Breakout

Breakout Sessions I

April 29, 2021 • 0 Comment

It’s Not You, It’s Me: How To Manage Long-term Partnerships

*Collaboration & Partnership
As the pipeline of clinical trial work evolves and changes over time, the importance of quality relationships between sites and sponsors/CROs will increase. Sponsors and CROs will engage sites that align with current and mid-term projected opportunities, and remaining in contact over the long-term will become even more important. Attendees will leave this session with insight into navigating clinical trial evolution to position your site for success.

FACILITATOR
Chris Hoyle, MBA, Executive Director, Elite Research Network

PANELISTS
Silvina Baudino, MS, Director, Site Strategy, Teckro
Lindsey Morales, Senior Manager, Site Centric Solutions, Labcorp Drug Development
Robyn Schmidtke, RN, MBA, Senior Site Relationship Manager, Merck

Winning Your Study: A Playbook for Success

*Development & Marketing
Some sites get it right more often than not. So what are these sites doing to win studies? In this session, learn from some of the most successful sites and get a glimpse at their “playbook” for winning more studies.

FACILITATOR
Peter Fredette, Director, Oncology Site Relations Director, IQVIA

PANELISTS
Dan Otap, CCRP, Sr. Alliance & Partnership Leader, Genentech
Nicholas Focil, MBA, MS, CEO, Fomat Medical Research
Laura Falcone, APRN, COO, Meridian Clinical Research

Innovative Methods to Revolutionize Your Business Development Practices

*Development & Marketing
If your business development (BD) efforts involve calling the same people for study leads you were using five years ago, your site is likely missing out on valuable opportunities. Join this discussion to find out how other sites have reinvigorated their business development processes and found new channels for growth.

FACILITATOR
Adrienne Bush, MA, Director, SSU and Regulatory, Site Identification, Syneos Health

PANELISTS
Wes Bonner, VP, Strategic, Development, Meridian Clinical Research
Keith Fern, Vice President, Corporate Development, Elligo Health Research

Hybrid Decentralized Trials: Critical Considerations

*Digitalization, Data & Technology
It is no secret that digital innovations are here to stay, especially in the form of decentralized trials. While there are important considerations to be made from an administrative and process perspective, it is equally critical that we consider how patients will be affected. In this session, we will discuss how decentralized trials affect patient interaction, identify what this hybrid clinical trial model really looks like, and outline the value of this newer approach to clinical trials so that patients needs are addressed.

FACILITATOR
Todd Albin, MBA, CCCRP, CEO, Cedar Health Research

PANELISTS
Deena Bernstein, VP, Customer Success, Datacubed
Nicole Latimer, MBA, MHSA, CEO, Medrio
Scott Connor, Chief Marketing Officer, Signant Health
Karin Gulbrandsen, Sr, Director, US Country Lead, Global Clinical Operations, Janssen

eConsent: Progress & Concerns

*Digitalization, Data & Technology
Consent is a crucial process and eConsent is rapidly becoming more popular. How far along are we with eConsent implementation? What are the bottlenecks encountered so far? Is there a hybrid model that could hasten the pace of implementation? Join this session to receive answers to these questions and more.

FACILITATOR
Karen Maduschke, MA, Sr. Director & General Manager, Patient Consent, IQVIA

PANELISTS
Raymond Nomizu, CEO, Clinical Research, IO
James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra
Terry Piedra, CCRC, Director of Business Development, CenExel RCA

What We Really Want: Site & Patient Input for Vendors with Respect to Technology

*Digitalization, Data & Technology
In this session, sites will share the patients hopes and expectations for technology providers in clinical research. Similar to a focus group, this session will collaboratively collect perspectives from the field to help inform future technology adoption and advancement.

FACILITATOR
Doug Schantz, VP, Clinical Operations, Alexion Pharmaceuticals

PANELIST
Barry Lake, CEO, Devana Solutions®
Amber Holst, Director of Clinical Operations, Great Lakes Clinical Trials
Rick Greenfield, CEO, RealTime-CTMS

Must Have Pass-Through Requests

*Finance
What are the best pass-through requests you have asked for during budget negotiations? What pass-through requests do you wish you’d requested? Join this session to hear examples of how to build out your justification and succeed in receiving them from the negotiation phase to receipt.

FACILITATOR
Julia Spears, CCRC, Research Administrator, Asst. to the Director, The University of Toledo, Gardner-McMaster Parkinson Research Center

PANELISTS
Rochelle Redding, MS, CPM, Associate Director Global Site Budgets and Payments, Merck
Matt Lowery, ACRP-CP, CCRC, Executive Director, CRBD+

I Can Live With This CTA: Ensuring Your Negotiations Meet Your Needs

*Legal, Operations & Administration
Your clinical trial agreement is a fundamental and foundational element to every clinical trial. It is also often one of the primary bottlenecks to study start-up. Join a panel of subject matter experts from site, sponsor, and CRO stakeholders to learn tips and tools for effectively negotiating a fair contract. Best practices will be outlined, processes identified, and solutions provided.

FACILITATOR
Michael Pierre, Director of Systems Management, Meridian Clinical Research

PANELISTS
Chuck DeMars, MS, Corporate Director of Budgeting & Contracting, CenExel
Shelley Douros, Sr. Director, Clinical Financial Management, Clinical Operations, Medidata Solutions

FDA Audits: Yes, That Really Happened!

*Legal, Operations & Administration
FDA audits are an inevitable reality that all sites should be prepared for before they are audited. Hear perspectives from those who have experienced FDA inspections to learn how they prepared for the audit and what measures they have implemented to ensure future inspection-readiness. You will have the opportunity to share your audit experiences and hear from others to help you prepare for, lead, and follow up on an FDA audit.

FACILITATOR
Ana Marquez, MSF, President, Clinical Research Partners

PANELISTS
Shivani Shah, MS, ACRP-CP, Exec. Director of Clinical Operations, DM Clinical Research
David Vulcano, MBA, MSW, VP, Research Compliance & Integrity, HCA Healthcare
Rick Arlow, CEO & Founder, Complion
Lisa Kodis, MSN, RN, Associate Director of Research Nursing, Project Delivery, Illingsworth Research Group, Syneos Health

Protocol Feasibility: Tactics & Tools for Success

*Legal, Operations & Administration
Assessing the feasibility of a protocol for your site is an important task. Failure to assess the right sections of a protocol could cost your site financially and impact future study acceptance. Sites now have report cards, so it is important to set your site up to receive an A+ grade! Join this session to learn how to utilize your historical data and communicate constructively for successful study acquisition.

FACILITATOR
Marie Emms, VP Site & Patient Access, Syneos Health

PANELISTS
Jennifer Doraski, US Site Partnership Manager, Oncology, Sanofi
Edward Czerwinski, MD, PhD, Senior Medical Director, Futuremeds
Steven Geller, MD, FACP, CPI, Medical Director, Centennial Medical Group

Evidence Based Outcomes Related to Survey Data Addressing the Need for Site Improvement in Diversity Enrollment Strategy Governance Framework: How Does It Impact You?

*Diversity
The presenters will review recent data related to the Diversity Site Assessment Tool (DSAT) published by SCRS in conjunction with data from Tufts recent survey, CSDD Investigative Site Diversity Study. Learn how this important outcome data applies to an action-oriented approval by clinical research sites in an effort to increase diverse enrollment.
Diana Foster, PhD, VP, Strategy and Special Projects, SCRS

Recruitment Strategies for Complex Protocols

*Patient Experience
As study protocols become increasingly more complex, the participants required will likely be under the care of medical specialists to manage their medical profile. This session will help attendees develop medical educational tools for recruiting complex patient cohorts and understand how to position clinical trials as a care option to targeted populations, creating a more patient-centric approach to drive optimal enrollment.

FACILITATOR
Lauren Chazal, MBA, VP of Global Strategic Alliances, Headlands Research

PANELISTS
Scott Whitt, MA, General Manager, Triad Clinical Trials
Dave Billiter, MBA, CEO and Co-Founder, Deep Lens, Inc.
Miaesha Campbell, Director of Patient Recruitment & Retention, Medpace

Ivor Clarke, CEO, SubjectWell

Investigator Compensation Models for Optimal Engagement & Performance

*Staffing
The level of investigator engagement and performance can have a significant impact on a study or site’s overall success. This session will help attendees understand how various compensation models can increase investigator engagement and improve their recruitment performance.

FACILITATOR
Michael Koren, MD, FACC, CPI, CEO, Jacksonville Center for Clinical Research

PANELISTS
Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT
William B. Smith, MD, FACC, CPI, CEO, Alliance for Multispecialty Research

How to Succeed at Pre-Site & Site Initiation Visits Every Time

*Study Start Up
How can all industry players create more efficiency and effectiveness in the study start-up selection and onboarding process? Join this session to hear best practices for pre-site visit (PSV) and site initiation visit (SIV) success. Sites will also be able to share their preferences for investigator meetings (IM).

FACILITATOR
Sean Cunningham, MBA, Director, Strategic Account Lead, Janssen

PANELISTS
Lauren White, Director of Business Development, CenExel ACMR
Roman Fishchuk, MD, MSc, CEO, Clinical Trials Unit, Central City Hospital

Breakout Sessions II

April 29, 2021 • 0 Comment

PI Oversight: What Is It, Actually?

*Collaboration & Partnership
Lack of PI oversight is one of the most frequent FDA audit findings. This makes it one of the most important activities for your site to dedicate time to improving. A thorough understanding of ICH, GCP and FDA guidelines is critical! You will leave this session with tips, tricks and techniques to avoid inspection findings by showing PI oversight and demonstrating that your PI is fully involved and well-informed.

FACILITATOR
Steve Satek, Founder & President, Great Lakes Clinical Trials

PANELISTS
Dan Otap, CCRP, Sr. Alliance & Partnership Leader, Genentech
Irene Axelrod, RN, CCRC, Founder, Boston Clinical Trials
Jing Bao, MD, PhD, Co-Founder & Chief Medical Officer, Drug Development and Filing Consulting (DDFL), LLC
Chris O’Shaughnessy, Vice President of Business Development, Curavit

Advanced Social Media Tactics That Work

*Development & Marketing
Most patient recruitment experts agree that social media works. The problem is knowing which social media tactics generate the results you need, when you need them. This session will walk you through advanced social media strategies and tactics to help you consistently meet your enrollment goals.

FACILITATOR
Matt Miller, President & CEO, StudyKik

PANELISTS
Miaesha Campbell, Director of Patient Recruitment & Retention, Medpace
Wes Bonner, VP, Strategic Development, Meridian Clinical

The Competent Investigator Understands Both Compliance and Excellence

*Collaboration/Partnership
This interactive session will focus on the skills needed to make an excellent investigator by comparing compliance and excellence in research. Real life examples will be discussed to understand how an investigator views and responds to compliance regulations in clinical context.

Michael Koren, MD, CEO, Jacksonville Center for Clinical Research

Trust-Building: Utilizing Your Data to Validate Your Site

*Digitalization, Data & Technology
With sponsors and CROs having increased awareness of sites’ potential patient access, gone are the days when studies were awarded based on site information forms or site selection visits alone. This session will help you understand the data sources that sponsors and CROs are using to further validate your site and provide perspective on what kinds of data you should keep and share to position your site for selection.

FACILITATOR
Barry Lake, CEO & Co-Founder, Devana Solutions®

PANELISTS
Kerry Gorman, Director, Strategic Site Solutions, IQVIA
Jeff Stein, President, Stamford Therapeutics Consortium

Exploring the Meaning of Diversity & How it Impacts the Clinical Research Site

*Diversity
The importance of including and enrolling diverse patient populations in clinical research studies continues to gain momentum. In 2017, SCRS took a strong stance on this topic with the creation of the Diversity Awareness Program to evaluate and measure the inclusion of diverse patients globally. Join this session to learn about the SCRS Diversity Program while providing feedback in an interactive focus group. The discussion aims to engage participants with perspective and knowledge on the enrollment of diverse patient populations at your site and in your region or community.

FACILITATOR
Diana Foster, PhD, VP, Strategy and Special Projects, Society for Clinical Research Sites
Fabian Sandoval, MD, President & CEO, Emerson Clinical Research Institute
Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research

Operational Strategies In Uncertain Times

*Finance
We all know that things have been hard over the past year and many sites have struggled to keep the lights on. In this session, hear from experts about what you need to pay closest attention to operationally and financially to keep your good work on track and to mitigate the possibility of shutting down studies and sites.

FACILITATOR
Christin Trujillo, Financial Consultant, Maven Financial Partners

PANELISTS
Scott Palmese, MS, Senior Director Site Networks Mobilization Lead, Accellacare
Steve Clemons, MSN, FNP-BC, NP-C, President & CEO, VitaLink Research
Amy DeWerth, Strategic Account Lead, Janssen Pharmaceuticals

Using Patients Stipends to Establish Fair Market Value

*Finance
Creating an appropriate patient compensation plan is an important aspect of recruitment and retention success. But how do sites know what the industry benchmark is in order to establish a level playing field? During this session, sites and other industry representatives will share their experience and perspective on payment information for specific indications and identify Fair Market Value for patient stipends.

FACILITATOR
Kristine Majors, RN, MS, President/Director of Research, Integrated Clinical Trial Services, Inc.

PANELISTS
Rochelle Redding, MS, CPM, Associate Director Global, Site Budgets and Payment, Merck
Wayne Baker, Chief Commercial Officer, Greenphire

Dissecting a Clinical Trial Agreement

*Legal, Operations & Administration
Clinical trial agreements (CTAs) are lengthy, detailed, and often difficult to understand. How does your site navigate breaking down a typical CTA? Speakers will identify key sections to hone in on and pay attention to, bring attention to oft-negotiated sections, and share resources such as SCRS’ CLEAR guidelines that provide sites with support in the process.

FACILITATOR
Michael Pierre, Sr. Director of Systems Management, Meridian Clinical Research

PANELISTS
Chuck DeMars, MS, Corporate Director of Budgeting & Contracting, CenExcel Clinical Research
Joey Nguyen, MEd, Site Services & Training Manager, ClinEdge

Enrollment & Engagement: How to Acquire & Keep Patients in Trials Using Data-Driven Decisions

*Patient Experience
We live in a world where we need to compete for time and loyalty when it comes to everything from health to ice cream. In this session, learn how to enroll top patients and how to keep them by using behavioral science data to make your decisions.

FACILITATOR
Sarah McKeown-Cannon, Director, Strategic Relationships, Langland, a Publicis Health Company

PANELIST
Kyle Hogan, Chief Strategy & Marketing Officer, Datacubed Health
Lisa Bjornestad, Director, Site Alliance, Parexel, The Americas
Dave Billiter, MBA, CEO & Co-Founder, Deep Lens

Managing Burnout in a Post-Pandemic Age

*Staffing
We have never been through something like this before in our lifetime. And while many of us are doing “just fine”, the grind of balancing work and life during the pandemic has taken a toll. In this session, learn how we can take better care of our patients, our team, and ourselves as we discuss how to manage burnout in a post-pandemic era.

FACILITATOR
Blake Adams, VP, Marketing, Florence Healthcare

PANELISTS
Doug Schantz, VP, Head of Clinical Operations, Alexion Pharmaceuticals
Ryan Clemons, PharmD, RPh, Vice President of Business Development and Science Innovation, BlueCloud® by HealthCarePoint

The Best Staffing Models for Better Quality, Enrollment & Margins

*Staffing
The right staffing model can quickly turn an average site into a high-performing site with efficient operations. But which staffing model is the right fit for your staff and capabilities? This session will identify why most traditional staffing models underperform and share ways to realign job functions to match staffing skills and credentials.

FACILITATOR
Kelly Sanford, MSHS, PMP, CCRA, Head of Decentralized Trials Solutions, Site Operations, IQVIA

PANELISTS
Scott Whitt, MA, President & General Manager, Triad Clinical Trials
Nicole Mills, MS, ACRP-CP, Director, Clinical Research, Medix
Marianne Tadros, CCPM, ACRP-PM, Director of Human Resources, DM Clinical

A Shared Vision: Boosting Your Research Operations

*Legal, Operations & Administration
Establishing a shared vision for clinical research within your organization will support the alignment of your large physician group or hospital system’s research operations. Speakers will provide an administrative overview of the clinical, regulatory, and financial risks of a research business line and discuss how to determine the best research staffing model to drive quality and profitability.

FACILITATOR
Matt Lowery, ACRP-CP, Executive Director, CRBD+

PANELISTS
Michele Cameron, MBA, BSN, RN, CCRC, Dir. Clinical Research, Clearwater Cardiovascular Consultants
Rick Baransky, Senior Director, Site Networks, Accellacare

Study Start-Up: Beyond Regulatory, Budgets & Contracts

*Study Start-Up
When our industry thinks of study start-up, we mainly focus on regulatory documents and fully executed contracts. We often overlook the other components that also need to be in place before screening the initial patient. In this session, sites will share lessons learned and must-do’s before starting a study.

FACILITATOR
James Riddle, MCSE, CIP, CPIA, CRQM, VP, Research Services & Strategic Consulting, Advarra

PANELISTS
Henry Kravchenko, Founder & CEO, Clinical.ly
Roman Fishchuk, MD, MSc, CEO, Central City Clinical Hospital

Breakout Sessions III

April 29, 2021 • 0 Comment

Clinical Trial Pain Points Clinic

*Collaboration & Partnership
Navigating clinical trial pain points can be a difficult process, but it doesn’t have to be. Come participate in an engaging, solution-focused conversation about pain points with respect to vendor management (STS), complex protocols and sponsor/CRO relationships. You will walk away with insight into how experienced site staff have managed these pain points and utilized them to yield positive results.

FACILITATOR
Dan Milam, EMBA, Director, Clinical Trials Partnerships, EQRx

PANELISTS
Lindsey Morales, Sr. Manager, Site Centric, Labcorp Drug Development
Steve Satek, Founder & President, Great Lakes Medical Research
Ellen Street, MBA, Executive Vice President, Product Quality & Management, ERT

Creating & Implementing a Sales & Marketing Budget for Your Site

*Development & Marketing
Attendees will be presented with a challenge of elevating revenue by creating a sales and marketing budget, followed by deciding where to spend the funds. Teams will then present their decisions to other site colleagues. The session will conclude with a Q&A session and practical tips on how to measure the return on investment.

FACILITATOR
Rick Greenfield, BBA-IS, CEO, Lead Inventor, RealTime-CTMS

PANELISTS
Lauren Chazal, MBA, VP, Global Strategic Alliances, Headlands Research
Christin Trujillo, Financial Consultant, Maven Financial Partners

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Remote Working & the Impact on Clinical Research Sites

*Digitalization, Data & Technology
Although sites have never fully stopped being “in the office”, many recent trials have been conducted remotely, and remote work has created added responsibilities for many sites. In this session, we’ll talk about what we can do to prioritize and redistribute added remote activities, including remote monitoring.
FACILITATOR
Lisa Moneymaker, SVP, Clinical Operations Technologies, Medidata Solutions

PANELISTS
William Dirkes, Jr., MD, MBA, President, DocuTrial
Michele Cameron, MBA, BSN, RN, CCRC, Dir. Clinical Research, Clearwater Cardiovascular Consultants
Janet Christoff, RN, Senior Manager Partnerships Liaison, EQRx

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Training & How It Might Occur in the Future

*Hot Topic
With so many changes and an increased amount of new protocols, processes, and technologies entering the industry, it sometimes feels like an insurmountable task to train your newest staff members. But if training became the way we work rather than a prerequisite to work, could the responsibly and outcomes be different? In this session, we’ll talk about how we train our teams today and what could change to make training more effective for all.

PANELISTS

Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT
Al Pacino II, President, BlueCloud® by HealthCarePoint

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Risks, Liabilities, & Pitfalls: What You Need to Know About Contracts & Agreements

Legal, Operations & Administration
Sites already have a large number of tasks to complete, and as soon as the patients leave, you get to do… more paperwork! In this session, learn some tips and tricks from experts on what to pay attention to so your contracts and agreements assist your progress rather than hinder it.

PANELISTS
David Vulcano, MSB, MSW, VP, Research Compliance & Integrity, HCA Heathcare
Ana Marquez, MS, President, Clinical Site Partners

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A Regulatory Look Into Virtual Trials

*Legal, Operations & Administration
Remote patient visits are becoming a typical part of the study experience. How can sites prepare to meet the challenges of the related compliance requirements? Learn to embrace decentralized trial technology and understand how to ensure your site is compliant with regulations.

FACILITATOR
Todd Albin, MBA, CCRP, CEO, Cedar Health Research

PANELIST
Becky Capps, MBA, VP of Product Development, Medrio
Lisa Bjornestad, Director, Site Alliance, Parexel, The Americas
Shivani Shah, MS, ACRP-CP, Executive Director of Clinical Operations, DM Clinical Research

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Level Up Your Recruitment Methods

*Patient Experience
Our work starts and ends with the patient. As a result, nothing is more important than the adoption of innovative recruitment methods. In this session, attendees will share their most successful recruitment tactics, including advertising and social media campaigns, that empowered them to meet milestones and coordinate site- and sponsor-directed efforts to ensure we are delivering highly effective treatments that best support and reach patients faster.

FACILITATOR
Marie Emms, VP Site & Patient Monitoring, Syneos Health

PANELISTS
Jason Roth, VP, Business Development, Platinum Research Network
Joss Warren, Head of Strategy and Partnerships, THREAD Research
Miaesha Campbell, Director, Patient Recruitment & Retention, Medpace

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Interactive Site Selection

*Study Start Up
During this interactive session, attendees will be given the opportunity to complete a typical site questionnaire for an upcoming study. Questionnaires will then be submitted for review to a panel of site selection decision-makers who will select sites to consider for the study. Feedback will then be provided to all attendees as to why the sites were selected and share which attributes of the questionnaire impacted their decision the most.

FACILITATOR
Melynda Geurts, MS, SVP, Business Operations, Total Clinical Trial Management

PANELISTS
Jen Doraski, US Site Partnership, Manager, Oncology, Sanofi
Karri Venn, CAICR, ACRP, President, Research, LMC Manna Research
Steven Geller, MD, FACP, CPI, Medical Director, Director, Centennial Medical Group

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Breakout Sessions IV

April 29, 2021 • 0 Comment

It’s Not You, It’s Me: How To Manage Long-term Partnerships

FACILITATOR
Melynda Geurts, MS, SVA, Business Operations, Total Clinical Trial Management

PANELISTS
Anne-Marie Baughn, RN, MSN, Director, Business Development, Rx Trials
Silvina Baudino, MS, Director, Site Strategy, Teckro
Robyn Schmidtke, RN, MBA, Senior Site Relationship Manager, Merck

Hybrid Decentralized Trials: Critical Considerations

FACILITATOR
Kelly Sanford, MSHS, PMP, CCRA, Head of Decentralized Trial Solutions, Site Operations, IQVIA

PANELISTS
Karin Gulbrandsen, Sr. Director, US Head, Global Clinical Operations, Janssen
Candida Barlow, Senior Account Manager, Clinical Research, Advarra
Mike Minor, ABD, EVP, Clinical Research, IMA Clinical Research

Cardiology: Your Time, Your Questions, Your Stories

*Hot Topic
When it comes to your specialty, you have specific questions that need to be answered and unique experiences that need to shared. In this casually facilitated session, you’ll have the creative space and like minds to bring your experience to the stage.

FACILITATOR
Michele Cameron, MBA, BSN, RN, CCRC, Director of Clinical Research, Clearwater Cardiovascular Consultants

Vaccines: Your Time, Your Questions, Your Stories

*Hot Topic
When it comes to your specialty, you have specific questions that need to be answered and unique experiences that need to be shared. In this casually facilitated session, you’ll have the creative space and like minds to bring your experience to the stage.
FACILITATOR
Steven Geller, MD, FACP, CPI, Medical Director, PI, Centennial Medical Group

Central Nervous System: Your Time, Your Questions, Your Stories

FACILITATORS
Steve Satek, Founder & President, Great Lakes Clinical Trials
Lauren Chazal, MBA, VP, Global Strategic Alliances, Headlands Research

Endocrinology: Your Time, Your Questions, Your Stories

FACILITATOR
Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research

Nonalcoholic Steatohepatitis (NASH): Your Time, Your Questions, Your Stories

FACILITATOR
Nadege Gunn, MD, Medical Director & President, Impact Research Institute