Agenda

The focus areas for the 2021 Spring Onsemble conference include:

  • Executive / CTO Leadership
  • Financials
  • Hot Topics
  • Regulatory
  • Training / Adoption / Implementation

*Times are displayed in Eastern Time (ET)

Monday, April 19, 2021

11:00 am ET

Speakers:

Panel: Improving Access to Research for Diverse and Underserved Populations

Monday 11:00 am - 11:50 am ET

In this panel discussion, representatives from Yale University, Parexel, and Par8o will provide actionable strategies for improving access to clinical research for diverse, underserved populations. The panelists will provide both site and CRO perspectives on how to address key issues such as lack of access to research sites, challenges developing educational materials to adequately reach potential participants, optimizing trial design to accommodate a diverse population, and more. In addition, the group will discuss a new referral model to offer access to clinical trials for patients of Federally Qualified Health Centers (FQHCs) and other community-based health care providers.

ACRP, CBRN & SOCRA CE Credit Available

12:15 pm ET

Speakers:

  • Catee Mullen
    Director of Research Operations, Duke Office Of Clinical Research
  • Molly Grosse
    Senior Manager, Study Start-Up Delivery – Americas, PRA Health Sciences
  • Molly Brock
    Sr. Director Global Site Partnerships, PRA Health Sciences
  • Denise Snyder, MS, RD, LDN
    Associate Dean for Clinical Research, Duke Office Of Clinical Research

Panel: Best Practices for Building Strategic, Sustainable Partnerships Between Sites and CROs

Monday 12:15 pm - 1:05 pm ET

The past year has shown us that, now more than ever, strong working relationships between clinical research sites and CROs are critical to the success of clinical trials. With representatives from Duke University and PRA Health Sciences, our panelists will share their experience working together to create a framework for building strong communication, understanding the priorities of all stakeholders, and ensuring efficient processes throughout the trial lifecycle.

ACRP, CBRN & SOCRA CE Credit Available

1:25 pm ET

Speakers:

  • Carlee Brueser
    Clinical Research Analyst, Duke Office of Clinical Research (DOCR), Duke University School of Medicine
  • Rhodora Garcia, MMCi
    Team Lead, Application Data, Duke School of Medicine – Office of Academic Solutions and Information Systems (OASIS)
  • Catee Mullen
    Director of Research Operations, Duke Office Of Clinical Research

Building a Successful Foundation for OnCore Reporting Throughout the Research Enterprise

Monday 1:25 pm - 2:20 pm ET

In this session, Catee Mullen, Rhodora Garcia, and Carlee Brueser from the Duke Office Of Clinical Research will outline the people and process they have put into place to help with prioritizing and creating OnCore reports. To meet all user needs without overwhelming their reporting team, they created an intake process and governance group to evaluate reporting requests, assess priority of builds and elicit feedback from our user community. The process resulted in more manageable reporting workflows throughout the institution, centralizing key reporting needs and reducing the amount of one-off reports created. The Duke team will walk attendees through their process and highlight some of the "game changer" reports created at their organization.

ACRP, CBRN & SOCRA CE Credit Available Executive / CTO Leadership

2:45 pm ET

Speaker:

  • Brian J. Sevier, Ph.D.
    COO, Clinical & Translational Science Institute and Director, Office of Clinical Research, University of Florida

Response, Resource Expansion, and Recovery: Lessons Learned and Planning for Next Time

Monday 2:45 pm - 3:35 pm ET

The past year presented a scenario that many academic medical centers and health systems weren't prepared for. In this session, Brian Sevier will highlight the University of Florida's approach to initiating a safe shutdown of research activities, appropriately educating the workforce, and slowly returning to a recovery state for the continuation and resumption of research activities. He will then highlight lessons learned at UF, demonstrating how his team can use their experiences to build improved process that will allow them to more successfully navigate future challenges. Finally, he'll engage the audience to learn how others throughout the Onsemble community navigated their challenges and how their experience has informed future operational strategies.

ACRP, CBRN, SOCRA & CIP CE Credit Available Executive / CTO Leadership

3:45 pm ET

Welcome Networking: Trivia Event

Monday 3:45 pm - 4:45 pm ET

Join the Onsemble Community for a not-your-typical networking event. Be entertained with your favorite tunes, bring your preferred happy hour beverage, and network with our industry professionals across the country for a Through the Decades -themed trivial game hour! Top 3 winners receive choice of gift card.

Tuesday, April 20, 2021

11:00 am ET

Speaker:

Guest Keynote - Transforming Lives: The Art of Person-Centered Care℠

Tuesday 11:00 am - 11:50 am ET

Prepare to be taken on a journey. With her perceptive view inside the patient experience, Allison Massari’s riveting and insightful keynote illuminates the immense value that healthcare professionals have upon a patient who is suffering. This dynamic and poignant program offers real solutions to the struggle of how to keep the patient first despite limited time and other practical constraints. By weaving her remarkable journey with potent life-lessons, Allison highlights the integral nature of patient-centered care and fortifies audience members, reigniting their passion for why they went into healthcare in the first place. She explains, "The power of what you do goes far beyond the technical part of your job. You are healing the places medicine cannot touch. In fact YOU are the medicine." Hailed as “life-changing”, Allison’s keynote offers a sincere and direct approach to navigating adversity, transcending life’s difficulties, and always finding a way to be the healer in the room. This content rich and deeply moving speech also offers applicable tools for managing change, adversity, and the everyday challenges of being human.

12:15 pm ET

Speakers:

Panel: Onsemble Community Experiences with Advarra eReg

Tuesday 12:15 pm - 1:05 pm ET

This panel discussion will feature representatives from Karmanos Cancer Institute, Duke University, and Lifespan. Moderated by Advarra eReg product manager Stuart Cotter, the group will share their experience and outline best practices within the system, including implementation, validation, remote monitoring, and more. Attendees will have the opportunity to submit questions to be included in the discussion.

ACRP, CBRN & SOCRA CE Credit Available Regulatory

1:30 pm ET

Speakers:

  • Jon Tack
    Vice President, Product Management, Advarra
  • Marc Buehler
    Clinical Research Systems Manager, UW Carbone Cancer Center
  • Annie Geo-Thomas
    Business Systems Analyst Senior, University of Michigan
  • Mike Lee, MPH, CCRP
    Business Systems Analyst Senior, University of Michigan

Strategies and Best Practices for Enterprise Technology Upgrades

Tuesday 1:30 pm - 2:20 pm ET

In this session, Marc Buehler of the UW Carbone Cancer Center will join Mike Lee and Annie Geo-Thomas from the University of Michigan to discuss key strategies and best practices for enterprise system upgrades. The group will highlight preparations, testing scripts, timelines, day-of-upgrade steps, and more for OnCore upgrades, as well as lessons learned that can be applied to non-OnCore enterprise system upgrades. They will also share recent improvements to upgrade processes and outline their process for collaborating with end users.

ACRP, CBRN & SOCRA CE Credit Available Training / Adoption / Implementation

2:45 pm ET

Speakers:

Lessons Learned from Connecting Enterprise Technology Across the Research Ecosystem

Tuesday 2:45 pm - 3:35 pm ET

Enterprise integrations are a key driver of efficiency and data quality for many Onsemble Community members. Cedars-Sinai Medical Center has leveraged numerous OnCore integrations, including CRPC billing grid interface, demographics and RPE protocol/subject integrations, the Receivables Interface connecting OnCore to general ledger systems, and more. The team will walk attendees through their integrated ecosystem, sharing their experiences implementing the interfaces and highlighting areas where Cedars-Sinai has realized the most value.

ACRP, CBRN & SOCRA CE Credit Available Training / Adoption / Implementation

Wednesday, April 21, 2021

11:00 am ET

Advarra General Session - Working Together to Make Clinical Research Safer, Smarter, and Faster

Wednesday 11:00 am - 11:50 am ET

In this general session, members of the Advarra leadership team will highlight accomplishments within the Onsemble Community, provide updates on Advarra products and services, and share our vision for a connected future.

12:15 pm ET

Speakers:

Regulatory and Ethical Considerations for Review of eConsent in Research

Wednesday 12:15 pm - 1:05 pm ET

In this session, members of the Advarra IRB Regulatory team will discuss the use of electronic informed consent (eConsent) in the context of human subjects research. We will discuss what human research protection regulations require when eConsent is used, and how these requirements can be satisfied during an electronic informed consent process. We will also discuss how the Advarra IRB reviews eConsent processes and what factors we consider in our reviews.

ACRP, CBRN, SOCRA & CIP CE Credit Available Regulatory

1:30 pm ET

Speakers:

  • Allie Moses
    Research Systems and Recruitment Center Manager, MedStar Health Research Institute
  • Candice Vance
    Director of Clinical Research Revenue Cycle, MedStar Health Research Institute

Optimizing the Research Revenue Cycle From Protocol Initiation to Completion

Wednesday 1:30 pm - 2:20 pm ET

In this session, Candice Vance and Allison Moses of MedStar Health Research Institute will share their experiences optimizing financial workflows within OnCore, highlighting how OnCore Financials functionality supports MHRI's research revenue cycle from protocol initiation to completion. They will discuss how various key staff roles at MedStar, from managers, budget analysts, study coordinators, billing associates and administrators, use and benefit from the information tracked in the Financials Console throughout the protocol lifecycle.

ACRP, CBRN & SOCRA CE Credit Available Financials

2:45 pm ET

Speakers:

Advarra Managed Infrastructure: Security and Compliance Considerations

Wednesday 2:45 pm - 3:35 pm ET

More than half of OnCore customers rely on hosting and infrastructure provided through Advarra Managed Infrastructure. Led by Advarra's Security Officer and SVP of Technology Beau Grignon, this session will explore the benefits of Advarra Managed Infrastructure, focusing on topics related to compliance, security, and efficiency. Beau will be joined by representatives from Baptist Health South Florida, who will share their experiences moving to the managed solution.

ACRP, CBRN & SOCRA CE Credit Available Hot topics

3:45 pm ET

Talk to the Experts

Wednesday 3:45 pm - 4:45 pm ET

Join Advarra experts to learn more our products and services, get your questions answered, and see Advarra technology in action. Representatives from Advarra’s product management, customer relationships, consulting, IRB/IBC, systems administration, and leadership teams will be on hand to connect with you. Note: we will facilitate these sessions using the RingCentral video app. If you need to download the app, visit https://support.ringcentral.com/download.html or consult your IT team.

Thursday, April 22, 2021

11:00 am ET

Speaker:

Mobile Medical Applications, New Technology and IRB Review

Thursday 11:00 am - 11:50 am ET

When does a mobile application meet the definition of a medical device under the Food Drug, and Cosmetic(FD&C) Act, and how does FDA intend to apply its regulatory authorities to mobile medical apps? In this session, Advarra's James Riddle will answer common questions pertaining to mobile apps, helping to distinguish when mobile apps meet the definition of a medical device, understand FDA’s current approach to applying its regulatory authorities to oversight of mobile medical apps, and more.

ACRP, CBRN, SOCRA & CIP CE Credit Available Regulatory

12:15 pm ET

Speaker:

  • Kristina Harr, J.D.
    Director, Clinical Trial Support, Children’s Hospital of Philadelphia (CHOP)

Developing a Successful Enterprise Expansion Strategy

Thursday 12:15 pm - 1:05 pm ET

The Children’s Hospital of Philadelphia (CHOP) was the first pediatric site to transition from cancer center to enterprise. At a previous Onsemble Conference, the team shared their implementation process, strategies for obtaining buy-in from leadership, their ideal team structure, and more. In this session, Kristina Harr, Director, Clinical Trial Support at CHOP, will provide a brief review of those topics, and share her team's experiences and lessons learned in building an enterprise expansion strategy to ensure success now and into the future.

ACRP, CBRN & SOCRA CE Credit Available Training / Adoption / Implementation

3:00 pm ET

Speaker:

Coverage Analysis Certification™

Thursday 3:00 pm - 7:00 pm ET

By registering for this workshop, you are registering for the entire course which takes place on Thurs and Fri.

This two-day, interactive clinical research finance and coverage analysis training offers up to 12 hours of continuing education credit through SOCRA & ACRP. The training includes practical, step-by-step tutorials related to coverage analysis, budgeting and research billing compliance, and provides attendees an opportunity to earn Coverage Analysis Certification™. Key training topics will include:
-Understanding and applying clinical research billing guidelines and regulations
-Coverage Analysis best practices
-OnCore financials implementation and optimization
-Integrating research budgeting and billing compliance within study activation workflows
-Research charge master considerations and functionality
-Leveraging OnCore billing grids to facilitate research charges through OnCore/EHR interfaces

This session is best suited for coverage analysis, budget development, research finance, and/or clinical research billing compliance stakeholders. Attendees will receive a participant guide, job aids and guidance materials adopted by leading medical centers to support OnCore budget development and coverage analysis best practices. Attendees will also have the opportunity to become Certified Coverage Analysts™ by successfully demonstrating subject matter proficiency through a post-training assessment and remote practicum.

The training is led by Bishoy Anastasi, a nationally recognized subject matter expert, particularly in research operations, coverage analysis, finance and research billing compliance. Bishoy’s career spans 20+ years in clinical research leadership and operational roles. In addition, Bishoy co-authored and oversees coverage analysis and research pricing policies and processes for a leading academic medical center. 100% of surveyed attendees would recommend this training to others, and 97% rate the training amongst the best trainings they have attended.

This workshop includes a pre-training benchmark, two-days of remote training (4 hours each), training materials, post-training assessment and remote practicum (practicum is only required for those pursuing Coverage Analysis Certification™).

Friday, April 23, 2021

12:00 pm ET

Speaker:

Coverage Analysis Certification™

Friday 12:00 pm - 4:00 pm ET