Agenda

The focus areas for the 2020 Fall Onsemble conference include:

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

*Times are displayed in Eastern Time (ET)

Monday, October 5, 2020

10:00 am ET

Speaker:

  • Bishoy Anastasi
    Director of Clinical Research Finance, UCLA Dean’s Office

Coverage Analysis Workshop™

Monday 10:00 am - 6:00 pm ET

This one-day, interactive clinical research finance workshop offers up to 9 hours of continuing education credit through SOCRA & ACRP. The training includes practical, step-by-step tutorials related to clinical research budgeting and billing compliance, and provides attendees an opportunity to earn Coverage Analysis Certification™.  Key training topics will include:

  • Clinical research billing regulations and Coverage Analysis best practices
  • Key considerations for OnCore financials implementation
  • Study activation workflow engineering and research budgeting and billing compliance
  • Research charge master considerations and functionality
  • Strategies to maximize utility of OnCore billing grids for OnCore and EHR interfaces

This session is designed and 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 finance, coverage analysis, and research billing compliance. Bishoy has 20+ years of clinical research management experience, and co-authored and oversees coverage analysis and research pricing policies and processes for a leading academic medical center. 100% of previously surveyed attendees recommend this training to others.

This workshop has a separate fee of $995, which includes the one-day training, training materials, and the post training assessment and remote practicum for Coverage Analysis Certification™.

Tuesday, October 6, 2020

1:30 pm ET

Speakers:

  • Kira Hulse, BSc, CCRP
    CTMS Analyst, Clinical Trials Office, Research Quality and Education Moffitt Cancer Center
  • Kim Smith, MS, RN, CCRP
    Research Clinical Specialist, Clinical Trials Office, Research Quality and Education Moffitt Cancer Center
  • Mollie Bodin, M.A.
    Business Intelligence Analyst Senior, Clinical Trials Support Office, University of Michigan Medical School Office of Research
  • Cyndi Bower, M.S.
    Director, Clinical Trials Support Office, University of Michigan Medical School Office of Research

Institutional Perspectives on Stabilizing Clinical Research & Managing Communication during COVID-19

Tuesday 1:30 pm - 2:20 pm ET

Kira Hulse and Kim Smith of Moffitt Cancer Center, along with Cyndi Bower and Mollie Bodin of the University of Michigan Medical School Office of Research will present on measures they implemented throughout the COVID-19 pandemic. The University of Michigan ensured uninterrupted support to human research studies, and the Moffitt team utilized OnCore to manage subjects, protocol statuses and provide guidance for study deviations and subject status changes. Both institutions worked to stabilize their research teams through collaboration, ensuring effective communication and training, and continuous improvement at the department and institutional levels.

ACRP, CBRN & SOCRA CE Credit Available

2:45 pm ET

Speakers:

You’re in OnCore, Now What? Leveraging Your Integrations for Accountability

Tuesday 2:45 pm - 3:35 pm ET

Amanda Childs from University of Colorado, Anschutz and Marissa Macri UCHealth will present their philosophy for keeping study teams accountable while using the OnCore system. After jointly implementing interfaces with Epic, they gathered lessons learned on collaborative processes, reports, training tools for auditing, and evaluating end-user use. Childs and Macri will also share how each institution is leveraging Insights for end-user buy-in to the OnCore system.

ACRP, CBRN & SOCRA CE Credit Available

3:45 pm ET

Welcome Networking: Trivia Event

Tuesday 3:45 pm - 4:40 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.

Wednesday, October 7, 2020

11:00 am ET

Speaker:

Guest Keynote: Thriving in the Midst of Adversity

Wednesday 11:00 am - 11:50 am ET

Devon Still is a former professional athlete, author, top resiliency expert, motivational speaker, and advocate for childhood cancer awareness. Still will speak about his daughter’s experience beating cancer and how he has overcome challenges in his own life to find success and share his message of hope and inspiration with others.

12:15 pm ET

Speaker:

  • Brett Weaver
    CTMS Trainer and Customer Experience Analyst, University of Minnesota

Managing Multi-Site Studies

Wednesday 12:15 pm - 1:05 pm ET

Join Brett Weaver of the University of Minnesota as he provides an overview of multi-site study capabilities and tracking within OnCore, including setup, maintenance, and follow-up. He will outline the process used by UMN as a coordinating center, showing how to add and track separate institutions, track IRB, upload and maintain documents and more, all while limiting PHI to all external institutions/sites. Weaver will also provide a demonstration of eCRF tracking for study subjects and review how UMN switched to the Forte EDC platform to establish 21 CFR Part 11 compliance for PI sign-off.

ACRP, CBRN & SOCRA CE Credit Available

1:30 pm ET

Speakers:

The Keys to Successful Transition to Remote Work: Process, Procedures, and People

Wednesday 1:30 pm - 2:20 pm ET

In this session, Julie Anthony, Kerri Briesmiester, and Lyle Portice of the University of Michigan Clinical Trials Management System Team implemented a complete transition to a fully remote support team at the onset of the COVID-19 pandemic. They will discuss how they were successfully able to do so, ensuring the system and data remain sound while operating remotely. Implementing tools and processes to support the new remote work requirement has been imperative to their success of keeping research moving forward.

ACRP, CBRN & SOCRA CE Credit Available

2:45 pm ET

Speakers:

  • Sami Naber, MBA, CRA
    Senior Post Award Analyst, Post Award Reporting and Compliance, Cedars-Sinai Medical Center
  • Tricia Pearce, J.D.
    Associate Director, Clinical Trials Administration Office, Cedars-Sinai Medical Center
  • Suzanne Calzada
    Senior Contract Officer, Clinical Trials Administration Office, Cedars-Sinai Medical Center
  • Jill McKinley
    Staff Aug, Advarra

Rolling Out Financials and CRPC

Wednesday 2:45 pm - 3:35 pm ET

Have you wondered how to change the financials process of an organization towards a centralized budgeting and invoicing team? Jill McKinley of Advarra, along with Suzanne Calzada, Tricia Pearce, and Sami Naber of Cedars-Sinai Medical Center will discuss the steps CSMC took to move general research budgets and invoicing into OnCore and to start the process of centralizing financial activities. They will discuss leadership decisions, charge master changes, process documentation, training, adoption, and the budgeting building process. They will point out how the billing grid integration helps to promote accuracy in patient billing and the payments integration documenting invoices and payments, as well as how the process is working today.

ACRP, CBRN & SOCRA CE Credit Available

Thursday, October 8, 2020

11:00 am ET

Advarra General Session: Strategies and Moving Research Forward

Thursday 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

Speaker:

Managing Research Operations During COVID

Thursday 12:15 pm - 1:05 pm ET

Join us to hear executive leadership from an academic medical center talks about how the COVID-19 global pandemic has impacted research, operations, and workflows this year.  Discussion on how research can continue to move forward as well as learned lessons for continuity will be discussed.

ACRP, CBRN & SOCRA CE Credit Available

1:30 pm ET

Speaker:

Beyond Remote Monitoring - Conducting a Clinical Trials Audit Remotely During a Pandemic

Thursday 1:30 pm - 2:20 pm ET

ACRP, CBRN & SOCRA CE Credit Available

2:45 pm ET

Speakers:

Implementing OnCore & eReg Simultaneously

Thursday 2:45 pm - 3:35 pm ET

Join Stacey Banks, Erwin Go, and Saheed Shittu of Inova Health System as they discuss the decision-making and processes behind their simultaneous OnCore and Forte eReg implementations. Banks, Go, and Shittu will also discuss how Inova organized the process, their decision on implementing Forte eReg before OnCore, and how it all came together.

ACRP, CBRN & SOCRA CE Credit Available

3:45 pm ET

Talk to the Experts

Thursday 3:45 pm - 4:40 pm ET

Friday, October 9, 2020

11:00 am ET

Speakers:

  • Ilsa Gaulke
    ICTR OnCore Training and Support Specialist, University of Wisconsin – Madison Institute for Clinical and Translational Research (ICTR)
  • Sheri Alexander
    ICTR OnCore Administrator, University of Wisconsin – Madison Institute for Clinical and Translational Research (ICTR)

From In-Person to Online Training: One Site's Experiences Converting

Friday 11:00 am - 11:50 am ET

In this session, Sheri Alexander and Ilsa Gaulk of the University of Wisconsin-Madison will explain how their team created user-friendly online courses using a mix of Forte Academy offerings and site-specific materials. Alexander and Gaulk will discuss the training structure used, the requirements for staff to gain role-based access to the OnCore environment, and preview future enhancements they are planning to implement.

ACRP, CBRN & SOCRA CE Credit Available

12:15 pm ET

Speaker:

Managing Research Compliance in the “New Normal” (IBC, IRB regulations, SOPs, staffing)

Friday 12:15 pm - 1:05 pm ET

The FDA recently updated its guidance regarding flexibility during the COVID-19 pandemic, and other regulatory agencies are also issuing new guidance. In this session, James Riddle of Advarra will explore the flexibility the FDA and other agencies are offering, covering everything from documenting consent to utilization of telemedicine and remote endpoint verification. He will also discuss other topics of interest such as remote monitoring and virtual/remote data collection. Riddle will also share best practices on how research organizations should document their decisions and changes made during the pandemic.

ACRP, CBRN, SOCRA & CIP CE Credit Available