm(F793) Shared Sponsor/Site Processes
Leveraging technology to enhance the efficiency of sponsor/site processes. (Contact hours not available)

03:30pm - 04:15pmTuesday Late Afternoon Networking Break
Exhibitor creativity...you be the judge!
04:15pm - 05:15pm(P124) Stump the Experts
Clinical trial experts will try to answer your most perplexing questions.
05:15pm - 06:15pmInformal Get-Together at underFIRE -- It's Taco Night!
Relax with old friends...and new ones (cash bar)

Wednesday, May 4

07:15am - 08:00amRegistration, Networking & Light Breakfast
08:00am - 12:00pmWorkshops:
Site Operations(W184) The Research Site Toolbox
We will present forms, checklists and other tools that make life easier. We will also work together to refine some of the 150+ standard tools that MAGI has posted on its website.
Budgets & Billing(W193) 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. Bonus topic: MAGI Clinical Research Terminology (CRT) codes and hidden costs. Workshop is also illuminating for research sponsors. Bring your laptop for a budgeting exercise. (Related sessions: A202, B161, B222, B247, B390, E322)
Special Topics(W194) You Want What? Practical Negotiation Techniques
Effective negotiation is part of any constructive relationship. Expert negotiators are more likely to get what they want AND form stronger partnerships. Workshop will include hands-on exercises. Learn skills you can use in all aspects of your life. (Related sessions: E219, E256, W204)
Special Topics(W204) Building & Sustaining High-Performance Teams
Leaders, colleagues and sponsors: High performance teamwork drives higher-quality outcomes. (Related sessions: E219, E256, W194)
Contracts(W236) Into the Abyss: Subject Injury and Indemnification
A deep dive into the subject injury and indemnification sections of clinical trial agreements. (Related sessions: A104, A108, A202, A339, B390)
Special Topics(W239) Implementing a Quality Management System for Sponsors, Sites and CROs
In this interactive workshop, we will explore interwoven processes and tools used in a Quality Management System, such as process mapping, gap analysis, quality metrics, risk management, CAPA, and procedural documents and tools. (Related sessions: C138, D450, E120, E312)

12:45pm - 02:00pm(X988) Clinical Research Contract Professional (CRCP) Certification Exam (2)
MAGI offers certification for clinical research contract professionals. Certification is available only at MAGI’s Clinical Trial Agreements and Budgets conferences. Attending the conference is excellent preparation for the certification exam. The exam is optional and open to everyone. Also offered on Tuesday. There is an additional $369 fee to take the exam. More information.

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