Site Partnership Symposium - PPD, part of Thermo Fisher Scientific
By Steven Burke PPD, Part of Thermo Fisher Scientific, Lloryn Hubbard PPD, part of Thermo Fisher Scientific, John Manns PPD, part of Thermo Fisher Scientific
*Sites Only Session
Help Us Help You!
Learn how your Site can be Diversity and Digitally Enabled
Come to the symposium to learn more about solutions and strategies your site can adopt, share your feedback on challenges, and let us know what you need from industry to be successful.
Leveraging Site and Patient Experiences to Build Inclusive, Decentralized Clinical Strategies
Join us for a candid and interactive session to share your experiences and expertise on decentralized clinical trial strategies to meet patients where they are, minimize burden, and integrate diversity initiatives.
Sites need more time and resources. Time to spend with patients. Resources to be more efficient. Join IQVIA at our annual Site Partnership Symposium to make connections that make a difference. You will hear from business unit leaders across the company whose roles are to help make your site successful and free you to do the extraordinary things for your patients.
An Exploration of Technological Advancement and the Impact on Sites
Over the past several years, the clinical research industry has seen an unprecedented rise in technological solutions to clinical operations problems. Whether it was the “COVID pivot”, pressure for efficiency, or just plain technological evolution, sponsors and CROs have searched high and low for the perfect use of digital health in the administration of clinical trials, and this is not a trend that will change anytime soon.
But how are we doing? Is it helping? And where should we go from here? After a brief highlight of Janssen’s efforts in digital health innovation, an interactive session will focus on the impact that technology has on sites, the challenges from a site perspective, areas of opportunity, and what actions sponsors can take to improve the overall site experience.
During the breakout session, site participants and Janssen staff will openly discuss specific topics related to digital health. Together, we will consider what factors of technological innovation have the greatest opportunity to improve overall clinical trial experience for sites.
SPEAKERS Sean Cunningham, Strategic Account Lead Director, Global Clinical Operations US, Janssen Sandy Freeman, Director – IDV-CVMR/PH, Global Clinical Operations US, Janssen
Site Partnership Symposium
Where
Regency Ballroom 2
10:30 am - 11:30 am
Master Workshop I (Additional Fee Required)
Make DCT's Work for Your Site
Presented by Medable
Decentralized clinical trials (DCTs) have become the buzzword of the clinical trial landscape. CTTI defines DCTs as those in which some or all study assessments or visits are conducted at locations other than the investigator site via any of the following DCT elements: tele-visits; mobile or local healthcare providers, including local labs and imaging centers; and home delivery of investigational products. With data collection happening in locations other than the traditional brick-and-mortar site, the role of the site is changing. In this workshop, you will learn how you can turn this into a plus and a strength making you the site of choice for sponsors in DCTs.
Mary Costello, Head of Sites and Investigators Network, Medable Fabian Sandoval, MD President and CEO, Emerson Clinical Research Institute Karri Venn, RD, CCRC, COO, Centricity Clinical Research
Data Reusability & Information Exchange to Optimize Trial Operations
Presented by Cognizant
The need for extensive information-sharing between sponsors and sites and the deployment of stand-alone clinical technologies over the last decade has contributed to a complex network of information systems that increase site burden and inefficiencies. In this session, Lestter Cruz, Global Medical Affairs Director and Vishal Janani, Product Director at Cognizant, will outline how a well-designed, secure, and compliant unified platform allows sites and sponsors to reuse data and expedite information sharing across multiple stakeholders to enhance collaboration and optimize trial operations.
Lestter Cruz Serrano, MD, Global Medical Affairs Director, Site Engagement Lead, Cognizant Vishal Janani, MS, Director of Product Management, Cognizant
Utilizing Effective Community Engagement Practices to Drive Enrollment of Underrepresented Populations in Clinical Research
Presented by Janssen
An interactive session for sites to explore best practices, review case study examples and develop the necessary tools for effective community engagement programs.
Luis Arroyo, DEICT Program Manager, Janssen Cassandra Smith, MBA, Director, Diversity & Inclusion in Clinical Trials, Janssen Dinorah Villanueva, MS, MBA, Associate Director, DEICT Processes, Janssen
How the World's Leading Vaccine Site Reduced Protocol Deviations by 40% Using eSource
Presented by CRIO
The global pandemic presented unique challenges to business continuity, highlighting the importance of innovation and adaptability in the operations of clinical trials. Benchmark Research, a nine-site network with a core focus in vaccines, diagnostics, and infectious disease, successfully made the transition from paper charts to eSource during pandemic restrictions and experienced many quantifiable benefits. Join panelists Cynthia Dukes, PA, MT, chief business officer at Benchmark Research and Raymond Nomizu, CEO and co-founder at CRIO, as they discuss how Benchmark addressed the challenges of the pandemic, how eSource enabled them to overcome these challenges, and the long-term additional efficiencies gained using eSource.
Raymond Nomizu, JD, CEO & Co-Founder, CRIO
Patient Engagement: Site Tools That Add Value
Presented by RealTime-CTMS
Patient engagement tools are abundant, but which technologies are best for your site? In this session, learn how to increase engagement with study participants to improve retention, regulatory compliance and data quality with the right patient engagement systems.
Rick Greenfield, BBA-IS, Founder & President, Realtime-CTMS Nathan Levens, Director of Virtual Solutions & Technology, Realtime-CTMS
Deciphering the Protocol Design for Excellence in Site Execution
Presented by ProofPilot
Sponsor protocols are rarely written in a way that helps clinical research coordinators truly understand and prepare for the real life practicalities of conduct. Attendees will be engaged in a collaborative workshop where learners will both contribute and be guided in the best practices for dissecting protocols, formulating key questions, connecting disparate instructions and creating job aids for real world conduct.
Connecting Research Sites & Sponsors Through an Integrated Technology Ecosystem
Presented by Advarra
In this session, Advarra will outline the challenges sites face being overburdened by sponsor-driven technology, and a site “bring your own technology” industry-wide approach to address this burden, meeting the needs of all stakeholders. In the first half of this session, Laura Hilty, VP Strategy at Advarra and Stuart Cotter, VP Product Strategy and Innovation, will share metrics from a recent survey conducted by Advarra and SCRS, and highlight progress made by a new consortium of sites, sponsors, and CROs. Learn how the consortium is working together to connect existing site technology to sponsor systems seamlessly, addressing the duplicative efforts, longer timelines, and reduced patient focus often associated with sponsor-provided technology. The second half of this session will be a highly interactive panel discussion representing each of these key stakeholders. Aidan Gannon, Director Client Services & Innovation, will moderate the panel discussion, which will include: Melissa Holbrook from Velocity Clinical Research, Leslie Ives from Parexel and Rachel Ovens, Boehringer Ingelheim. This lively discussion will provide actionable insight for attendees to take advantage of this connected ecosystem, expand the site BYOT approach further, and discuss with key stakeholders to drive efficiencies across the clinical trial lifecycle.
Stuart Cotter, VP, Product Strategy and Innovation, Advarra Aidan Gannon, Senior Director, Client Services & Innovation, Advarra Laura Hilty, VP, Strategy, Advarra Melissa Holbrook, EVP, Operations, Velocity Clinical Research Leslie Ives, Director, Patient Innovation Center, Parexel Rachel Ovens, MBA, Director, Site Planning & Operations, Boehringer Ingelheim
Clinical Trial Platforms: Site User Experience & Needs
Presented by Merck
This session will review key clinical trial platforms such as EDC, eISF, Central Platform, and SIP to share current offerings and improvements and to better understand current user experience with what's working, pain points and features sites desire to improve site efficiency and ease of use.
Shannon Arnold, RN, MBA, Associate Director, Clinical Systems Implementation Team Lead, Merck Zulma Moreno, Associate Director, Clinical Data Management, Merck Jennifer Sheller, MPH, ACRP-CP, Associate Vice President, Global Clinical Trial Operations Head Monitoring Excellence, Trial Diversity & Site Engagement/Development, Merck
Operational Strategy for Managing High Volume Studies
Presented by Accellacare
After an intense time of COVID-19 vaccine and treatment studies, at-home working, virtual visits, and overall logistical challenges related to the pandemic, keeping staff engaged in day-to-day work is more important than ever. How do we establish deeper strategies to sustain staffing and quality at research sites? In this workshop, we will discuss strategic ways to succeed with the ever-changing needs in clinical research. We will also discuss specific case studies and brainstorm potential solutions together.
Missy Gottschlich, PA-C, IMPAS, Director, Site Networks, Accellacare Brittany Savoca, MS, CCRC, Director, Site Accellacare
Designing More Diverse & Inclusive Trials: Understanding FDA Guidance on Diversity & the Intersection with Technology
Presented by Florence Healthcare
Our industry has struggled to make meaningful progress in addressing problems of access and inclusion for decades. We know that geographic limitations exacerbate socioeconomic disparities and prevent equitable access to care for many groups as pointed out by the FDA’s guidance on Diversity and Inclusion. The guidance also presents sites and sponsors with a roadmap of how to bridge gaps in inclusion that specifically calls out leveraging technology and alternative site selection to expand access. However, strategies that engage one community of patients may push other patients further away. This session will explore ways in which sites and sponsors can partner with patients and technology to develop a game plan that works for multiple stakeholder groups.
Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Affairs, Lipscomb University, Nashville Mapillar Dahn, Founder/CEO, MTS Sickle Cell Foundation Gunnar Esiasson, MBA, MPH, Principal, Florence Healthcare Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Not Another Portal! Designing One Home for Sites
Presented by IQVIA
We hear you, sites. While sponsors, CROs, and service providers continue to roll out the latest and greatest solution to “your” challenges, you roll your eyes, roll up your sleeves, and figure out a way to deal with yet another technology platform complicating your operations. In this interactive workshop facilitated by IQVIA Technologies, we're flipping the script. We want to go beyond quantifying the problem of too many passwords and conflicting systems. We’ll provide a structured environment for attendees to share their ideas on how to run trials better without building an unmanageable array of confounding tech platforms. Let’s step into each other’s shoes as we move beyond portals and build the next-generation clinical-trial ecosystem.
Aruna Adhikari, MBA, MS, Sr. Director of Product Management, IQVIA Technologies Richard Barnes, PhD, Senior Product Manager, IQVIA Technologies Greg Friedman, MBA, MS, Sr. Director, Head of Product and Engineering, IQVIA Technologies Jackie Torres, Associate Site Solutions, Clinical Trial Payments, IQVIA Technologies
Workshop
Where
See Program for Location
2:00 pm - 3:00 pm
Master Workshop III (Additional Fee Required)
Innovative Site Models to Bring Clinical Trials to Patients in Their Communities
Presented by Devana Solutions
An all-star panel featuring Jennifer Byrne, CEO & Founder, Javara Research, Josh Rose, V.P., Head of Clinical Trial Delivery & Strategy, CVS Health Clinical Trial Services and Parexel and moderated by Barry Lake, CEO & Co-Founder, Devana Solutions. Join these industry leaders to explore how they are now strategically leading innovative delivery models including a Community Alliance Network to bring clinical trials to patients at point-of-care in their communities.
Jennifer Bryne, CEO & Founder, Javara Clare Grace, Chief Patient Officer, Parexel Barry Lake, CEO & Co-Founder, Devana Solutions Josh Rose, V.P., Head of Clinical Trial Delivery & Strategy, CVS Health Clincial Trial Services
Developing a Site Plan for Diversity Enrollment: A Practical Approach to Implementing Best Practices
Presented by Parexel
This workshop will bring site, CRO and diversity experts together to guide participants through a step-wise approach to integrating diversity strategy into long-term and study-specific planning. Important areas of consideration to achieve enrollment targets based on therapeutic area will be highlighted, such as hiring a diverse staff, community outreach, and patient profiling aimed at new standards to fulfill diverse participant requirements.
Brandon Doyle, MBA, Associate Site Alliance Director, Parexel Kim Kundert, RN, BSN, SVP, Site Development Services, Total Diversity Clinical Trial Management Fabian Sandoval, Director of Product Management, Emerson Clinical Research Institute Van Johnson, VP, Corporate Strategy, Benchmark Research
What Do Patients Really Think About Site Visits?
Presented by Medidata
Patients are at the center of clinical trials, but they rarely have the chance to share their trial experiences with their sites. Medidata’s Patient Insights Team and Circuit Clinical know patients are eager to share their thoughts on areas that need improvement with sites that are willing to listen. By soliciting feedback, your research site can understand the patient perspective on study operations and site performance, paving the way for optimized patient experiences in current and future studies.
Designing a Patient Care Program Within Your Clinical Trial
Presented by Transformative Pharmaceutical Solutions
Significant progress has been made towards patient centricity in clinical trials, especially with the collection and application of patient feedback into clinical trial design. However, it’s critical to understand that every patient is different and would benefit from a personalized set of options that facilitates their unique experience. In this interactive workshop, we will work through a mock protocol to point out the places where some type of personalized patient engagement/care could be deployed. What options are available and where can a patient be provided with this personalized approach? At the completion of the workshop, attendees will have a framework for designing their own personalized care program for any clinical trial.
Enjoy light fare and beverages while receiving a warm welcome to the Global Site Solutions Summit! Membership Committee chairs will present on How to Maximize Your Summit Experience through our engaging agenda and multiple networking opportunities that are offered daily.
Gain insight into trends and metrics to position sites for success. Current survey data on site finances, staffing, decentralized technology and diverse enrollment will be discussed by a panel of industry leaders. Use the information shared during this solution-focused discussion to make an impactful change at your organization.
Plenary
Where
Great Hall 1-3
5:20 - 5:55
Patient Voice: How Our Work Resonates with Our Patients
In this session, hear feedback from patients responding to how clinical trials are being managed. From benefits and accommodations to advancements in technology, we will hear first-hand how our patients are responding to the experiences being offered to help them through their medical journeys.
Let's talk solutions! Site sustainability is critical when it comes to running a successful clinical trial. Site leaders come together for an interactive panel sharing resources, tools and knowledge on how to create a successful site.
Plenary
Where
Great Hall 1-3
9:30 am - 10:15 am
Tech or Terror: What Does the Exponential Increase in Technology Mean to Current & Future Operations of Research Sites?
Technologist and author Ramy Nassar, a frequent TEDx speaker and creator of disruptive digital products and platforms, leads a panel session on the benefits and challenges of an increasingly digitalized clinical research world. Come hear the perspectives of sites, sponsors and technology providers as they unpack information that is critical to better understanding the rapidly evolving eclinical technology landscape and what it means to daily site operations now…and 10 years from now.
Site Tank is a competition for sites to submit their innovative technology ideas that enhance, empower and improve clinical research operations and transform business models. Join us as Site Tank finalists share how their novel ideas can impact clinical trials, patients and business operations.
FINALISTS
Murtaza Marvi, DM Clinical Research
Ryan Buterbaugh, Research and Me
Kate Marusina, UC Davis School of Medicine
The Site Patient Recruitment Innovation Award (SPRIA) recognizes sites that employ unique strategies to achieve enrollment success. Learn about the concepts and results behind the SPRIA finalists' creative recruitment methods.
FINALISTS
David Rodin, IMA Clinical Research
Michael Clay, Javara Research
Nick Focil, Pfizer
Plenary
Where
Great Hall 1-3
11:45 am - 12:30 pm
Diversity in Clinical Trials Over the Decade, Now & in the Future
The face of clinical trials is forever changed by the increasing emphasis on the importance of diversity and inclusion in clinical research. Join Dr. Jerome Adams, MD, MPH, FASA, Chairman of the Board of Total Diversity Clinical Trial Management and former U.S. Surgeon General, Quita Highsmith, MBA, Vice President and Chief Diversity Officer, Genentech, Dr. Jewel Mullen, Dean of Diversity, Equity and Inclusion at Dell Medical School and Diana Foster, PhD, SCRS, as they discuss their fascinating careers and perspectives on diversity. Appreciate the critical importance of the research site's role in changing the trajectory of diverse enrollment, ultimately impacting the quality of life for underrepresented populations.
How to Get My Site Noticed: Steps for Securing Earned Media
*Recruitment & Retention
For many of us, marketing our studies is not an area of experience. To recruit and retain patients we must understand marketing and what it means to get in front of our target audience. In this session, we will focus on how you can work with sponsors and CROs to secure earned media placements and deliver messages that will position your site and study to get noticed.
FACILITATOR Greg Adams, Director, Clinical Site Management, Pfizer
PANELISTS Blake Adams, SVP Marketing, Florence Healthcare Ezekiel Fink, MD, CMO, Cedar Health Research Riaan van Tonder, Vice President, Site Network, AES, part of Thermo Fisher Scientific
Communications Fundamentals for Stronger Relationships
*BD & Relationships
Hear best practices for establishing rapport and building strong industry partnerships from sites and sponsors. In this session, you will learn how to create valuable, long-term industry relationships by understanding the fundamentals of proactive and timely communication strategies.
FACILITATOR Lele Simmons, VP, Business Development, Flourish Research
PANELISTS Wes Bonner, Chief Relationship Officer, Meridian Clinical Research Lauren Chazal, MBA, Chief Business Development Officer, Headlands Research Lindsey Morales, Senior Manager, Site Centric Solutions , Labcorp Drug Development Nancy Trapp, Senior Director, North America Clinical Operations-Field Management, Novo Nordisk
Improving Study Visit Flow: Creating Efficiencies at Your Site
*Operations
It doesn’t have to be this hard! Learn how to set up and execute your study visit effectively. This round table discussion will be packed with techniques that make a participant's visit less burdensome and improve the experience for the participant and staff.
FACILITATOR Lisa Bjornestad, VP, Clinical Operations, DM Clinical Research
PANELISTS Jean Lucas, MD, Principal Investigator, Lucas Research Jamie Schimmel, MPA, VP, Clinical Research Operations, IMA Clinical Research
Staff Retention: Keeping Your Staff Motivated & Engaged
*Human Resources
Help wanted! Our panel will discuss methods to keep your most valuable assets: your employees. Learn methods for engaging your staff that will keep them long term and create a great company culture. Our panelist will also help you understand how the pandemic has changed the landscape of staffing your site and how to plan for the future.
FACILITATOR Marianne Tadros, ACRP-PM, SHRM-CP, Director of Human Resources and Organizational Development, DM Clinical Research
PANELISTS Kay Scroggins, RN, President/CEO, Clinical Trials of Texas, part of Flourish Research Alexis Shaffer, Sr. Business Development Director, National Life Sciences, Medix Life Sciences
Contracts & Clauses: What They Really Mean
*Legal
In this session, you’ll get the ABCs and 123s of contracts. You don’t need to have a legal degree to understand a contract and its clauses, but you do need to have the tools and insights to know how to identify the major components of a CTA and how to fulfill contractual obligations. Get all you need to know in this session.
FACILITATOR Michael Pierre, Sr. Director of Systems Management, Meridian Clinical Research
PANELISTS Christina Greene, JD, Head, Global Site Agreements, Merck Brian Hunter, MA, VP, Contracts & Trial Management, CNS Healthcare Lori Rich, VP of Strategic Development, Elligo Health Research
Innovative Methods to Revolutionize your Business Development Practices
*BD & Relationships
Revolutionize means to change something radically or fundamentally, so this panel talk is what you need for a fresh and innovative jolt for your site’s business development! Experts will share insights into technology, money, sponsorship, and participant needs. Be prepared to take notes and “level up!”
FACILITATOR Andrew Kimball, MBA, Chief Commercial Officer, Meridian Clinical Research
PANELISTS Kerry Gorman, Head, NA Strategic Site Solutions, IQVIA Alysa Langburt, Director, Business Development, Centricity Research Kerri Mallory, MS, Study Start, Associate Director, GSK
Implementation & Integration of CTMS, eReg, & eSource Platforms
*Operations
Join these industry experts as they share what changes are coming to your trials, what electronic platforms are currently available and what's on the horizon. We'll also discuss what is expected of a site and a sponsor, what is needed to keep your site operations compliant, and how to position your site to be competitive for new studies.
FACILITATOR Raymond Nomizu, JD, CEO, CRIO
PANELISTS Stephanie Abbott, PharmD, Clinical Operations, Innovo Clinical Research-Western Washington Medical Group
Lydia Beaudette, MSc, CCRC, ACRP-PM, Director - Growth & Strategic Partnerships, Centricity Research Stuart Cotter, VP, Product Management, Advarra Jeff Stein, CEO & President, ALSA Research
Onboarding & Training New Staff: Efficient Ways to Ensure Quality & Success
*Human Resources
Bring your new hires on board with intentional action to ensure their success in your company. Learn about successful staff training techniques and how to use what serves your site best. This panel will also discuss how these training techniques will drive quality and efficiency for your staff and your site.
FACILITATOR Cesia Abea, Director of Finance, Clinical Site Partners - a Flourish Research Site
PANELISTS Mike Clay, MSJ, Chief Operating Officer, Javara Penny O'Neal, RN, CCRC, Clinical Development Director, CNS Healthcare Radhika Butula, MIPH, Manager, Medical Oncology Clinical Trials Unit, (MOCTU), CPMCC/Westmead Hospital
New Electronic Health Information & Data-Sharing Initiative: How It Impacts Sites
*Legal
You may have heard about the Trusted Exchange Framework and Common Agreement (TEFCA) exchange program, but do you know what’s changed? In this session, learn all about TEFCA, how your site can benefit from data sharing, and how to ensure you stay compliant.
FACILITATOR David Vulcano, LCSW, MBA, CIP, RAC, VP Clinical Research Compliance & Integrity, HCA Healthcare
PANELISTS Christina Krawiecki, MPH, Sr CRA, Oncology, Merck Luis Magalhaes, MBA, Head of Site Network, Clinerion Scott Whitt, MA, President and General Manager, Triad Clinical Trials
50 Shades of Gray – Remote Monitoring: Who is Accountable for What?
*Operations
Remote monitoring is a reality and sites must understand the various interpretations. This session will highlight areas of responsibility for sponsor and site and what is required to ensure workload and ownership is appropriately managed.
PANELISTS Roman Fishchuk, MD, MSc, CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council Dementric Matthews, Vice President, Global Clinical Operations, Syneos Health Andrew Onikepe, MS, Regional Director of Monitoring Excellence, Merck
Study Budgets 101: Make Sure You Are Getting the Best Budget for Your Site
*Finance
It’s not about building a better mousetrap, but it is about knowing how to build a better study budget. Join this breakout to understand the costs related to clinical trials and learn how to invoice for your study-related activities. Leave with supporting forms and templates that will strengthen your budget negotiations and your bottom line.
FACILITATOR Chris Hoyle, MBA, CEO & Founder, Elite Research Network
PANELISTS Kristen Andrews, Senior Director, Site Partnerships, Labcorp Drug Development Todd Albin, MBA, CEO, Cedar Health Research Kathy Cox, MS, President, Interspond
FDA Inspections: How to Prepare
*Regulatory
Are you certain your site is ready for an FDA inspection? This session will include insights from FDA inspectors and sites that have been inspected. Learn what measures they have implemented to ensure you are inspection ready.
PANELISTS Karri Venn, RD, CCRC,COO, Centricity Research Ana Marquez, MSF, CRCP, CEO, Clinical Site Partners, part of Flourish Research Orlando
*Finance
Find out if your site is missing valuable opportunities for future revenue. Join this discussion to find out how other sites are using tools to track revenue and how they forecast metrics to ensure they are managing their staff and study pipelines.
FACILITATOR Steven Geller, MD, Medical Director, Centennial Medical Group
PANELISTS Todd Engelman, Sr. Manager Clinical Operations, PPD, part of Thermo Fisher Scientific Karin Gulbrandsen, Sr. Director, US Head, Global Clinical Operations, Janssen Anne-Marie Manasier, VP, Business Development, Clinical Site Partners, part of Flourish Research
Recent Direction & Importance of Completion of the Diversity Site Assessment Tool for Site Selection in Studies Enrolling Diverse Populations
*Diversity
Discuss sponsor and CRO philosophies on the importance of site benchmarking through the SCRS Diversity Site Assessment Tool (DSAT). Join us to learn how sites can improve business opportunities in diverse enrollment studies through DSAT methodology.
FACILITATOR Amanda Rangel, MS, Sr. VP Business Development, Total Diversity Clinical Trial Management
PANELISTS Brandon Doyle, MBA, Associate Director Site Alliances, Parexel Lloryn Hubbard, Director, Patient Diversity, PPD, part of Thermo Fisher Scientific
How to Build Strong Relationships of Trust
*BD & Relationships
Join this panel discussion on how to build strong industry relationships and explore the communication fundamentals. Learn how to develop genuine rapport with contacts for reciprocal alliances.
FACILITATOR Dan Otap, Senior Alliance & Partnerships Lead, Genentech
PANELISTS Dana Edwards, CCO, Circuit Clinical Natalie Monegro, MBA, MPH, Lead, Clinical Trial Diversity and Inclusion, AbbVie Casey Orvin, CCO, Cenexel Jeff Repper, EVP, Strategic Site Initiatives, TPS Global
Social Media: Marketing on Facebook, Instagram, Twitter, TikTok, & More
*Recruitment & Retention
Most of us use social media in everyday life to communicate with family and friends. But how can you leverage it to advance your site’s goals? In this session, we will learn about the different types of social media marketing opportunities that are available to sites and how to use them in partnership with sponsors, CROs, and IRBs to present your studies and site in new and creative ways.
FACILITATOR Scott Whitt, MA, President and General Manager, Triad Clinical Trials
PANELISTS Blake Adams, SVP, Marketing, Florence Healthcare Sarah Attwood, Director Of Business Development and Client Services (IRB), Castle IRB Eduardo Mendez, Recruitment Manager, Flourish Research Tarra Shingler, SVP, Global Business Solutions, StudyKIK
Pick Me! Marketing Your Site to Sponsors & CROs & What a Successful Site Looks Like
*BD & Relationships
Are you tired of feeling like you are going to so many pre-site visits, but not getting the study? Join this panel that gives you the playbook for getting your site selected for studies. Learn how to succeed in creating a successful site that will have you choosing which studies to take. Learn how to utilize collaboration and understand the dynamics that get you picked for that study!
FACILITATOR Lisa Dyment, Executive Director, Patient Enrollment Optimization, PPD, part of Thermo Fisher Scientific
PANELISTS Silvina Baudino, Director, Site Strategy, Teckro Anne-Marie Baughn, RN, BSN, MSN, Director, Business Development, Rx Trials Rick Greenfield, Founder & President, RealTime-CTMS Software Solutions Andrew Kimball, Chief Commercial Officer, Meridian Clinical Research
The Evolution of Hybrid Decentralized Trials & the Impact on Site Operations
*Operations
Bracing for impact! This exciting panel discussion will give you new insights on how to assess and receive compensation from DCT trials. Join in the discussion to share what impacts you’ve had with staffing and how to ensure the PI is having proper oversight of the trial. This session will give you tools and expertise to be ready!
FACILITATOR Janusz Kabata, MBA, MD, PhD, CEO, GP4research
PANELISTS Deena Bernstein, MHS, VP, Customer Success, Datacubed Health Todd Greenwood, PhD, MPH, Director, ZS Evidence and Outcomes, ZS Associates Vivienne van de Walle, MD, PhD, CPI, PI & Medical Director, PT&R Dawie Wessles, Chief Medical Officer, Signant Health
Clinical Research Coordinators: Navigating Challenges & Best Practices for Successful Sites
*Human Resources
You may have heard of “The Right Stuff” where astronauts were chosen because of their ability to think clearly in a crisis and take whatever measures needed to deal with the crisis effectively. With the evolution of decentralized trials, CRCs also need to have “The Right Stuff.” Discover what attributes you should be developing in your staff and strategies to ensure success.
FACILITATOR Amber Holst, Sr. VP, Operations, Great Lakes Clinical Trials, part of Flourish Research
PANELIST Audrey Escobedo-Escotto, MD, MPH, Research Director, Emerson Clinical Research
Decentralized Trials: The Good, The Bad & The Myths
*Legal
Decentralized trials are unique and sites still lack clarity with regulatory and budget guidance. In this session, learn how to work within legal parameters with outsourced vendors as well as how to fulfill your contractual obligations. Items such as IP accountability, PI oversight and delegation of authority will be discussed.
FACILITATOR Kelly Sanford, MS, Director, Decentralized Trials Site Operations, IQVIA
PANELISTS Whitley Albright, MSN, Site and Patient Focused Innovation Project Manager, Sanofi Kelly McKee,MS, VP, Patient Registries and Recruitment, Medidata Jamie Schimmel, MPA, VP, Clinical Trial Operations, IMA Clinical Research
We Identified Qualified Participants, Now How Do We Enroll Them?
*Recruitment & Retention
You have qualified participants – now how do you build trust with the participants to bring them into your study? This session will give you non-threatening language and tools to explain your study and bring your participants along the study journey with you through the enrollment process and beyond. Learn strategies so your site has the best opportunity to enroll and retain your qualified participants!
FACILITATOR Mike Clay, MSJ, Chief Operating Officer, Javara
PANELISTS Miaesha Campbell, Sr. Director, Patient Recruitment and Retention, Medpace Nadege T. Gunn, MD, CPI, Principal Investigator, Impact Research Institute Jeff Ramsey, Sr. Director, Patient Experience & Design Innovation, Lilly Eben Scanlon, MBA, PhD, EVP, Customer Adoption, Reify Health
How to Find & Retain New Investigators for Your Trials
*BD & Relationships
If you are in need of investigators for your clinical trials, then this panel discussion will help you understand what motivates other investigators and how you can recruit and retain them for your trials. Learn how to explain the benefits of being an investigator and keep those investigators with you.
FACILITATOR Bruce Rankin, DO, CPI, FACOFP, Medical Director & Principal Investigator, Accel Research Sites
PANELISTS Lydia Beaudette, MSc ,CCRC, ACRP -PM, Director, Growth & Strategic Partnerships, Centricity Research Lestter, Cruz Serrano, MD, Global Medical Affairs Director, Site Engagement Lead, Cognizant Jean Lucas, MD, Principal Investigator, Lucas Research Jennifer Byrne, Founder & CEO, Javara Chris Popple, VP, Strategic Development, Javara
Operationalizing Your Site as a Business: Successful Site Models
*Operations
We know one size does not fit all, so understanding how to set your site up as a business can look different. This panel will present different models of successful sites. Attendees will leave this discussion knowing what components should be measured and how to establish business and goal objectives so your site is sustainable and successful.
FACILITATOR Donna Kostandy, Director, Alliance Unit, PPD, part of Thermo Fisher Scientific
PANELISTS Beverly Cody, Director, Training, Care Access Research Carmen Navarro, MA, CEO, Caribbean Medical Research Center Carlos E. Orantes, President & CEO, Alcanza Clinical Research Jeff Repper, EVP, Strategic Site Initiatives, TPS Global Karri Venn, RD, CCRC, COO, Centricity Research
Training the Next Generation of Clinical Research Coordinators
*Human Resources
The UC Davis Clinical and Translational Science Center (CTSC) recently launched a training program to address the persistent shortage of staff to support clinical trials, increase diversity of the clinical research workforce and provide a re-training opportunity to under resourced communities. In this session, learn how the industry is expanding the pool of qualified staff and how to build a program to model this approach.
PANELISTS Olga Kishchenko, CCRP, Education Program Lead, Clinical and Translational Science Center, UC Davis School of Medicine Kate Marusina, PhD, MBA, Director, Clinical Trials Office, Clinical and Translational Science Center, UC Davis School of Medicine
How to Manage an FDA Inspection & Respond to a 483
*Regulatory
This session will show you how to manage that process and respond to a 483. Learn how to approach the FDA, the requirements necessary respond to future inspection and how to mitigate the impact for future site study opportunities.
FACILITATOR Jennifer Botte, RN, Director of Clinical Services, Remington Davis Clinical Research
PANELISTS Diana Ambrose, Country Clinical Quality Management Lead US, Merck Molly Butler, AD Quality Assurance, PPD, part of Thermo Fisher Scientific
Decentralized Trials – the Myths, the Threats & the Money
*Finance
It’s no secret that there are hidden costs for conducting decentralized trials. Learn what is myth and what is fact in this session that demystifies what your site needs to know to embrace decentralized trials. Plus, discover how to ensure you are getting the maximum reimbursement for ALL activities your site is doing.
FACILITATOR Cheryl-Ann Hawkins, RN, MHA, Chief Operating Officer, Emeritus Research
Hot Topics in Finance Part 1: Recruitment & Marketing, Participant Outreach & Navigator
*Finance
Take part in this roundtable topic that will help you develop a budget proposal that gets your site reimbursed for those outreach activities. Get the maximum reimbursement you are entitled to and make sure you know how to plan and measure your results!
FACILITATOR Ana Marquez, MFS, CEO, Clinical Site Partners
PANELISTS Dan Milam, EMBA, Director, Clinical Trial Partnerships, EQRx Eden Stein, MBA, MSc, PMP, CCRC, Executive Director, Patient Insights & Engagement, Centricity Research
Perfecting Your Sites: How to Set Up a QA/QC Program
*Regulatory
In this session, we’ll discuss the big picture when it comes to quality assurance and how you can adopt quality control systems, practices, and technologies within the site that will help to reduce risks and improve compliance.
FACILITATOR Dan Otap, Senior Alliance & Partnerships Lead, Genentech
PANELISTS Nicholas Focil, MBA, MS, CCRP, CEO, Fomat Medical Research James Riddle, MCSE, CIP, CPIA, CRQM, VP Research Services & Strategic Consulting, Advarra Marianne Tadros, ACRP-PM, SHRM-CP, Director of Human Resources and Organizations Development, DM Clinical
Study Budgets 201: A Deeper Dive
*Finance
As the industry evolves, the hidden costs are increasing. Find out if your site is missing out on trial-related reimbursements. Identify the metrics you need to watch to ensure your site is not only surviving, but thriving.
FACILITATOR Chris Hoyle, MBA, CEO & Founder, Elite Research Network
PANELISTS Meghan Harrington, MS, VP, Clinical Trial Financial Management, Medidata Rochelle Redding, MS, Associate Director, Global Process Lead, Merck
The Sponsor's View on Next Steps for Sites in Diversity Integration
*Diversity
The integration of diversity planning throughout the clinical research enterprise will require Sponsor communication to the site community. This session will explore the progress Sponsors are making in the development of site support services to facilitate enrollment of under represented populations. Attendees will have the opportunity to bring questions and experiences to the group for discussion.
PANELISTS Ruma Bhagat, MPH, Principal Science Leader, Global Health Equity Population Sciences, Genentech Dinorah Villanueva, Associate Director, Diversity, Equity and Inclusion Process Lead, Janssen
Community Outreach: Engaging with the Community to Attract New Participants
*Recruitment & Retention
Clinical research became a top-of-mind issue for general citizens throughout COVID and the importance of this research really hit home with many people. Now is the time to activate your community to keep them interested in current and future studies. In this session, learn about how to conduct community outreach to increase participation and track the impact your outreach can have in your community.
FACILITATOR Fabian Sandoval, MD, President & CEO, Emerson Clinical Research Institute
PANELISTS Jennifer Botte, RN, Director of Clinical Services, Remington Davis Nazneen Qureshi, Director of Patient Recruitment, Accellacare
Metrics That Help Your Site Stand Out
*BD & Relationships
If you can’t measure it – you can’t manage it! This lively panel discussion will give you the capability to compile meaningful metrics for site success. Learn how to establish KPIs that will benefit your site and have sponsors impressed from knowing your numbers.
FACILITATOR Steven Burke, Director, DCT Network Manager, PPD, part of Thermo Fisher Scientific
PANELISTS Lauren Chazal, MBA, Chief Business Development Officer, Headlands Research Audrey Escobedo-Escotto, MD, MPH, Research Director, Emerson Clinical Research Institute Madeline Naylor, MSc, CCRC, Clinical Operations Manager, Clinerion Jennifer Sheller, MPH, AVP, Clinical Operations, Merck
Advancing Technology with Attention to Site & Participant Burden
*Operations
Make your site more robust by decreasing site and participant burden. Panelists will discuss ways to deliver technology training so it is not a strain on sites or study participants and give you expert strategies to keep them engaged and motivated. Join this session to learn how to understand, measure, and utilize the support models and have your site be ready to embrace what’s new in technology.
PANELISTS MarieElena Cordisco, MA, NP-C, APRN, AVP, Clinical Trials, Nuvance Health Mary Costello, Head of Site and Investigator Network, Medable Andrew Gerrard, Product Trainer, Greenphire
How to Create a Warm Culture for Site Success
*Human Resources
Warm culture means creating the right climate within your company and knowing how to use warm operational management philosophies that will translate into site success. This round table talk will give you techniques for building a culture to sustain and grow your site.
FACILITATOR Amber Holst, Director of Clinical Operations, Great Lakes Clinical Trials, part of Flourish Clinical Research
PANELISTS Murali Ramaswamy, MD, FCCP, ACRP-CPI, President & CEO, Pulmonix
I Agreed to What?! Common Things in CTAs Sites May Regret
*Legal
When you are quickly moving through a contract, it’s common to overlook critical information, resulting in commitments that are unplanned. Join industry experts for an interactive discussion related to indemnification, reporting obligations, insurance requirements, legal risk and areas ensuring your site receives the most beneficial CTA possible.
FACILITATOR Adam Penna, JD, Associate Director, Clinical Operations, Merck
PANELIST Shelley Douros, Sr. Director, Clinical Financial Management, Clinical Operations, Medidata Brayden Fraser, MSc, Chief Development Officer, Emeritus Research Jane Myles, MSc, VP, Clinical Trial Innovation, Curebase Jackie Torres, Associate Director, Site Solutions, IQVIA
How to Increase Participant Retention Rates & Compliance
*Recruitment & Retention
Getting participants to enroll in your study is a critical hurdle, but keeping them engaged enough to complete the study can be equally challenging. In this session, we’ll discuss best practices in keeping your participants engaged in the study, reducing dropouts, and satisfying your participants so much that they will come back again.
FACILITATOR Miaesha Campbell, Sr. Director, Patient Recruitment and Retention, Medpace
PANELISTS Emily Goldsher-Diamond, MA, Manager, Human-Centered Trial Design & Strategy, ZS Associates Nadege Gunn, MD, CPI, Medical Director, Impact Research Institute Sarah Piplica, BHlthSci, MPH, Ethics and Regulatory Manager, USC Clinical Trials
How to Best Represent Your Site to Sponsors & CROs with Technology
*BD & Relationships
Be a competitive site. Learn from our expert panelists as they share the pro tips and metrics that will have sponsors and CROs looking at your site for more studies!
FACILITATOR Nicholas Focil, MBA, MS, CCRP, CEO, FOMAT Medical Research
PANELISTS Donna Kostandy, Director, Alliance Unit, PPD, part of Thermo Fisher Scientific Barry Lake, CEO & Co-Founder, Devana Stacie Merritt, MSN, RN-BC, NPD-BC, Director, Ascension St. John Al Pacino, II, President, HealthCarePoint Jean-Marc Tellier, Head, Office of Global Site Partnership, Sanofi
How to Utilize Data to Prevent Participant Dropout
*Operations
Move over content because data is the new king! Experts will discuss the critical importance of data collection, methods to provide valuable data to your partners, and how to use data to keep your subjects from dropping out of the trial. Learn how data will affect your site in an essential panel discussion you will not want to miss!
FACILITATOR Steven Geller, MD, Medical Director, Centennial Medical Group
PANELIST Kyle Hogan, President, Datacubed Health Sarah McKeown-Cannon, Vice President, Growth, Langland
Investigator Compensation Models for Optimal Engagement & Performance
*Human Resources
You had me at compensation! This timely presentation will explain the various compensation models for investigators. Discover what compensation models and methods are effective in driving performance and help you understand why some methods perform better than others.
FACILITATOR Michael Koren, MD, FACC, CPI, CEO, Jacksonville Center for Clinical Research
PANELISTS Daniel Fox, MPH, PhD, Director, Clinical Research, Springfield Clinic William Smith, MD, FACC, CPI, CEO, The Alliance for Multispecialty Marianne Tadros, ACRP-PM, SHRM-CP, Director of Human Resources and Organizational Development DM Clinical
Paperless Systems: How to Ensure Compliance
*Regulatory
The transition from paper-based processing to digital recording requires you to be diligent about the changes you make. In this session, you’ll learn about what you need to do to remain compliant in the digital age, from vendor qualifications to SOP requirements. Learn all you need to know to adhere to the privacy and data requirements that make your site compliant.
FACILITATOR Denise Janus, MBA, CCRP, Chief Clinical Research Officer, Complion
PANELISTS Bree Burks, RN, MSN, VP, Strategy, Veeva Systems Jamie Schimmel, MPA, VP, Clinical Research Operations, IMA Clinical Research
Hot Topics in Finance Part 2: Decentralized Trials & Staffing Costs
*Finance
Uncover the hidden costs of technology and make sure you are budgeting for all your administrative needs. This session will give you the knowledge you need to be financially successful in these areas.
FACILITATOR Ana Marquez, MSF, CEO, Clinical Site Partners
PANELISTS Chuck DeMars, MS, Corporate Director of Budgeting and Contracts, CenExel Greg MacDonald, CPA, CA, CFO, Centricity Research Scott Whitt, MA, President & General Manager, Triad Clinical Trials
Patient as the KOL in Inclusion of Diverse Populations
*Diversity
When we are constantly influenced by social media, patients are not protected from the stories and research they hear from all perspectives. One way we can help is to encourage our patients to be key opinion leaders (KOLs) in their communities to invert the paradigm of how people receive information. When shared through patients, friends, family, and community members can ‘walk in their shoes’ to understand the process, the emotions, and the trauma that comes from being a ‘patient’. Join this panel to learn more about what it means to make the patient the KOL in the inclusion of diverse populations.
PANELISTS Maimah Karmo, Founder, Tigerlily Foundation Jackie Kent, Vice President, Strategy and Special Projectds, SCRS
Please make your way to the Expo Hall to network with Summit attendees, exhibitors, and sponsors! Have fun and create valuable connection opportunities while enjoying a beverage and a variety of appetizers.
Enjoy an evening of fine dining and a toast to industry innovation! Celebrate 2022 SCRS award winners including the coveted Eagle Award, which will be presented to a sponsor and CRO that best represent exceptional site partnerships. We will also announce and celebrate the winners of the Site Patient Recruitment Innovation Award (SPRIA), Site Tank, Christine K. Pierre Site Impact Award, and the Excellence in Patient Centricity Award.
Round Tables: Your Time, Your Questions, Your Stories
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. Cardiology Vaccines CNS Oncology NASH
Feel reenergized and ready to take on the final day of the Summit after a delicious brunch buffet. Join us for breakfast, beverages and entertainment in honor of 10 years of advancing site success!
Over the past decade, collaborations such as SCRS and TransCelerate have provided real solutions to sites. We'll reflect on the early days where TransCelerate member companies came together to identify and create common forms and the development of the Good Clinical Practice (GCP) training and attestation. Discover site-level tools available now with real value stories and use cases to help you implement into your business today.
Plenary
Where
Great Hall 1-3
10:50 am - 11:20 am
The Risk-Based Quality Management Landscape presented by ACRO
ACRO will share findings from a three-year survey project on how RBM and RBQM components are being used across the clinical trial industry. We’ll discuss how sites are impacted and how strategies were shifted from the initial COVID-19 pandemic to now, in the “new normal”.
Plenary
Where
Great Hall 1-3
11:20 am - 11:50 am
The Changing Face of Clinical Trials: Stories of Advancement in Diversity
The landscape of clinical trial participation and the industry’s approach to diversity, equity and inclusion will be forever changed by the increased emphasis on this movement within our society. Experience stories related to the change of the labor force in clinical trials, approaches to underserved populations in enrollment planning and patients' views on participation. Moving stories will emphasize the critical importance of our role in bringing quality of life treatments and medications to all.
