May 17-18, 2021
Online Livestream
Trials
4th VirtualClinical Trials
Days
Hours
Minutes
Seconds
A year ago, virtual clinical trials were a high-interest curiosity; now, they are essential to your pipeline. COVID-19 has forced more trials to be conducted virtually, and this has the potential to reveal new innovations and improve the patient experience. But how can we ensure this new age of decentralized trials will bring lasting benefits to clinicians, sponsors, and patients, while also accelerating time-to-market?

Switching to virtual trials requires more than just running standard methods in front of a webcam. Your entire clinical approach must be reconceptualized in order to get the most benefit from a virtual approach. Lack of industry-wide standards is the biggest barrier to collecting and leveraging patient data; each pharma company or vendor may have their own set of systems or safety tools, and integrating these can be a huge obstacle for your pipeline.

You cannot afford to miss the 4th Virtual Clinical Trials conference – the industry’s leading, longest-lasting conference on this subject, offering you exclusive insights our speaking faculty hasn’t shared anywhere else!
Top Reasons to Attend
  • A roadmap for turning urgent responses to COVID into permanent new processes that will keep your momentum going
  • Best practice on updating SOPs for these unprecedented problems
  • Strategies to maintain patient centricity, safety and feedback throughout the trial
  • Up-to-date review of new assessments and expectations from regulators
  • Key techniques for collaborating around new data standards with service providers
Who Should Attend
  • Patient Recruitment
  • Remote Monitoring
  • Trial Design
  • Decentralized Trials
  • Virtual Trials
  • Clinical Trials
  • Patient Experience
  • Patient Solutions
  • Clinical Projects
  • Clinical Projects
  • Clinical Data
  • Clinical Trial Operations
  • Clinical Supply Chain
  • Clinical Processes
  • Clinical Systems
  • Scientific Affairs
  • Digital Health
  • Clinical Trial Manager
  • Clinical Trial Supply Management / CTSM
  • Digital Engagement
  • Quality Planning
  • IT Business Partner
  • Principal Scientist
  • Site Manager
  • Strategy and Innovation
  • Procurement Manager
  • Program Manager
  • Project Manager
  • Regulatory Affairs
  • Business Development
  • Clinical Affairs
  • Clinical Development
  • CQA Auditor
  • Clinical Project Scientist
  • Medical Affairs
  • Medical Advisors
  • Clinical Safety
  • Clinical Data Management
  • Clinical Regulatory Affairs
  • Operational Strategy
  • Outsourcing
  • R&D
  • Site Solutions
  • Data Manager
  • Chief Technology Officer
  • Chief Digital Officer
  • Digital Strategy
  • Clinical Sciences / Clinical Scientific Affairs
  • Clinical Research Associate / CRA
  • Clinical Research
  • Clinical Technology
Conference
New Topics
Featured Speakers
Amy Leitman
NTM INFORMATION AND RESEARCH
Patient Advocate
Angel Soubhie
BAYER
Head Clinical Trial Scientists - Medical Director
Antonieta Sosa
Janssen
Director, Clinical Innovation
Barney Morris
Patient Advocate
Craig Lipset
CLINICAL INNOVATION PARTNERS
Founder
Daniella Hensley
JANSSEN
Director, Global Clinical Operations
Dave Bjork
Research Evangelist
Patient Advocate, CEO
Deborah Collyar
Patient Advocates In Research (PAIR)
Patient Advocate, CEO
Dimitri Talantov
JANSSEN
Sr. Director Medical Affairs Clinical Trial Innovation
Elizabeth George
GLAXOSMITHKLINE
Director, Clinical Trial Diversity
Gary Friedman
PFIZER
Director, Immunology and Autoimmunity
Jane Myles
COVANCE by LABCORP
Director, Decentralized Trials Implementation
Jen Horonjeff
SAVVY COOPERTIVE
Patient Advocate, Founder and CEO
Jeremy Price
PFIZER
Director, Clinical Operations Strategic Partnerships
John Reites
THREAD
CEO
Karlin Schroeder
PARKINSON’S FOUNDATION
Associate Vice President, Community Engagement
Lise Sylvest Helledi
NOVO NORDISK
Senior Project Manager, Clinical Development
Maggie Sweeney
VERTEX PHARMACEUTICALS
Associate Director, Quality Oversight of Clinical Programs
Maimah Karmo
TIGERLILY FOUNDATION
Patient Advocate, CEO
Michelle Luo
TAKEDA
Head of Global Evidence & Outcomes
Michelle Shogren
BAYER PHARMACEUTICALS
Senior Director of Innovation, Pharma R&D Clinical Operations
Nancy Li
BAYER
Global Category Lead - Central & Core Labs
Noolie Gregory
SYNEOS HEALTH
VP, Operations Management, Decentralized Solutions Team
Peter Schaeffer
GLAXOSMITHKLINE
Projects, Clinical Platforms and Sciences Third Party Resourcing Analytics Director
Ray Doresy
UNIVERSITY OF ROCHESTER CENTER for HEALTH AND TECHNOLOGY
Director
Robin Marcus
COVANCE by LABCORP
Head of DCT Market Development, DCT Center of Excellence
Rosamund Round
PAREXEL
Vice President, Patient Innovation Center and Decentralized Clinical Trials
Safwan Kezbor
SHIONOGI
Medical Director, Clinical Development
Stephen Lutsch
LEO PHARMA
Director, Head of Revolutionize Clinical Trials
Vinod Das
BAYER
Associate Director for Pharmacovigilance
Wendy Wu
JAZZ PHARMACEUTICALS
Director, Clinical Development
Event Schedule
ALL TIMES ARE IN EASTERN STANDARD TIME

If this pandemic has taught us anything it’s that the future is now – so what are you going to do about it?  Deep dive into where we are headed and where new goals should aim. 

  • Example of innovation applied to advance clinical trials from those on the front lines
  • Utilize novel digital tools for better recruitment and retention
  • Discover the pivots in the protocol plans that propelled the success of future trials
  • Discuss innovative ways to keep momentum of the positive exposure to decentralized trials and drive towards other medical areas outside of COVID 19

Explore remote collection of Glycaemic and Behaviometric data among patients with Type 2 diabetes Mellitus. Hear about the challenges and future prospective of the study,

  • Explore study design and data collection via e-devices
  • Operational considerations
  • Discuss the patient perspective

The sponsor can document protocol deviations using its standard processes, or use alternative documentation approaches. What sort of infrastructure is needed to support decentralized trials?

  • Develop a concrete plan and update your SOPs or guidelines
  • Focus on what working practices are today and how are they differ from a year ago  
  • Introduce permanent procedures to capture documentation 

Delivery of mobile clinical services (e.g. mobile nursing, home biologic sample collections, training on equipment use and protocol compliance) depends on smooth coordination between the sponsor, CRO, sites, central lab, and the mobile clinicians. The old paradigm of using paper for source data collection comes with many inherent problems; switching to a fully-digital workflow addresses these issues while also improving study efficiency and promoting tighter connections between the stakeholders.

  • PIs are able to easily order and monitor the conduct of mobile clinical visits,
  • There can be a transparent view to the services ordered, the status of the orders, all via a unified dashboard
  • A unified solution based on an integrative technology platform is essential for providing high touch care which enhances the patient experience
The technologies pioneered for decentralized trials can greatly increase your efficiency and lead to expedited drug development. In particular, deploying share portals can increase patient recruitment, retention, and engagement, which in turn benefits trial accuracy.
 
• Avoid trial slowdowns by training personnel on systems that cover multiple technologies rather than per each technology
• Create user ability efficiencies to avoid the exclusion of patients who are not tech savvy or who may not possess the needed devices
• Utilize patient software

Why are companies slow to adopt decentralized trials? Review the current situation with the pandemic and see how these trials can lead to more diverse and patient-centered trials.  Increase patient diversity in trials Tackle recruitment and retention in trials head-on Explore opportunities to reduce the burden on patients

Vendor management, auditing and scalability are key concerns in an evolving clinical trial landscape. Assessing vendor availability and operational continuity, particularly regarding data collection, patient recruitment, and enrollment, is essential for planning out your safety monitoring procedures.
 
• Find new ways to develop standards for patient-facing technology
• Retain patients through the right platform and be more patient-centric
• Ensure vendors are both flexible and customizable to the needs of each patient and trial design
ALL TIMES ARE IN EASTERN STANDARD TIME

Decentralized trials may potentially unlock new advantages in quality, recruitment, and retention – but are you set up to bring these processes to operational life?  You could access patients that were previously unable to participate in clinical trials, if only you establish and test the best processes.

  • Identify what procedures can be implemented at home
  • Ease travel burdens for patients and improve engagement of local clinical facilities to conduct activities
  • Understand the laws and regulations that allow and don’t allow DCT in various locations

If all stakeholders can agree on the new best standards, you can be poised to reduce both the time and cost of clinical trials, as well as improving patient outcomes and QOL.  But are you set up to gather and act on all the feedback you need?  

  • Discover invaluable benefits of increased collaboration and data sharing among the scientific community
  • Explore collaboration efforts to ensure quality at the investigational site level and quality within the trial with sponsor
  • Understand how FDA and EMA watch, influence and contribute to collaboration  

Decentralized clinical trials can improve safety monitoring and patient follow up. How can we make sure these new efficiencies are available for the patient’s access? 

  • Importance of communication in the trial
  • Design the trial with the language of the protocols
  • Ensure not to sacrifice quality along the way
  • Explore case studies and key learnings from rapid DCT adoption over the past year
  • Share direct feedback from patients and physicians from underrepresented communities on how to enhance DCT access and optimize the trial experience
  • Highlight exciting innovations that will facilitate continued evolution of the DCT model

Personalization Approach to Obtain Accurate Assessments of Patients with Limited Face to Face Interaction

The effect of decentralized trials on the patient experience is both positive & negative.  How do DCTs help the trial get a clearer picture by seeing the patient in their own environment? 

  • Provide a personalization approach to enhance participant experience
  • Analyze the new variables introduced by multiple patient settings
  • Utilize patient advocates properly to enhance your studies
With the increasing use of telemedicine in clinical practice, training and procedures must be
adapted from a regulatory perspective. Many important steps of trial visits can and have
been transitioned into video conferencing.
  • Explore effective strategies to conduct real-time video use of telemedicine for remote clinical trial visits
  • Understand how role of digital biomarkers in these studies
  • Learn about ongoing decentralized research studies

Conceptually, an ideal endpoint should be a valid and applicable measure of how a patient feels, functions or survives and be perceived by end-users of the research as having meaning and value. It is a responsibility of those who design and conduct trials to choose endpoints which will influence decision-making by clinicians and policymakers.

  • Discuss the tools that will be used for endpoint measurement
  • Cover mobile technologies to collect endpoints in decentralized trials 
  • Use patient engagement  to define meaningful change, select endpoints and develop/select PROs
Register Now

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