Register today to attend Clinical Trials Digital Week, our free-to-attend webinar series featuring critical updates related to Partnerships, Outsourcing, Operations, Technology and Decentralized Clinical Trials. To learn about sponsorship of future events, contact partners@informaconnectls.com

DAY 1 – JUNE 7, 2021



Fueling Digital Health with Decentralized Clinical Trials
9am EDT / 2pm BST / 3pm CEST

Discussion points

  • Regulatory pathway supporting digital health technology-driven DCTs
  • Digital enterprise architecture leading the modernization of trials
  • Transformative experience for participants and their health journey
  • Equity and inclusion of diverse populations by breaking geographic barriers and proactively planning DCTs
  • Unique interception of DCTs, CRAACO, digital health technologies, and standard healthcare
  • Future directions of DCTs and digital health technologies

Speaker:

Isaac R. Rodriguez-Chavez, Ph.D., M.H.S., M.S.
Senior Vice President for Scientific & Clinical Affairs
PRA Health Sciences

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Decentralized Clinical Trials Have Arrived: Amplify Science with Patient-Centered Design and Experience
10am EDT / 3pm BST / 4pm CEST

Medable has reached its 100th trial, signaling a new era in clinical trials, one that democratizes patient access by removing the barriers posed by geography. Today’s trials offer sponsors and CROs new opportunities to improve time to treatment and realize operational efficiencies across R&D using a new set of unified patient-focused digital approaches.

However, how sponsors choose to deploy these tools is key in realizing efficiencies.

Join Medable’s Executive DCT GM Ali Holland, Digital Endpoint GM Gillian Livock, and Chief Design Officer Sina Mossayeb as they share lessons learned and best practices from their time spent modernizing trials with flexible, modular, and seamless decentralized solutions. Attendees will walk away with an understanding of:

  • Best practices for future trial design,
  • Lessons learned over the course of 100+ decentralized trials across 1M patients, and
  • How to create a design state for our end-users, in order to improve the experience for all and increase adoption

Speaker:

Tyler Pugsley
VP of Life Sciences
Medable

Gillian Livock
Digital Endpoint GM
Medable

Sina Mossayeb
Chief Design Officer
Medable

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Collaboration to Accelerate Global Adoption in Decentralized Trials
11am EDT / 4pm BST / 5pm CEST

  • Highlight the challenges in DCT scale that may best be addressed through collaboration
  • Review the goals and progress of the Decentralized Trials & Research Alliance to support global adoption
  • Describe a future-state enabled through collaboration

Speaker:

Craig Lipset
Founder & Advisor, Clinical Innovation Partners, Co-Chair
Decentralized Trials & Research Alliance (DTRA)

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DAY 2 – JUNE 8, 2021



Scaling Decentralized Clinical Trials: Best Practices and Lessons Learned to Strengthen Patient-centricity and Global Trial Delivery
9am EDT / 2pm BST / 3pm CEST

Not only are decentralized clinical trials (DCTs) one of the biggest buzzwords in the industry, they are becoming the new normal for clinical trials. As businesses prepare to adopt DCTs at scale, they must capitalize upon the operational process improvements and technology advancements made in the last year.

In this session, IQVIA leaders will share case studies and insights gleaned from designing and delivering more than 65 decentralized trials – small and large, local and global.

Speaker:

Melissa Easy
Vice President, Research & Development Technologies
IQVIA

Patricia Salter
Senior Director of Operational Transformation and Performance, Research & Development Solutions
IQVIA

Chuck Drucker
Head of Decentralized Trials Solutions
Q2 Solutions

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Decentralized Research: Does Decentralized Fit Your Protocol & Evidence Generation Goals?
10am EDT / 3pm BST / 4pm CEST

  • Explore a framework for virtual and decentralized evidence generation strategies
  • Considerations for determining whether you can incorporate decentralized study elements
  • The intersection between technology and practical decentralized protocol design
  • Optimizing data acquisition in DCTs with patient mediated medical record release and healthcare data interoperability
  • Direct to patient recruitment strategies

Speaker:

Jersino Jean-Mary
Executive Director, European Late Stage Operations
UBC

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Decentralised Trials in a Post COVID World – Hype meets Reality
11am EDT / 4pm BST / 5pm CEST

  • How decentralised trials can improve patient experience and reduce burden
  • The opportunities to increase diversity and inclusion
  • Ensuring that data quality isn’t compromised through delivery of decentralised trials
  • True transformation – opportunities for transforming the way we generate evidence and the difficult decisions this can require

Speaker:

Matthew Bonam
Head of BioPharmaceuticals R&D Digital Patient Health & Innovation
AstraZeneca R&D

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DAY 3 – JUNE 9, 2021



Clinical Trials a la mode: Modal Values and Intelligent Trial Design
9am EDT / 2pm BST/ 3pm CEST 

Clinical trials are most often designed from the bottom-up, i.e. based on the experience and expectations of the sponsor. Unfortunately, even experienced trialists must deal with avoidable protocol amendments, poor investigator selection, and overambitious timelines. Protocols and programs can be designed now based on both a bottom-up and top-down approach where the volume, variety, and velocity of the clinical trial universe provide an opportunity for advanced analytics across a range of diseases, patient populations, and geographies to suggest practical steps and smarter planning to avoid these pitfalls.

This session will explore:

  • What are modal values in clinical trials and how they can be applied in clinical trial design.
  • Examples of real-world trials and modal values
  • Overview of advanced analytics for curated, data-driven site selection and trial planning.

Speaker:

Paul Chew
Chief Medical Officer
Phesi

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The Impact of the COVID-19 Pandemic on Early Phase Clinical Trials
10am EDT / 3pm BST / 4pm CEST

The COVID-19 pandemic posed and still poses unprecedented challenges on all stages of clinical trials. Regulatory agencies published guidance on how to manage clinical trials, stating that priority was to be given to COVID-19 studies, slowing down and halting non-COVID-19 trials.

The pandemic has forced all stakeholders to think outside the box and beyond their comfort zone.

Both our Clinical Pharmacology Unit and Clinical Operations will give you an insight into how they handled this unforeseen situation. Hear why it is important to be flexible and learn quickly in order to be able to (re)start trials under implementation of a strict COVID-19 risk mitigation plan, and minimize viral spread and impact on safety or data quality.

Speakers:

Katrien Lemmens
Medical Director
SGS Health Science

Marthe Heylen
Senior Clinical Project Manager
SGS Health Science

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What has Happened to Outsourcing and Vendor Selection with the COVID-19 Restrictions
11am EDT / 4pm BST / 5pm CEST

  • More remote vendor selection
  • Electronic Trial Master Files
  • Selecting and qualifying CROs has to be done differently
  • More electronic tools

Speaker:

Nancy Meyerson-Hess
Consultant Clinical Research, Chief Compliance & Regulatory Officer
eMQT

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DAY 4 – JUNE 10, 2021



Increase Inclusivity and Reduce Costs with a Decentralized Clinical Trial Approach
9am EDT / 2pm BST / 3pm CEST

The ideal clinical trial is more inclusive, transparent and diverse. This ideal clinical trial is also more cost efficient. Utilizing a decentralized clinical trial approach can offer specific opportunities to achieve both ideals. In this presentation, John Reites, CEO, THREAD will provide global insights and guidance on improving participant inclusion in global clinical trials, while driving the understanding of how DCTs can reduce costs in parallel.

  • Attendees will gain the following insights:
  • Opportunities that decentralized clinical trial options offer to make studies more inclusive
  • How making studies more inclusive can lead to reducing clinical trial costs
  • What costs can realistically be reduced by conducting decentralized global studies versus site-based studies

Speaker:

John Reites
CEO
THREAD

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Out of the Clinic and into the Home - Examples and Insights from +35 successful DCTs
10am EDT / 3pm BST / 4pm CEST

ObvioHealth, a pioneering VRO (Virtual Research Organization) will share case studies and insider insights based on more than 35 fully virtual or hybrid studies conducted across 28 countries and 16 therapeutic areas. This webinar, peppered with examples of end-to-end decentralized trials, will walk you through the process- from study design and recruitment to outcomes measurement and remote patient monitoring. We will explain how a virtual site team can assist patients through each step of the decentralized journey and show how wearables and sensors can provide more accurate data.

Speaker:

Matty Culbreth-Notaro
Chief Operations Officer
ObvioHealth 

Leslie Pascaud
Chief Marketing Officer
ObvioHealth 

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CASE STUDY: Executing a Completely Decentralized, Randomised, Controlled Clinical Trial
11am EDT / 4pm BST / 5pm CEST

  • Considerations for developing a study design (i.e. drug supply, data sources, site/PI involvement)
  • Determining the patient journey for successful study set-up
  • Patient recruitment and enrolment strategies
  • Challenges and lessons learned

Speaker:

Simi Kaul
Director, Clinical Project Scientist
Janssen Scientific Affairs, LLC

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