2020 Summit Agenda

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  • October 6

    Tuesday EDT

  • Sponsored by StudyKIK

    The year 2020 will forever be marked as the "Year of the Pandemic" with the impact felt in our personal lives, by our nation, and across the world. Through the tragedy, stories of innovation and creative problem-solving also emerged. How did innovation outlast the emergency? Join this session to hear what solutions emerged that may make a lasting positive impact on clinical research, drug development and our society.

    Plenary

  • Gain insight into operations and metrics to position your site for success. Current data will be unveiled, allowing you to make an impactful change for your organization. This session has always been a favorite at the Summit, and we know you won’t be disappointed this year!
    Plenary

  • Sponsored by RealTime
    Our first networking break celebrates technology in clinical trials. Special host and technology track sponsor RealTime Clinical Trial Management Systems will share Q&A on the future of research technology. Say hello, bring a question, network or even help fellow attendees in this virtual must-attend.
    Networking Opportunity
    Roundtable

  • 1:30 – 2:30
    Reinventing Your Site: During & After COVID-19
    The COVID-19 pandemic has changed clinical research forever. As a result, sites have had to adopt new technologies, train and coach staff, implement new processes, and create an entirely new model of conducting studies. Communicating these changes and new capabilities to sponsors, CROs and patients is essential for ongoing as well as new study opportunities. This session will explore marketing strategies and “the message” sites must create and communicate to stakeholders now and going forward.
    Lisa Bjornestad, Director, Site Alliance, Americas, Parexel
    Christina Brennan, MD, MBA, VP, Clinical Research, Northwell Health
    MarieElena Cordisco, MA, NP-C, APRN, CCRC, AVP Clinical Trials, Research and Innovation, Nuvance Health
    Al Pacino, President, BlueCloud by HealthCarePoint


    2:45 – 3:45
    Site Business Health: Withstanding Disruption During a Pandemic
    Clinical research sites that intimately know their finances and take proactive steps early to prepare for and anticipate disruptions stand a better chance of surviving and even coming out of a disruption stronger. Hear from business owners what strategies they took prior to, during and following major disruptions that resulted in surviving and even thriving.
    Kay Scroggins, RN, President & CEO, Clinical Trials of Texas
    William Smith, MD, MBA, CEO, Alliance for Multispecialty Research
    Christin L. Trujillo, Financial Consultant, Skytale Group
    Emily Wike, Director, Strategic Partnerships, Devana Solutions
    Amanda Wright, VP, Javara
    Breakout
         Business Development

  • Track Category Sponsored by SubjectWell

    1:30 – 2:30
    Diversity in Clinical Research-The Time is Now
    What steps have you taken to address diversity in clinical research? We are past the point of defining the issue and discussing ideas, now is a call to action. The panel of industry representatives will provide insights into the actions in progress and what we can do as the clinical research community.
    Dan Milam, Vice President, Global Engagement, SCRS
    Alicia C. Staley, Senior Director, Patient Engagement, Medidata Solutions a Dassault Systèmes company
    Altair Silva, Director, Patient Recruitment Strategy, Parexel
    Lorena Kuri, Head, Diversity Strategy, Bristol-Myers Squibb
    Jackie Kent, EVP, Head of Product Medidata Solutions a Dassault Systèmes company

    2:45 – 3:45
    Enrollment Wizardry: How to Support Enrollment Before the Study Even Starts
    Enrollment begins before the study starts! This session will provide you with tools needed to maximize lead time to ensure strong enrollment and hit milestones from the get-go. Patient pre-screening, recruitment campaign best practices, and what gets and keeps patients engaged will be addressed.
    Alexa Florea, BS, PMP, Country Clinical Operations Leader, Roche
    Steven Geller, MD, FACP CPI, Medical Director, Centennial Medical Group/RX Trials
    Gretchen Goller, MSW, Global Head, Patient Recruitment and Retention Solutions, ICON
    Lance Nickens, President, The Patient Recruiting Agency
    Breakout
         Recruitment & Retention

  • Track Category Sponsored by CRIO

    1:30 – 2:30
    Site Management Pressure Points: Lessons Learned & Best Practices
    We learn best from our mistakes. In this session, managers will share challenges experienced, what they did to pivot when mistakes were made, lessons learned and how they embraced change to survive and succeed. Challenges related to the COVID-19 pandemic will be highlighted and discussed.
    April Coburn, BA, MLA, Senior Manager, Study Start-Up Delivery – Americas , PRA Health Sciences
    Felicia Irvin, MBA,Director of Sales and Marketing, IACT Health
    Matt Maxwell, MS, MBA, CEO, Accel Clinical Services
    Boris Nickolov, MD, CEO, IMIC Research
    Kathy Scott, Assoc. Site Alliance Director, Parexel



    2:45 – 3:45
    Scaling Sites & Networks: Methods for Success
    How does a site expand into new therapeutic areas or grow to add new sites? Hear from sites that have successfully done both to learn what triggers to look for and pitfalls to avoid so that your efforts to grow and expand succeed.
    Deena Bernstein, MHS, SVP Network Development, Circuit Clinical®
    Wes Bonner, VP, Strategic Development Meridian Clinical Research
    Scott Palmese, Senior Director Site Mobilisation, ICON
    Claudia Schaub, Site Alliances Assoc. Director, Strategic Site Network Access, Parexel International GmbH
    Breakout
         Site & Study Operations

  • Track Category Sponsored by RealTime

    1:30 – 2:30
    Remote Monitoring: The New Normal
    Remote monitoring is not a new concept, however, the impact of the COVID-19 pandemic resulted in widespread adoption almost overnight. During this session speakers will provide regulatory, financial, and operational considerations for the widespread adoption of remote monitoring.
    Larissa Comis, MS, Product Lead, Shared Investigator Platform, Cognizant
    Nicholas Focil, MBA, CEO, FOMAT Medical Research
    Karin Gulbrandsen, Sr. Director, U.S. Head, Global Clinical Operations, Janssen
    Henry Kravchenko, CEO, Clinical.ly



    2:45 – 3:45
    Virtual Trials: Budgeting & Contracting for ” The New Normal”
    You’ve done the work and you took the COVID-19 curveball in stride, changing course to accommodate remote visits to keep your trials moving forward. Now it’s time to get paid. What unique factors should you keep in mind when billing for remote visits and other elements of decentralized clinical trials (DCTs)? How do you navigate payment amidst sudden and urgently needed changes to protocol? This session will identify best practices to ensure full and fast payment.
    Candi Barlow, MSN, CTN, RN, Senior Account Manager, Clinical Research, Bio-Optronics
    Alex Morillo, MBA, Program Director, Biomedical Research Alliance New York (BRANY)
    Joshua Rowell, Senior Director, SSU and Regulatory, Syneos
    Holly Wilson-Leslie, MBA, Sr. Solution Consultant, Clinical Trial Financial Mgmt, Medidata Solutions, a Dassault Systèmes company
    Breakout
         Technology

  • Summit Roundtable: Site Landscape
    Mara DiMattia, Assoc. Director of BD, Integrative Research Associates
    Kerry Gorman, Director, Strategic Site Solutions, IQVIA
    Networking Opportunity
    Roundtable

  • Sponsored by StudyKIK

    The Site Patient Recruitment Innovation Award was launched in 2014 to recognize sites that utilize innovative strategies to achieve enrollment success. In judging submissions, the emphasis is placed on innovative patient-directed initiatives that are unique, effective, and take into account the response of the campaign. The finalists will present their innovative recruitment plans to an audience of sites, sponsors and CROs attending the Global Summit. For the first time, the 2019 SPRIA Europe and Asia-Pac winners will join us on stage to share their winning recruitment plans to kick off the Global SPRIA presentations.   Learn more about SPRIA at the Global Site Solutions Summit.  For questions or comments, please contact SPRIA@myscrs.org.
    Learn More...


    SPRIA Finalists:
    Cindi Nellis, Clinical Trials of Texas
    Doug Surowitz, Health Awareness
    Dr. Naomi Sinclair, The Skin Hospital

    Judges:
    Karen McIntyre, Syneos
    Bhavna Iyer, OncaCare
    Casey Orvin, StudyKik (Sponsor)


    Sponsored by TrialScout

    Site Tank, modeled after the popular television show, "Shark Tank," provides a platform through which sites can put on their innovator hats and share technology ideas that enhance, empower, and improve their operations and transform their business model.  Site Tank provides a platform through which sites can put on their innovator hats and share technology ideas that enhance, empower and improve research operations and transform business models. Learn more about Site Tank at the Global Site Solutions Summit. For questions or comments, please contact sitetank@myscrs.org.
    Learn More...


    Site Tank Finalists
    Lukasz Wiech, AES - Synexus Warsaw
    Stephanie Abbott, Western Washington Medical Group

    Judges
    Darren Cowan, Pfizer
    Bill Tobia, Clinstruct
    Deena Bernstein, TrialScout (Sponsor)
    Plenary

  • October 7

    Wednesday EDT

  • Sponsored by BlueCloud

    Does the General Data Protection Regulation (GDPR) and modern USA data protection regulations affect you?

    Attend this event to learn how GDPR and state-by-state data protection regulations like the California Consumer Privacy Act (CCPA) affect healthcare and clinical research business including sites, sponsors, CROs, universities and other industry stakeholders and what you can do today to position your business during and after the COVID-19 pandemic. There will be 2 “live” drawings each for a $100 cash card at the end of the session! Must be present to win!

    Networking Opportunity

  • Welcome to day two of the Global Site Solutions Summit! Come hear from SCRS's leadership team on what it means to be an SCRS Member, as well as the tremendous progress the Diversity program has made this year.
    Plenary

  • Diversity, inclusion and equity in clinical trials has been an ongoing issue in clinical trials despite numerous calls to action. In this session SCRS, FDA and industry representatives will discuss the critical importance of this issue specifically as it impacts the clinical research site. The ongoing work of the SCRS diversity project will be high lighted along with the launch of the industry standard that has been validated and designed by the working group, to measure and assess the sites individual assessment of best practices in diversity.

    Plenary

  • Our industry thrives on relationships, so take advantage of the break to make new connections, catch up with colleagues and keep the collaborative spirit alive.

    Summit Roundtable: Diversity in Clinical Trials
    Julia Yegorova, Project Lead for Advancing Inclusive Research, Genentech
    Karen McIntyre, MSc, Executive Director, Syneos Health
    Networking Opportunity
    Roundtable

  • Track Category Sponsored by WCG

    1:30 – 2:30
    Negotiating Like a Pro: The Low-Down on Study Budgets
    As study budgets become more complex and less transparent, site staff need to become increasingly savvy with their negotiation tactics. Whether you have someone who manages your budgets or not, this session will provide an overview of all-things-budget including pass-throughs, overhead, procedural justification, and how to ask for a higher budget and actually get it.
    Melynda Geurts, MS, SVP, Business Operations, Total Clinical Trial Management
    Hans Christian Hoeck, MD, PhD, CEO, Trialcare Research
    Ana Marquez, MSF, CEO, Clinical Site Partners, LLC
    Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager, Kelly Willenberg & Associates


    2:45 – 3:45
    Virtual Trials 101: The Nuts & Bolts of Remote Practices
    Whether or not your site is ready for virtual trials, they’re here. This reality was blasted home to us all as COVID-19 circulated the globe and forced us to embrace remote trials…whether we liked it or were ready, or not. This “nuts and bolts” session will walk you through everything you need to know from insurance considerations and budget considerations, to operational challenges and how to navigate unforeseen.
    Kim Kundert, RN, BSN, VP Operations, VirTrial
    Kamala Maddali, DVM, PhD, Vice President, Strategic Alliances and Collaborations, Deep Lens
    Chris Pitcherella, MS, MBA, Director, Clinical Site Operations, Pfizer
    James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Institutional Services and Strategic Consulting, Advarra
    Breakout
         Budget, Contracts & Finance

  • Track Category Human Resources & Legal, Sponsored by Medix
    Track Category Recruitment & Retention, Sponsored by SubjectWell


    1:30 – 2:30
    Driving Site Success with Staff Success
    With the recent changes and destabilization in the clinical research industry due to COVID-19, the value of having an outstanding site staff cannot be overstated. Successful sites have organized, well thought-out and thoroughly documented processes for hiring, onboarding, and training staff. Learn what it takes to create and maintain a top-notch site staff.
    Todd Albin, MBA, CEO, Cedar Health Research
    Molly Downhour, MHA BSN NEA-BC OCN CCRC, Executive Director Clinical Research, Medix
    Lindsey Morales, Senior Manager, Site Partnership, Covance
    Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research



    2:45 – 3:45
    Diversity in Clinical Trials From an Investigator’s Perspective
    Michael Koren, MD, FACC, FAPCR, CPI, CEO, Jacksonville Center for Clinical Research
    Breakout
         Human Resources & Legal
         Recruitment & Retention

  • Track Category Sponsored by Advarra

    1:30 – 2:30
    Quality Management: Not Only the Sponsor’s Responsibility!
    ICH guidelines put the responsibility of quality management squarely on the sponsors’ shoulders. But that doesn’t mean sites shouldn’t have their own quality management plan! Understand the importance of quality management at the site level and learn how to set up your own quality management plan.
    Stephanie Berger, Director, Clinical Research, Urology Clinics of North Texas
    Julia Brenner, MHA, Finance & Regulatory Manager, Coastal Pediatric Research
    Annabel Elliott, Senior Manager, Quality Assurance, Accellacare
    Nicole Huff, SSGBC, ACRP-CP, CCRC, Senior Study Coordinator, Training and Compliance Officer, Suncoast Neuroscience Associates



    2:45 – 3:45
    eSolution Innovation & Regulatory Considerations
    Implementing eRegulatory, eSource and other patient-facing technology that allows clinical trials to move to a remote or hybrid model is on the rise. This is thanks in part to COVID-19, yet this path was paved long before the pandemic began. Join this session to understand the hurdles encountered by those who have already adopted these technologies, and navigate the related regulatory considerations.
    Rick Arlow, Founder & CEO, Complion
    Williams Dirkes, MD, MBA, President, SentralBinders
    Tam Nguyen, PhD, MBA, FRSHP, FIML, Deputy Director of Research, St Vincent’s Hospital Melbourne - Australia
    Raymond Nomizu, JD, CEO, CRIO
    Breakout
         Regulatory & Compliance

  • Track Category Sponsored by Realtime

    1:30 – 2:30
    Effective Technology Management Approaches to Boost Your Site
    Technology can drastically improve efficiencies and processes if adoption and integration keep both the site and patient in mind. Sponsors, CROs and Solution Providers must keep site burden in mind when deploying new technology to ensure its success. Join this session to learn how to problem-solve and effectively adopt technology for the benefit of all parties.
    Anna Argyris, MSHS, CCRP, Director, Site Solutions, Veeva
    Jackie Kent, EVP, Head of Product, Medidata Solutions a Dassault Systèmes company
    Casey Orvin, Senior VP of Pharmaceutical Relationships, StudyKIK
    Rick Ward, VP, Commercial Operations, Trifecta Clinical



    2:45 – 3:45
    Innovative Recruitment Tools: The Expansion of Telemedicine
    Tele-trials and remote visits are becoming a reality as attention shifts to reducing patient travel time and increasing patient flexibility. Join this session to learn how to successfully implement telemedicine and remote visit practices as a recruitment tool for your site.
    Peter Falzon, President & CEO, Ripple Science
    Michael King, Senior Director, Sanofi
    Robin Marcus, RN, BSN, CSO, GlobalCare
    Amanda Rangel, MS, CCRC, EVP, Virtual Trial Solutions, VirTrial
    Breakout
         Technology

  • Our industry thrives on relationships, so take advantage of the break to make new connections, catch up with colleagues, and keep the collaborative spirit alive.

    Summit Roundtable: Budgets & Contracts
    Andre Beukes, BProc (Law), Sr. Director, Business Development, Syneos Health

    Summit Roundtable: HR & Legal

    Summit Roundtable: Regulatory and eSolutions
    Mara DiMattia, Assoc. Director of BD, Integrative Research Associates

    Summit Roundtable: Technology
    Networking Opportunity
    Roundtable

  • 2020 is an unusual year. But, it has provided us with an opportunity to improve the ways of working within our industry. Join senior leaders from TransCelerate member companies as they discuss the importance of coming together as an industry (Sites, Patients, Sponsors, Technology Partners, and more) to address unexpected challenges we face today and better our ways of working for the future.
    Plenary

  • October 8

    Thursday EDT

  • As we begin our third day of the Global Site Solutions Summit, Hear from the SCRS project team share an update on the exciting initiatives and special programs SCRS is known for.
    Plenary

  • The year 2020 will forever be marked as the “Year of the Pandemic” with the impact felt in our personal lives, by our nation, and across the world. Through the tragedy, stories of innovation and creative problem-solving also emerged. How did innovation outlast the emergency? Join this session to hear what solutions emerged that may make a lasting positive impact on clinical research, drug development and our society.
    Plenary

  • Summit Roundtable: Oncology
    Sandy Smith, Vice President, US Oncology Research & Clinical Services
    Archana Sah, Clinical Operations Executive, Roche

    Summit Roundtable: COVID-19 Impact
    Steve Satek, President, Great Lakes Clinical Trials
    Networking Opportunity
    Roundtable

  • Track Category Sponsored by WCG

    1:30 – 2:30
    Hidden Costs: Remote Monitoring & How to Budget for It
    As industry continues to embrace and transition to remote monitoring, the potential staffing and financial burdens on sites mount. This session will help you evaluate the costs and value-add of remotely monitored trials, and understand what line items to keep in mind when negotiating study contracts and budgets.
    Jennifer Bush, Sr. Director, Life Sciences Product Strategy, Oracle
    Ryan Jones, MBA, CEO, Florence Healthcare
    Heather Kemp, Consultant, Trial Capabilities Business Operations, Lilly
    Al Peters, Managing Partner, ClinX


    2:45 – 3:45
    Lessons from the Trenches: How COVID-19 Reshaped Study Budgets
    The entire world, including the clinical research industry, has been turned upside down by the COVID-19 pandemic. With trials halted or closed to new enrollments, increased remote monitoring, staff lay-offs and more, we have entered a new paradigm that we must learn to navigate. Looking in the rearview mirror shows us new budget considerations that must be accommodated. This session will help you navigate “the new normal” so you are prepared and informed in the future.
    Catherine Click, Director, Clinical Pricing & Analysis, Greenphire
    Eric Cole, Local Study Manager, AstraZeneca
    Karen McIntyre, MSc, 1st Executive Director, Syneos Health
    Steve Satek, MBA, Founder & President, Great Lakes Clinical Trials
    Breakout
         Budget, Contracts & Finance

  • 1:30 – 2:30
    Future Therapeutic Trends: Considerations When Expanding into New Indications
    Looking to expand into other therapeutic indications? Your business development must extend beyond your usual efforts and feasibility questionnaires. As pipelines shift direction and new therapeutic area opportunities are identified, discover what proactive steps can be taken to diversify your therapeutic portfolio and position your site as a leader in your desired field.
    Chris Hoyle, MBA, Executive Director, Elite Research Network
    Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research



    2:45 – 3:45
    Common Contract Mistakes & How to Correct Them
    Big or small, most contract mistakes are usually uncovered when you come face-to-face with a problem. This session will walk sites through the most common mistakes found in clinical trial agreements (CTAs) and the steps you can take to resolve them, or avoid them altogether.
    Luke Goodpaster, Senior Project Manager, WCG-PharmSeek
    Matt Lowery, BS, ACRP-CP, CCRC, Executive Director, CRBD+
    Michaela Vancova, Ing., MPH, CRCP, President & Owner, Slovak Research Center
    Vivienne van de Walle, MD PhD CPI, Director, PT&R
    Breakout
         Budget, Contracts & Finance
         Business Development

  • Track Category Regulatory & Compliance, Sponsored by Advarra
    Track Category Recruitment & Retention, Sponsored by SubjectWell

    1:30 – 2:30
    Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained
    If centralized and remote site monitoring (RSM) were not yet on your radar, the COVID-19 pandemic brought it to your doorstep. But what exactly are they and what do they mean for sites? Further, how does all this relate to risk-based monitoring (RBM)? In this session you will hear lessons learned from experience and understand what sites should expect as a site from the future of monitoring.
    Beenu Kapoor, MBA, MS, Vice-President, IQVIA
    Summer Iverson, MSHS, CCRA, Process & Standards Lead Global Site and Study Operations, Pfizer
    Melissa Poindexter, RN, BSN, President, Advances in Health Research
    Shivani Shah, MS, Director of Operations, DM Clinical Research


    2:45 – 3:45
    Sustaining Patient-Centricity Amidst Adversity
    Achieving patient centricity is easier said than done, yet it is important that all stakeholders strive to remain patient-centric even when the going gets tough. This session will highlight how stakeholders maintained patient centricity through the COVID-19 pandemic, including strategies deployed and the resulting outcomes.
    Miaesha Campbell, Director, Patient Recruitment and Retention, Medpace
    Ivor Clarke, CEO, SubjectWell
    Scott Gray, President & CEO, Clincierge
    Chrystal Oley, Site Development Lead, AstraZeneca
    Breakout
         Recruitment & Retention
         Regulatory & Compliance

  • Track Category Sponsored by CRIO

    1:30 – 2:30
    Are Your Key Performance Indicators Aligned with Sponsor Expectations?
    What are key performance indicators (KPIs), and how can they be utilized to operationalize your site and successfully market your strengths to sponsors and CROs? Join this session to learn how to ensure your KPIs are aligned with sponsor expectations and how to engage them in marketing efforts.
    Anne-Marie Baughn, RN, BSN, MSN, Director, Business Development, RxTrials
    Barry Lake, CEO, Devana Solutions
    Chris Monaghan, Associate Director, Site Strategy, ClinEdge
    Earl Seltzer, Senior Director, Covance


    2:45 – 3:45
    What Sponsors are Really Looking for in Your Site Feasibility Surveys
    You’ve found the perfect study for your site, and you completed the site feasibility survey on time…just to find out two weeks later that you didn’t make the cut. Why? What additional information or tactics would have improved your odds? Participate in an interactive feasibility exercise to help you better understand what sponsors and CROs are looking for and what sites should know when completing feasibilities.
    Sean Cunningham, MBA, Director, Strategic Account Lead, Janssen
    Greg Folz, CCRP, Adminstrative Director, Research Institute of Deaconess Clinic
    Marisa Rackley, BS, MHA, PMP, Director, Vertex
    Łukasz Więch, MBA, Partnership Manager, Accelerated Enrollment Solutions
    Breakout
         Site & Study Operations

  • Summit Roundtable: Hidden Costs & Budgeting

    Summit Roundtable: Site Business Development
    Mara DiMattia, Assoc.Director of BD, Integrative Research Associates

    Summit Roundtable: Recruitment & Retention

    Summit Roundtable: Site Operations & Expectations
    Networking Opportunity
    Roundtable

  • With the COVID-19 pandemic, the impact on clinical trials is unmistakable. Digital innovations that might have once taken months or years to be adopted have been integrated into practice in days or weeks. Digital operating models - such as telemedicine, remote monitoring, and synthetic controls that have been discussed and piloted endlessly are now enabling clinical trials to move forward. Even when the COVID-19 outbreak is contained, it’s unlikely these digital transformations will go away. This session will explore how sites, sponsors, and CROs are embracing new technologies and digital operating models while positioning themselves for success in the long term.
    Plenary

  • October 9

    Friday EDT

  • This session examines trends impacting and transforming drug development performance and economics and discusses how sponsors, CROs and investigative sites are adapting to these trends. Trends examined include digital disruption, emerging new sources of patient data and new clinical trial execution models.
    Plenary

  • Sponsored by Sanofi
    Networking Opportunity

  • Celebrate as SCRS presents the Eagle Award to the CRO and Sponsor that are most dedicated to outstanding leadership professionalism, integrity, operational excellence and committed to advancing the clinical research profession through strong site partnerships. Voted on by sites from across the globe, this event honors a site-focused approach to clinical trial management. Sponsored by Trifecta

    T.J. Sharpe and Dave Aizer are late-stage melanoma survivors. They'll share their stories, and how they both shifted from fear and despair to strength, purpose and gratitude. Additionally, T.J. and Dave both received clinical trials and they credit those trials with saving their lives. They'll recount their trial experiences and the profound effect the trials had on their physical and mental wellbeing.

    The winners of the Site Patient Recruitment Award (SPRIA), recognizing a site that has developed and implemented an innovative patient recruitment program, and Site Tank, recognizing a site that has developed an innovative technology solution for clinical research, will be announced and celebrated.

    In honor of Christine Pierre, founder of SCRS, the esteemed Christine K. Pierre Site Impact Award will be presented to an industry leader who has made an extraordinary contribution to furthering the voice of the clinical research community.

    Plenary

  • Join TJ and Dave to continue the discussion of patient perspectives on clinical research. Bring your questions and examples of your own experiences.
    Plenary

  • October 12

    Monday EDT

  • October 13, 2020
    9:00 – 10:00 UTC+8

    The COVID-19 is affecting 213 countries/territories and infecting 25,655,400 cases globally as of September 1, 2020. Taiwan is a crowded country and close proximity to China, the epicenter of COVID-19. Nevertheless, it is one of the few countries with the lowest number of cases (20 per million population) and 396 of 488 cases (81%) were imported from abroad. Given the continual spread of COVID-19 around the world, understanding the actions that were implemented in Taiwan and assessing the effectiveness of these actions in preventing a large-scale epidemic may be instructive for other countries. Besides, healthcare personnel are at the front line of care and are exposed to occupational hazards that place them at risk of infection. The US CDC reported on August 31, 2020 that more than 149,195 healthcare personnel had been infected with COVID-19 with 670 deaths. In this 45-min talk, I will explain Taiwan’s national policy and how we implement in daily practice at hospital level. The goal was to contain community transmission and achieve zero tolerance for COVID-19 infections in healthcare personnel and no outbreak in the hospital. COVID-19 occurred just before the Lunar New Year. Taiwan quickly mobilized and instituted specific approaches for case identification, containment, and resource allocation. Guidance or policy were announced and adjusted timely. Border control to prevent importation include health alert/restriction/ban and entry restriction. Community surveillance and epidemiological investigation, hand hygiene, universal masking or social distance, risk-based home isolation/quarantine/health self-management, policies toward schools or mass gathering aimed to contain community transmission. The government addressed the issue of disease stigma and compassion for those affected by providing food, frequent health checks, and encouragement for those under quarantine. Case definition, SARS CoV-2 RNA PCR targeting testing and enhanced screening program, contact tracing, patient divergence and transfer, isolation of the sick and quarantine of those at risk aimed to protect healthcare settings. The government also took an active role in resource allocation, including surge capacity of mask production and rationing its distribution. Information technology was integrated for risk assessment and containment. For more stringent control and avoid intentional deny important epidemiologic history, the personnel information for oversea travel and contact of confirmed cases are integrated with the National Health Insurance database. From hospital perspective we initiated or upgrade infection prevention and control measures early and timely risk-adjusted, integrated national and institutional policy/practice which includes control at the source, control along the path, control at the person level, etc. In addition, we used a hospital-wide web-based health surveillance integrated with a risk-based management algorithm and molecular testing of asymptomatic healthcare personnel. In conclusion, Taiwan effectively delayed and contained community transmission by leveraging experience from 2003 SARS epidemic, prevalent public awareness, a robust public health network, support from healthcare industries, cross-departmental collaborations and advanced information technology capacity. However, the challenge remains in the context of COVID-19 moving in a borderless world. We must act and act together locally and globally.
    Plenary

  • October 13

    Tuesday EDT


  • Increasing Enrollment and Diversity By Treating Patients Like Customers (RR)
    Patients of all races and ethnicities are consumers and they are accustomed to being able to engage providers with ease and on their own terms. In this session, get insights into how other industries inform and engage consumers and explore how you can apply those same techniques to your next study.
    Ivor Clarke CEO, SubjectWell

    Virtual Trial Capable – The Complete 2020 Guide (TECH)
    Do you work at a site and have concerns about competing for DCT protocols? Join this live training and gain a competitive edge by becoming Virtual Trial Capable Certified and learn the skills to adequately manage Virtual Visits with “Web-side manner” etiquette.
    Amanda Rangel, MS, CCRC, EVP, Virtual Trial Solutions, VirTrial
    Workshop
         Recruitment & Retention
         Technology

  • Summit Roundtable: Cardiology
    Michele Cameron, Director of Clinical Research, Clearwater Cardiovascular Consultants
    Karri Venn, President, LMC Diabetes & Endocrinology
    Networking Opportunity
    Roundtable

  • *Sites Only Session


    COVID-19: Impact on Clinical Research Operations and a Path Forward

    We have all felt the impact of COVID-19. Whether it is in our professional or personal lives, our “normal” way of operating is no more. But where do we go from here? What happens when the threat is diminished to a manageable degree? Will we go back to business as usual, or have the ways of working been permanently altered?

    In this session, we will discuss the impact of COVID-19 on clinical research operations from both a site and sponsor perspective. After an initial discussion of the efforts Janssen is taking to combat the impact of this pandemic, we will break into smaller groups to discuss the impact on patients, sites, and sponsors, discuss what sites and sponsors need from each other to continue providing clinical research as a care option for patients, and how we can work together to emerge from this pandemic even stronger than we were before.

    Site Partnership Symposium

  • October 14

    Wednesday EDT


  • Clinical Trial Financial Management Technology 101 Workshop: Leveraging Technology to Lower your Site Burden ($, TECH)
    Technology is changing the way clinical trials are being conducted. In this session, you will learn the core Clinical Trial Financial Management technologies that are powering clinical trials today and how they are improving the site experience. In addition, we will talk through some of the more advanced technologies that are becoming mainstream and how you can engage with your CROs and/or Sponsors to ensure they are leveraging these technologies.
    Jeffrey Kearney, VP, Product Management Payments, Medidata Solutions, a Dassault Systèmes company
    Tom Creswell, Director Product Management, Medidata Solutions, a Dassault Systèmes company
    Shelley Doruos, Director of Product, Clinical Trial Planning & Budgeting, Medidata, a Dassault Systèmes company

    Looking to be Acquired and What to Expect
    This will be an open discussion about site acquisitions. We will share several critical issues that you need to be aware of as you undertake this process. This will include discussion of essential information for evaluation. There will be discussion of basic systems that will be expected to optimize your value.
    William B. Smith, MD, CEO, Alliance for Multispeciality Research
    Neil McCarthy, Managing Director, Fairmont Partners Investment Banking
    Sean Karamchandani, Partner, Presistance Capital Partners
    Kumar Muthalagappan, CEO, Chairman, Oncacare
    Workshop
         Budget, Contracts & Finance
         Regulatory & Compliance
         Technology

  • Summit Roundtable: CNS
    Networking Opportunity
    Roundtable

  • *Sites Only Session


    No going back, preparing sites for trials of the future
      Diversity in clinical trials: how do we ensure that trial participants represent the true disease population?
      Here to stay: what important trends have been accelerated due to COVID? Perspective from sites
      Operationalizing a protocol: why it’s important to hear from the people doing the work
    Site Partnership Symposium

  • October 15

    Thursday EDT


  • The Future Site Business: Adopting Change and Creating a Site Business Around Trial Execution ($, BD, & TECH)
    Building and scaling a site business during COVID-19 is challenging even now, while studies are beginning to soar again. Over the past year, many sites have been put to the test – navigating uncharted waters and managing day-to-day operations through a pandemic. As many sites have struggled to “break out” from the mold and step into the future, this workshop will give them a glimpse into the possibilities and opportunities that are created as we adopt change and innovation. We will go into detail showing flow charts, budgets, and templates that sites can utilize in order to integrate key site business practices within the current business model. The purpose of this workshop will be to enable research site attendees to better understand the big picture of how to operate, recruit patients, identify study opportunities, maximize their staff, and utilize the right systems to not only survive, but even thrive. Because with many of the cons outweighing the pros of being a site early this year, we believe there are many pros they can leverage that will enable new revenue opportunities as a business owner or manager.
    Christian Burns, President & Co-Founder, ClinEdge and BTC
    Sean Stanton, Strategic Sourcing and Business Growth at C2N Diagnostics

    Updating Sponsor Negotiations to Accommodate a Changing Trials Landscape ($, BD, OPS, TECH)
    In this talk, site leaders will evaluate creative ways to ensure their site is poised to receive the maximum amount from Sponsors while negotiating clinical trials. Further, attendees will understand how to negotiate for new technology and processes demanded by Sponsors to ensure trial continuity in an uncertain environment.
    Dawn Pittinger, MBA, CHRC, CRCP, Clinical Research Consultant & Senior Account Manager, Bio-Optronics

    Workshop
         Budget, Contracts & Finance
         Business Development
         Site & Study Operations
         Technology

  • Summit Roundtable: NASH
    Kay Scroggins, President/CEO, Clinical Trials of TX
    Networking Opportunity
    Roundtable

  • October 16

    Friday EDT


  • Advanced eRegulatory Solutions for COVID-19 and Beyond (REG)
    Most sites are still utilizing paper, shared drives or other similar systems to organize, manage, and access research study documents. Site staff are already overwhelmed with conducting high-quality research with limited time and money to invest in process improvement. Further, the burden of work has become even heavier and more pressing during the COVID-19 pandemic. As a result, simple shared drives or similar document management systems can no longer provide the speed, efficiency or quality needed. The answer: Sites need to look beyond simple eRegulatory solutions and focus on “next-generation” document management platforms. This interactive panel will provide insight on how to select an innovation-driven solution that best meets sites’ needs.
    Rick Arlow, Founder & CEO, Complion
    Mandy White, MS, CCRP, Supervisor, Regulatory Affairs, Cook Children's Health Care System


    The Transition to Paperless Technology in Clinical Trials (OPS, TECH)
    As a result of Covid-19, the industry has rapidly adopted paperless systems to allow for electronic source, paperless regulatory site files, remote monitoring, virtual visits via decentralized trial portals, a faster transmission of data that eliminates the need for transcription and more. This webinar will explore the great benefits that these systems have brought to our industry in this challenging time as well as the opportunities this transition has presented. We will also openly discuss the long term impacts of these systems for sponsors, CROs and sites as we move into a completely paperless world.
    Rick Greenfield, BBA-IS, CEO, RealTime CTMS
    Nathan Levens, Director of Virtual Solutions & Technology, RealTime CTMS
    Workshop
         Regulatory & Compliance
         Site & Study Operations
         Technology

  • Summit Round Table: Rheumatology & Endocrinology
    Karri Venn, President, LMC Diabetes & Endocrinology
    Networking Opportunity
    Roundtable

  • October 21

    Wednesday EDT


  • The Trial of the Future: Fostering Diversity and Inclusion in Research (RR)
    Diversity in clinical research has become a key focus area throughout the industry. In addition to the need to build a more inclusive environment, diversity among participants is vital to ensuring the development of effective treatments. In this session, we’ll explore current efforts and best practices for fostering diversity within clinical trials and provide guidance to promote diverse recruitment across your organizations. We’ll focus on actionable steps you can take to improve recruitment and highlight how the shift to virtual and decentralized trials is the perfect time to focus on inclusive recruitment initiatives.
    Jivan Achreja , CTO and President, Solutions & Technology, Advarra


    Partnering with Clinical Research Sites to Improve the Patient Experience in Clinical Trials
    The purpose of the workshop is to explore strategies for sponsors to partner with sites to improve the patient experience in clinical trials using digital technology (apps, web platforms, clinical trial patient portals, etc.). Learnings from the workshop will enable the discovery of a balanced approach to enhance the patient experience between sponsor-driven technology and site-driven technology. These learnings will guide the design of technology platforms that patients find valuable and which compliment (and not interfere with) the technology currently in use by sites.
    Hassan Kadhim, Global Head Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations, Global Development Operations
    Joe Dustin, Head of Clinical Innovation, Bristol Myers Squibb
    Peter D. Stetson, MD, MA, Internist & Hospitalist, MSK
    Workshop
         Recruitment & Retention

  • Summit Roundtable: Vaccine
    Andrew Kimball, VP, Business Development, Meridian Clinical Research
    Networking Opportunity
    Roundtable


  • *Sites Only Session


    Moving at the Speed of Science
    The response to the COVID-19 pandemic has shown that exceptional efforts can dramatically accelerate the clinical development of vaccines. So, what will it take to evolve the clinical trials ecosystem to better serve all patients? How do we partner to ensure equity in clinical trial access and awareness? What is the future of digitization and decentralization in clinical development?
    Site Partnership Symposium

  • October 22

    Thursday EDT


  • Adapt, Survive Thrive: How the Clinical Research Workforce Rebuilds in a Post-Pandemic World (HR)
    To say that 2020 kicked off with a lot of changes would be a massive understatement. Sadly, many sites have closed. Those who survived and thrived adapted their site operations and workforce. Not only are increased pipelines and rising competition prevalent, but also some roles are being displaced due to related site and sponsor adjustments. Sites will need to balance the “COVID regulatory clean up” with a plan moving forward. How can you proactively address the industry shift while also navigating these pressures as efficiently as possible? Join our workshop to gain insights on how COVID-19 has forever changed the workforce and what steps you need to take moving forward.
    Molly Downhour, MHA BSN NEA-BC OCN CCRC, Executive Director Clinical Research, Medix
    Nicole Mills, MS-CRM, ACRP-CP, Director of Clinical Research, Medix

    Assessing the Realities of “Site Crunch” During the COVID-19 Pandemic At the center of the clinical research ecosystem, clinical trial sites have not been immune from the larger forces currently disrupting the healthcare industry—issues being exacerbated by COVID-19.

    Over the last 7 months, we have seen increasing pressures being placed on sites due to the pandemic, a problem we are calling “site crunch.” As we continue to move forward together, the question must be asked of all stakeholders in the ecosystem, “How can we help our sites adjust to this ‘new normal’ as they look to conduct research trials going forward?

    Looking back to 2015, we have seen a sharp decline in sites and investigators choosing to participate in clinical research, while sponsor pipelines and clinical trial starts have exponentially risen. Fast forward to 2020, clinical trial sites are being asked to do more with less due to widespread staffing shortages caused by the pandemic. With trials increasing in complexity each year, clinical research sites are experiencing significant “crunch,” and we must anticipate the ways in which we can help our sites grow as their research pipelines grow.
    Molly Hair, Director of Site Engagement and Management, WCG ThreeWire
    Seth Nelson, Vice President of Clinical Strategic Solutions and New Product Development at WCG ThreeWire
    Workshop
         Human Resources & Legal

**All times are Eastern Daylight Time**


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