Breakout Session II

One-hour sessions with multiple topics relevant to your site’s success and sustainability will be presented for your selection. All sessions include active participation with either moderated panels or esteemed presenters that will provide many valuable takeaways.
Expert presenters will provide an in-depth review of challenging topics facing the clinical research industry.
• Focus Group: Diversity Awareness and Issues Related to Your Community
A cross-section of expert panelists will discuss industry and site pain points and identify solutions.
• Collect What You Are Due! Secrets to Budget Optimization
• The Best Staffing Models for Better Quality, Enrollment & Margins
• May the eForce Be With You: Implementing Clinical Trial Technology
• Study Start-up: Beyond Regulatory, Budgets & Contracts
• Elastic Waistbands: When One-Size-Fits-All Central Ad Campaigns Don’t Fit
• A Regulatory Look into Virtual Trials
• PI Oversight: What Is It, Actually?
• It’s Not You, It’s Me: How To Manage Long-term Partnerships
• The Best in the Game: Secrets to Success from Top Enrollers
• Protocol Feasibility: Tactics & Tools for Success
Come prepared to discuss relevant issues and learn best practices. These sessions will be facilitated by an industry expert. Small Groups will be formed to further discuss and identify solutions. Each group will share its findings.
• Creating & Implementing a Sales & Marketing Budget for Your Site
• Dissecting a Clinical Trial Agreement

• Virtual Trials make Virtual Patients: Critical Considerations

Learning LabSM
Focus Group: Diversity Awareness and Issues Related to Your Community
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 initiative to evaluate and measure the inclusion of diverse patients globally. Join this session to learn about the SCRS Diversity Project and participate and provide feedback in an interactive focus group intended to include engagement among participants related to your perspective and knowledge on the enrollment of diverse patient populations at your site and in your region or community.

Anne Marie Inglis, PhD
Senior Director, Clinical Operations GSK

Cassandra Smith, MBA
Associate Director, Patient Engagement Strategy , Janssen

Diana Foster, PhD
VP, Strategy & Special Projects, SCRS

Site MattersSM
Collect What You Are Due! Secrets to Budget Optimization
Hidden and pass-through costs are often missed during budget negotiations, resulting in sites being underpaid for work performed. What does your site need to know to ensure all of the money you are due is allocated? Learn how to effectively manage and track your accounts receivable and invoice for items listed in the contract. Best practices will be shared for collections and the identification of hidden and pass-through costs.

Kristi Etchberger, MBA
Partner, Clinical Research Billing

Shaun Williams, PMP
VP, Investigator Management Solutions, Syneos Health

Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP
Manager, Kelly Willenberg & Associates

Hans Christian Hoeck, MD, PhD
CEO, TrialCare
The Best Staffing Models for Better Quality, Enrollment & Margins
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 re-align job functions to match staffing skills and credentials.

Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Executive Director, Clinical Research, Medix

Ramy Hassan
Site Relationship Lead, Pfizer

Felicia Irvin, MBA, ACRP-CP
Sales & Marketing Director, IACT Health

James Lewis
Director, Barrington James
May the eForce Be With You: Implementing Clinical Trial Technology
Electronic resources such as eRegulatory, eSource, eConsent, CTMS and others are being implemented more frequently by sponsors and CROS. Sites that understand how to embrace the use of new technology are wisely investing in their future success. Learn the pros and cons of various e-Platforms and which are best to utilize for your site so you aren't left behind!

Rick Ward
Vice President, Commercial Operations, Trifecta Clinical

Nancy Fuller, MBA
Shared Investigator Platform Customer Engagement Lead, Cognizant

Jackie Kent
SVP, Head of Product, Medidata

Laku Adedoyin, MEng
CTO, Bio-Optronics

Jennifer Logue Nielsen
Competency Development Specialist, Novo Nordisk

Study Start-up: Beyond Regulatory, Budgets & Contracts

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 can be screened. In this session, sites will share lessons learned and must-do's before starting a study.

Mohammad Ali Millwala, MBA, CPA
CEO, DM Clinical Research

Matt Lowery, BS, ACRP-CP, CCRC
Executive Director, CRBD+

Larissa Comis, MJ
Lead, Shared Investigator Platform, Cognizant

Miriam Noel, BScNH
Center Manager, SIBAmed Studienzentrum GmbH & Co KG
Elastic Waistbands: When One-Size-Fits-All Central Ad Campaigns Don’t Fit
The good news is, the sponsor chose your site based upon its strong enrollment track record and access to a sizeable patient pool. The bad news is, when you submit your recruitment tools and plan for approval, it is rejected due to the use of a central ad campaign. Join to learn how to incorporate central ad campaign tactics into your recruitment plans to ensure your enrollment fate remains in your hands.

Melynda Geurts, MS
Senior Vice President, Site & Patient Engagement , Total Clinical Trial Management

Sarah McKeown-Cannon
Associate Account Director, Langland

Gretchen Goller, MSW
Global Head Patient, ICON

Lance Nickens
President, The Patient Recruiting Agency (TPRA)
A Regulatory Look into Virtual Trials
Remote patient visits becoming a normal part of our study experience is on the horizon. How can sites prepare to meet the challenges of the related compliance requirements? Learn to embrace virtual trials technology and understand how to ensure your site is compliant with regulations.

James Riddle, MCSE, CIP, CPIA, CRQM
Vice President, Institutional Services, Advarra

Karin Gulbrandsen
Sr. Director, Global Clinical Operations U.S. Head, Janssen

AC Corbin
Investigator Site Contracts Director, IQVIA

Eric Klaver
GCP Auditor/CR Trainer, TrialandEric
PI Oversight: What Is It, Actually?
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.

Vivienne van de Walle, MD, PhD, CPI, FAPCR
PI & Director, PT&R

Daniela Cardeal, BSN, MSc
Senior Compliance Process Training and Systems Advisor, Roche

Effie Manos
Associate Director, Neuroscience, Janssen

Ryan Jones, MBA
CEO, Florence Healthcare
It's Not You, It's Me: How To Manage Long-term Partnerships
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.

Karen McIntyre, MSc
Senior Director, Site & Patient Access, Syneos Health

Asha Collins, PhD
Country Head, US Country Clinical Operations, Roche

Whitley Albright, MSN, RN
Site Partnership Manager, Sanofi

Christina Brennan, MD, MBA, CCRC
VP, Clinical Research, Northwell Health
The Best in the Game: Secrets to Success from Top Enrollers
How can your site exceed rercuitment goals and work toward a 100% patient retention rate? Where does this success start? Join this session to hear the secrets to successful enrollment from some of industry's top enrollers. Appropriate for any type or level of site, attendees will learn how to effectively analyze and address risk factors, and ensure that the risk isn't passed on from study to study.

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

Anne-Marie Baugh, RN, MSN
Director, Business Development, Rx Trials, LLC

Gregory Folz, CCRP
Administrative Director, Research, Research Institute of Deaconess Clinic

Steven Satek
CEO, Great Lakes Clinical Trials
Protocol Feasibility: Tactics & Tools for Success
Assessing the feasibility of a protocol for your site is an important task. Failure to assess the right sections of a protocol could cost you financially and impact future study acceptance success. 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.

Ralph Lee
Site Director, Irvine Clinical Research

William Smith, MD, FACC, CPI
Founder, President & Principal Investigator, Alliance of Multispecialty Research

Claudia Schaub
SMO Liaison, Parexel International GmbH

Lauren Chazal, MBA
Vice President of Global Strategic Alliances, Headlands Research

Michael Casey
Executive Director, hyperCORE

Site SolvingSM
Creating & Implementing a Sales & Marketing Budget for Your Site
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 will be shared.

Kathy Cox, MS
President, Interspond, LLC

Chris Hoyle, MBA
Executive Director, Elite Research Network
Dissecting a Clinical Trial Agreement
Clinical trial agreements are lengthy, detailed and 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.

Deena Bernstein, MHS
Sr. Strategic Advisor, Circuit Clinical

Dex Bilkic, MBA, HBSc
Manager, Study Start-up and Patient Recruitment, Bayer

Michael Yon
President, Hylant
Virtual Trials make Virtual Patients: Critical Considerations
It is no secret that digital innovations are here to stay, most immediately in the form of virtual trials. While there are important considerations to be made from an administrative or process perspective, it is equally critical that we consider how patients will be affected. We will discuss how virtual trials affect patient interaction, identify what a hybrid clinical trial is and outline the value of taking a hybrid approach to clinical trials so that patients needs are addressed?

Amanda Rangel, MS, CCRC
VP, Business Development, VirTrial

Anthony Costello
Vice President, mHealthMedidata Solutions Health

Robin Marcus, RN, BSN
CSO, GlobalCare Clinical Trials

Location: See Program for Location Date: October 12, 2019 Time: 3:00 pm - 4:00 pm