Agenda

The focus areas for the 2021 Fall Onsemble conference include:

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

*Times are displayed in Eastern Time (ET)

Monday, October 4, 2021

10:00 am ET

Speaker:

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

Coverage Analysis Certification™

Monday 10:00 am - 6:00 pm ET

This interactive, virtual, one-day workshop offers up to 10 hours of continuing education credit through SOCRA & ACRP, and provides an opportunity to achieve Coverage Analysis Certification™. The training includes practical, step-by-step tutorials focused on clinical research coverage, budgeting and billing best practices. Key training topics will include: •Clinical research billing regulations and Coverage Analysis best practices •Strategies to maximize the utility of OnCore billing grids, including OnCore and EHR interfaces •Best practice approaches to OnCore financials implementation & user adoption •Study activation workflow engineering and research budgeting and billing compliance •Research charge master considerations and functionality Attendees will receive a participant guide, practical 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. Session Trainer: The training is led by Bishoy Anastasi, a national subject matter expert in clinical research finance, coverage analysis, and research billing compliance. Bishoy brings 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. •Bishoy has trained 350+ research faculty and staff across 50+ sites and sponsors. •100% of surveyed attendees would recommend this training to colleagues. •97% of surveyed attendees rate the training amongst the best trainings they’ve attended. Who Should Attend? This session is designed for coverage analysis, budget development, research finance, and/or clinical research billing compliance stakeholders. Additional Info: This workshop has a separate fee of $995, which includes the one-day training, training materials and job aids, as well as a post-training assessment and practicum to earn Coverage Analysis Certification™. Please note, a key enhancement for this session will now include dedicated training time to complete the Certification assessment and practicum (previously, remote practicums were required to be submitted post-training).

Tuesday, October 5, 2021

11:00 am ET

Speakers:

General Session: Welcome & CEO Keynote

Tuesday 11:00 am - 11:50 am ET

11:55 am ET

Speakers:

  • Brian Sevier, PhD
    COO, Clinical & Translational Science Institute, University of Florida
  • Tiffany Danielle Pineda
    Research Navigator and Chair, DC3 (Diversity and Cultural Competence Council), UF Clinical and Translational Science Institute

Bright IDEA: Improving Inclusion, Diversity, Equity and Access in Clinical Research

Tuesday 11:55 am - 12:50 pm ET

In this session, Brian Sevier and Tiffany Danielle Pineda from the University of Florida CTSI will present practical ways to address Inclusion, Diversity, Equity and Access (IDEA) through translational workforce development and research participant recruitment. They will outline the university's resources for the translational workforce to promote competency in the areas of IDEA, and to deploy tools and resources to break down barriers to reach under-represented minority populations and provide them a voice in health-related human subjects research. This presentation will highlight the university's successes and share practical, actionable ways to celebrate, educate, and enhance IDEA in their local research enterprise.

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

Speakers:

  • Tim Van Dijk
    Business Systems Analyst, University of Michigan
  • Kristen Matta
    Lead Business Systems Analyst, University of Michigan

Operationalizing Knowledge to Optimize Calendaring Workflows

Tuesday 11:55 am - 12:50 pm ET

In this session, Kristen Matta and Tim Van Dijk, analysts from the University of Michigan’s Calendar Review & Analysis Office (CRAO), will discuss their experiences optimizing OnCore calendaring workflows. With the OnCore calendar playing a central role for so many end-users, increasing calendar quality was identified as a high-priority goal with wide-ranging benefits. Kristen and Tim will highlight the collaborative practices that helped to jump-start the development of process efficiencies, share creative solutions that were identified in the process, and review challenges encountered along the way.

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

1:25 pm ET

Speakers:

Panel Discussion: Improving Site Feasibility & Selection through Collaboration

Tuesday 1:25 pm - 2:20 pm ET

For both sites, sponsors and CROs, site feasibility and selection can feel outdated, redundant, and inaccurate. In this session, representatives from across the industry will investigate current processes, discuss new approaches, and present blueprints for a better way to leverage existing data and solutions, advocate for inclusive practices, and more.

In this session you will learn:

  • What sponsors really look for in sites when it comes to feasibility and selection
  • New approaches to leveraging data and technology to eliminate redundancy
  • What opportunities still remain to improve this process

ACRP, CBRN & SOCRA CE Credits Available Hot Topics

Speaker:

An Introduction to Advarra eConsent

Tuesday 1:25 pm - 2:20 pm ET

Advarra eConsent is a mobile-friendly electronic consenting system that keeps participants engaged, enhances their understanding, simplifies compliance oversight, and optimizes the overall quality of the consenting process. During this session, Kate Yawman, Director of Product Management at Advarra, will introduce Advarra eConsent as well as discuss how it supports research site workflows and improves the experience for study participants. Kate will also share a few exciting enhancements on the roadmap and field questions from attendees.

ACRP CE Credits Available Regulatory

Speaker:

Advarra University: Training as Good as Gold!

Tuesday 1:25 pm - 2:20 pm ET

In this session, Advarra's Technical Training Team will show you how to mine Advarra University for learning opportunities for your organization. You'll also learn how you can to use both out of the box and custom solutions to further invest in your learners at your organization. This session will be invaluable for any organizations looking to improve the value and quality of training at their organization.

ACRP CE Credits Available Training / Adoption / Implementation

2:25 pm ET

Speakers:

Leveraging the Advarra–Huron Formal Partnership at Your Organization

Tuesday 2:25 pm - 3:20 pm ET

This session will provide an overview of what the Advarra-Huron partnership means for you. We will share ideas on how to best utilize Advarra’s technical best practices with Huron’s larger research operations expertise to optimize your research organization and foster a greater Advarra product adoption.

ACRP CE Credits Available Training / Adoption / Implementation

Speaker:

  • Jake Meyer
    Senior Manager, Business Operations Services, Advarra

This Year’s Most Common Pitfalls in Coverage Analysis

Tuesday 2:25 pm - 3:20 pm ET

Maintaining billing compliance is a challenge within clinical trials. In this session, Jake Meyer will review common site practices that conflict with Medicare’s policies and best practices. These topics include hepatitis and HIV screening in oncology, maintaining consistency across your patient population, the use of Medicare’s ‘Seven Desirable Characteristics of a Clinical Trial’ decision memo, and accounting for the many new national and local coverage determinations.

ACRP, CBRN & SOCRA CE Credits Available Financials

Speakers:

Panel Discussion: Creative Approaches to Accelerate Study Startup

Tuesday 2:25 pm - 3:20 pm ET

Efficient study startup remains a burdensome and costly challenge for stakeholders across the industry. Join our panel of sites, sponsors and CROs as they discuss current realities, lessons learned, and quick wins in the study startup research step.

In this session you will:

  • Hear unique strategies improving the state of study start up between sites, sponsors and CROs
  • Explore partnership opportunities to implement at your organization
  • Discuss what else can be done to improve both study startup and industry collaboration

ACRP, CBRN & SOCRA CE Credits Available Hot Topics

3:25 pm ET

Speaker:

How Sites and Sponsors Can Work Together to Improve Site Experience

Tuesday 3:25 pm - 4:20 pm ET

In the constant efforts to accelerate drug development and bring treatments to market faster, collaboration between sites and sponsors is vital. In this session, Aidan Gannon of Advarra will provide strategies for sites and sponsors to ensure a positive site experience for industry trials. He'll discuss the importance of streamlined process, open communication, and a site-centric approach to technology to keep research moving forward.

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

Speakers:

  • Casey O'Hara
    Application System Technical Analyst – Consultant, Intermountain Healthcare
  • Anuja Gutal
    Research Information Systems Administrator, Intermountain Healthcare

Implementing CRPC Billing Grid Integration with Clinical Conductor

Tuesday 3:25 pm - 4:20 pm ET

Intermountain Healthcare recently implemented a Clinical Research Process Content (CRPC) billing grid integration between Clinical Conductor and their Cerner EMR. The integration allows them to centralize their billing workflows and improve billing compliance across their research portfolio. In this session, Anuja Gutal and Casey O'Hara from Intermountain will outline their implementation process and share lessons learned after launching the integration.

ACRP, CBRN & SOCRA CE Credits Available Financials

Speaker:

It's an Art, Not a Science: EDC Form Design Principles

Tuesday 3:25 pm - 4:20 pm ET

Designing forms to capture all the information your users need can be difficult. Making the form easy to understand can be even trickier! In this session, Advarra's Sr. Training Advisor Stephen Shapiro will discuss some of the best practices for designing forms in our EDC software. Stephen will discuss some common use cases for forms, as well as highlight additional resources for building forms efficiently.

ACRP CE Credits Available Regulatory

4:30 pm ET

Networking Event: Virtual Trivia!

Tuesday 4:30 pm - 5:30 pm ET

Sponsored by: Huron

Clean and press your favorite pair of smarty pants and prepare to compete in this fast-paced virtual general knowledge trivia game!

This is a 60-minute four-round competition that pits peers against each other in individual cut-throat competition! Show off your knowledge and brainpower through a series of fast-paced trivia questions, designed for a fun & intellectual experience. 

Please note: attendees should join Zoom link from their computers/tablets but need to have a phone available to submit trivia answers.  

Wednesday, October 6, 2021

10:55 am ET

Speakers:

General Session: Product & Service Deep Dive

Wednesday 10:55 am - 11:50 am ET

11:55 am ET

Speaker:

  • Nick Fisher, MBA
    Executive Director of Research & Business Administration, Siteman Cancer CenterWashington University & Barnes Jewish Hospital

Tracking and Reporting Minority Clinical Trial Accruals

Wednesday 11:55 am - 12:50 pm ET

Presentations frequently address center-specific outreach strategies and various approaches to increase minority participation in clinical trials. Much less common are discussions of how best to track, calculate, report, and share minority clinical trial accrual rates within our centers. OnCore can be a valuable tool in such work. In this session, Nick Fisher of Siteman Cancer Center will discuss several different metrics that can be used to perform extensive analysis of minority clinical trial accrual and how OnCore can support such efforts. He will also explore how integrations with other data sources, including EMRs, can further advance these efforts. Finally, he will consider optimal ways to report data to key personnel within our centers as well as policies and procedures related to enforcement and accountability.

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

Speakers:

Models to Scale Training During and After the Pandemic

Wednesday 11:55 am - 12:50 pm ET

In this session, Marcus Miers and Erick Sperloen of Advarra will cover strategies for delivering training during and after the pandemic. They will outline the differences between the most common training delivery methods, why and how you should use them, and how you can develop content as efficiently as possible. Attendees will gain insight on how to use these best practices to suit your training needs now, and get new ideas for your training in the future.

ACRP CE Credits Available Training / Adoption / Implementation

1:25 pm ET

Speaker:

Electronic Systems in Clinical Research - How to Implement Validation in the New Virtual World

Wednesday 1:25 pm - 2:20 pm ET

Electronic systems in clinical research provide data integrity and quality while offering real time monitoring capabilities. Understanding how to implement electronic systems, establish policies and procedures around eReg, eSource and eConsent are vital to the clinical research site and the integrity of the data. This session will discuss how to establish computerized systems across your clinical research portfolio. Candi Barlow of Advarra will identify types of records used in electronic format that are used to create, modify, maintain, archive, retrieve and transmit clinical research data and how to remain compliant in the new virtual world incorporating guidance documents. She will also outline training programs and validation methods to support the implementation of our computerized systems to conduct clinical research.

ACRP, CBRN, SOCRA & CIP CE Credits Available Regulatory

Speaker:

Embrace the Rainbow: Why Your Training Program Must be Unique

Wednesday 1:25 pm - 2:20 pm ET

In our user community, everyone is united in the goal of sharing best practices and not "reinventing the wheel." But when it comes to end user training, each organization should build an end user training strategy unlike any other. While we can learn and share best practices within the community, answering deceptively simple questions such as "who needs to be trained?" and "what do they need to learn?" can lead to very different answers at each organization. In this session, Stephen Shapiro of Advarra will provide key questions to ask as you design an end user training program based on the scope, size, speed, and staffing of your software implementation project.

ACRP CE Credits Available Training / Adoption / Implementation

2:25 pm ET

Speaker:

21 CFR Part 11 Perspectives in SaMD and Software Systems

Wednesday 2:25 pm - 3:20 pm ET

The 21 CFR Part 11 "Electronic Records and Electronic Signature” regulation has come a long way since its inception in 1997. There has been recent surge in development and deployment of software as a stand-alone medical device popularly termed as Software as Medical Device (SaMD), i.e., software is claimed as the device itself without any hardware. These software devices are lumped under the popular term “digital health” that uses complex algorithm, artificial intelligence, and machine learning. Traditionally, software is connected to a hardware to make it a medical device. Further, there are electronic systems such as electronic data capture (EDC) or computerized systems that may store GxP records, but these are not medical devices. Part 11 applies to aforementioned software and systems, but how do we make a clear-cut distinction whether a software/ system is a medical device or not? Bhanu Sharma, Regulatory Compliance Leader at Stanford University, will take you through the journey of how regulatory agencies such as US FDA and International Medical Device Regulator Forum (IMDRF) classify and interpret software development life cycle and requirements that must be fulfilled for approval and introduction of SaMD to marketplace for screening and/or diagnostic purposes.

ACRP & CIP CE Credits Available Regulatory

Speaker:

  • Lauren Rogers
    Director of Clinical Research, Prism Health North Texas

Improving Financial Management and Reporting Using a Clinical Trial Management Software

Wednesday 2:25 pm - 3:30 pm ET

Since implementing the Clinical Conductor CTMS, Prism Health North Texas has improved financial management and reporting across their portfolio. In this session, Lauren Rogers, Director of Clinical Research, will discuss lessons learned in building budgets, tracking completed study visits, creating monthly reports, and tracking payments with the CTMS.

ACRP, CBRN & SOCRA CE Credits Available Financials

Speakers:

Our Experience in Re-modeling our Approach to the Financial Builds in OnCore

Wednesday 2:25 pm - 3:20 pm ET

We will share our experience in rebuilding and optimizing the OnCore financials management at our site. We will discuss the evolution of our OnCore calendar builds and how we transitioned the process from our Informatics Team to our Pre-Award Team and recently to the Advarra BOS Team. We will share how we engaged Advarra for Financials Training to determine the best approach to restructuring and utilizing our OnCore Charge Master and building our final budgets in OnCore. This training, combined with our BOS calendar builds, has positioned us to more efficiently invoice out of the system and better manage our research billing compliance. We have also recently implemented Vendor Payables and will share our experiences with this new feature!

ACRP, CBRN & SOCRA CE Credits Available Financials

3:30 pm ET

Ask the Experts Happy Hour (Click here to see all links)

Wednesday 3:30 pm - 4:30 pm ET

Thursday, October 7, 2021

10:55 am ET

Speaker:

General Session: Guest Keynote

Thursday 10:55 am - 11:50 am ET

11:55 am ET

Speaker:

Hidden Gems Within the OnCore Enterprise Research System

Thursday 11:55 am - 12:50 pm ET

Did you know that coordinators can click a link in an OnCore Subject and be taken directly to the EDC for that study? In this session, Jill McKinley of Advarra will guide you through the areas of OnCore that might not be well-known in the community. Join us for an engaging peak into useful, little-known, and new features to help you make the most of OnCore CTMS.

ACRP CE Credits Available Training/ Adoption/ Implementation

Speaker:

Hidden Gems Within the Clinical Conductor CTMS

Thursday 11:55 am - 12:50 pm ET

I didn't know that! Join Advarra's Crystal Mendenhall for an engaging peak into useful and little-known features to help you make the most of Clinical Conductor CTMS. Crystal will highlight system capabilities to improve key workflows in study build, configurable pieces of the system, and more, including ways to streamline CTMS processes to make your staff more efficient.

ACRP CE Credits Available Training/ Adoption/ Implementation

Speaker:

Clinical Research Unit Scorecards: Metrics that Drive Performance

Thursday 11:55 am - 1:00 pm ET

Duke successfully implemented OnCore® in May 2018, creating a standardized clinical research experience to manage research from protocol creation to project closeout. In this session, Denise Snyder will outline Duke's efforts to improve portfolio management and optimize data collection by measuring data entry efforts as part of their Clinical Research Unit (CRU) Scorecard. The CRU Scorecard was started several years ago to address areas that needed improvement across the research enterprise. Key areas include enrollment, CRU protocol review times, research practice manager review of OnCore use (subject visit tracking, summary accrual, minimum footprint), and financial practice manager review of OnCore financials (industry budgets, review and signoff, invoicing). Snyder will share how Duke used the scorecard to drive improvements across units in enrollment, operational adoption, and financial attention.

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

1:25 pm ET

Speaker:

Leveraging GCP and Billing Compliance Efforts to Decrease Non-Compliance

Thursday 1:25 pm - 2:20 pm ET

In many organizations, GCP practices remain on the clinical/regulatory side, while billing compliance remains on the finance side. When these teams collaborate, the organization can make the most of their internal resources decrease their clinical research operational risk and non-compliance. In this session, Dawn Pittinger of Moffitt Cancer Center will share strategies and experiences using this collaborative process to improve compliance across an organization.

ACRP, CBRN & SOCRA CE Credits Available Financials

Speakers:

Managing Remote Monitoring

Thursday 1:25 pm - 2:20 pm ET

Over the past year and a half, sites have all been forced to adapt to remote workflows where possible. One area accelerated was the need either establish or extend a process around how your institution can enable remote monitoring for active trials. These remote monitoring visits included access to site technology including eReg, CTMS, EHR and others. During this session, Stuart Cotter of Advarra will talk about how remote monitoring was conducted before and during the pandemic, along with what is now the established norm for monitoring trials moving forward.

ACRP, CBRN, SOCRA & CIP CE Credits Available Regulatory

Speakers:

  • Lauren Talley
    Manager, Clinical Research Informatics, St. Jude Children’s Research Hospital
  • Miranda Kolb, PhD
    Manager, Technology Training, Advarra

OnCore Training Transformation in the Face of a Pandemic

Thursday 1:25 pm - 2:20 pm ET

Creating Custom eLearning for End User Training

A trainer's time is a finite resource and a hot commodity, especially during implementation. There is also a continued need for end user training as people join the organization or switch roles. eLearning can be a great tool to help with this endeavor, but the development process is also a big time commitment. St. Jude partnered with the Advarra Training Team to create custom subject management eLearning based off Advarra's existing curriculum. Over 2.5 months we were able to create a series of eight modules that incorporate Advarra's best practices as well as St. Jude's workflows, policies, and procedures. In this session, training experts from St. Jude and Advarra will discuss best practices and lessons learned for creating custom eLearning solution.

 

ACRP CE Credits Available Training/ Adoption/ Implementation

2:25 pm ET

Speakers:

Demystifying Change Control for Validated Systems

Thursday 2:25 pm - 3:20 pm ET

Validation and change control can be intimidating, especially if you're managing a 21 CFR Part 11 validated system for the first time. Join us in demystifying the change control process as Yasmeen Hafeez shares a detailed case study of Henry Ford Health System's change control and upgrade processes for Advarra EDC, along with a look at how HFHS is managing their system upgrades.

ACRP CE Credits Available Regulatory

Speaker:

Key Performance Indicators: Are You Marketing the Study or Your Site?

Thursday 2:25 pm - 3:20 pm ET

Key performance indicators (KPI) provide sites evidence-based metrics to promote the health of their research sites. Monitoring KPIs offers an in-depth risk-based assessment to analyze and identify areas of practice to strengthen clinical research trial operations. As time is of the essence when deploying clinical trials, a site's ability to be agile with data metrics offers sponsors and CRO quick implementation timelines based on a site's past performances validated by KPIs. This presentation will discuss how to categorize, track, measure, and implement quality indicators within your business and clinical operation to monitor and track your KPIs to monitor your clinical research site's health.

ACRP, CBRN & SOCRA CE Credits Available Hot Topics in Clinical Research

Speakers:

  • Sami Naber
    Program Manager, Clinical Trial Billing, Cedars-Sinai Medical Center
  • Omid Zia
    Grant and Contract Officer, Cedars-Sinai Medical Center

Integration of Financial Systems with OnCore: Lessons Learned About Maximizing Efficiency

Thursday 2:25 pm - 3:20 pm ET

Late in 2019, Cedars-Sinai Medical Center began the process of integrating their financial system with OnCore to maximize transparency and centralize clinical trial billing within the Office of Research Administration. Once completed, new budget and billing practices went into place in the middle of 2020. This presentation, led by Omid Zia and Sami Naber of CSMC, will discuss what they've learned on multiple levels, including items they became aware of during the technical process, how budget creation and builds have evolved, their new billing process, and the rollout to study teams across the institution. They will share where they are now and outline their next steps going forward.

ACRP, CBRN & SOCRA CE Credits Available Financials

3:25 pm ET

Speakers:

Leveraging Advarra Technology to Support CCSG Reporting

Thursday 3:25 pm - 4:20 pm ET

For NCI-designated cancer centers, renewing the Cancer Center Support Grant (CCSG) is a complex, time-consuming process. In this session, members of Advarra's product management team will discuss plans for supporting these complex reporting requirements using Advarra's OnCore CTMS and the Advarra Research Evaluation System (EVAL).

ACRP CE Credits Available Executive/ CTO Leadership

Speakers:

  • Leah Henley
    Clinical Systems Manager, AES: Accelerated Enrollment Solutions
  • Samantha Spell
    Clinical Systems Application and Learning Specialist , AES: Accelerated Enrollment Solutions

Optimize Your Technology to Maximize ROI

Thursday 3:25 pm - 4:20 pm ET

Learn how Accelerated Enrollment Solutions (AES) is investing in people and process improvement to optimize the use of their Clinical Conductor CTMS. Leah Henley and Samantha Spell of AES will share how in-house tools, resources and process changes can increase knowledge of Clinical Conductor functions and improve data accuracy in your CTMS.

ACRP CE Credits Available Training/ Adoption/ Implementation

Speakers:

SAE Integration between Epic and OnCore

Thursday 3:25 pm - 4:20 pm ET

The serious adverse event (SAE) integration between OnCore and Epic is one of the many new capabilities driven by our collaborative product development process. In this presentation, Kacey Richards of Yale Michael Rauwerdink of Advarra will provide an overview of the new interface, covering both the user process and the back end functionality enabling the integration. Kacey and Michael will also cover what information will and will not interface from Epic into OnCore.

ACRP CE Credits Available Training/ Adoption/ Implementation

Friday, October 8, 2021

10:55 am ET

Speakers:

A Deep Dive into OnCore Calendars

Friday 10:55 am - 1:00 pm ET

OnCore Calendars are the foundation for subject visit tracking, budgeting, and sponsor invoicing. Calendars (based on a protocol’s schedule of events) can be built in a variety of ways – expert calendar builders have spent years mastering the processes for analyzing and translating a protocol SOE into an OnCore calendar. In this double session, Advarra trainers Erick Sperloen and Miranda Kolb will share some tips for building OnCore calendars, reviewing calendars built by Advarra’s BOS team, and addressing common scenarios (e.g., imaging that must remain on a fixed schedule, even if the treatment visits are put on hold or rescheduled)

ACRP CE Credits Available Training/ Adoption/ Implementation

Speakers:

Comprehensive Study Builds in Clinical Conductor CTMS

Friday 10:55 am - 1:00 pm ET

As protocols become more complex, the Clinical Conductor CTMS study build has had to follow suit. Join our expert trainers as they walk you through common complexities that have been introduced recently in your protocols.

ACRP CE Credits Available Training/ Adoption/ Implementation