Workshop

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

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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

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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

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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

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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

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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.

Erika Moree, MS, SVP, Learning & Development, ProofPilot
Mario Sierra, CCRC, Implementations Manager, ProofPilot

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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

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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

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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

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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

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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

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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

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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

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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.

Mindy Cameron, Patient Insights Board Member, Patient Advocate, Medidata
Phyllisa Deroze, PhD, Patient Insights Board Member, Patient Advocate, Medidata
Dawn Furey, Chief Operating Officer, Circuit Clinical
Alicia C. Staley, MBA, MS, VP, Patient Engagement, Medidata

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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.

Kyle Given, EVP, Account Management, Transformative Pharmaceutical Solutions
Jeff Repper, Executive Vice President, Transformative Pharmaceutical Solutions

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