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Running decentralized trials at scale

There's been a rapid shift towards decentralization in clinical trials and it's clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, and direct-to-patient supply are virtual tools that existed before the pandemic. But now there's swift adoption of these methods because they've been proven to help launch and complete trials more effectively.

Yet it's important to note that there's a significant learning curve for sponsors as these new methods graduate from early-phase into larger pivotal trials that must prove efficacy. There are pitfalls to avoid and key elements to keep front and center. Most trials won't be fully virtual, but all trials will be more virtual. In this Endpoints News webinar, we've assembled a panel of clinical experts who are running the trials of tomorrow, today. We'll look at:

  • Which therapeutic areas are ripe for highly decentralized trials? Which areas will be least resistant to this kind of change?
  • What's the experience of sponsors deploying decentralized elements at scale in late-stage trials?
  • What are the challenges in supplying drug products for late-stage decentralized trials?
  • How should sponsors be thinking about validating remote data?
  • What are some of the most effective technological solutions to accelerate trial deployment?
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Nicole Gray

Nicole Gray

Director, Strategic Supply Solutions, Catalent Clinical Supply Services

Nicole Gray is Director, Strategic Supply Solutions for Catalent Clinical Supply Services and is responsible for developing the Direct to Patient business and other new strategic service offerings. Ms. Gray has been in the Pharmaceutical industry for the past 18 years and has held multiple roles in clinical supplies project management. Prior to moving to her current role in August 2018, she spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers and Senior Project Managers. Prior to moving to Catalent Philadelphia, Ms. Gray was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, she held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance and the United States House of Representatives.

Ms. Gray is an active member of the Global Clinical Supplies Group. She is the Vice Chair for the 2022 US Conference and previously held both the U.S. Conference Secretary and Board Secretary roles.

Alison Holland

Alison Holland

Head of Virtual Clinical Trials, Medable

Alison Holland is the head of virtual clinical trials at Medable. She has more than 30 years of clinical trial experience, most recently as Global VP & General Manager for General Medicine at Covance, a leading global clinical research organization. Holland has managed more than 300 clinical trials, working successfully with biotech organizations as well as global pharma on some of their most critical initiatives. She can be reached at alison.holland@medable.com.

Arsalan Arif
moderator

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.