In March 2020, at the height of the COVID-19 outbreak, the FDA issued a new guidance providing advice to pharmaceutical companies about how to run virtual clinical trials, not just for potential virus remedies but for any drug they are developing. But even before the virus forced mass quarantining, the FDA was urging drug developers to embrace modernized R&D technologies and protocols—including virtual clinical trials—to speed up development and improve the diversity of patients enrolled in their studies.

In a virtual clinical trial, patients forgo many site visits and instead use telephone conversations, videoconferencing, mobile apps, e-mail and social media to provide investigators with real-time data and information about their symptoms. Studies have shown that the number of recruited patients increases significantly when travel requirements are removed, and the drop-out rate in phase 3 trials can be reduced by as much as 40%.

This Fierce webinar will bring together executives with expertise in R&D and technology implementation to explain the potential benefits of virtual clinical trials, as well as the ins and outs of designing and running them. It will include representatives from companies that have completed virtual clinical trials successfully and can provide advice on what did and did not work.

Topics include:

* How the latest sensors, diagnostics and wearable technologies can be used to record symptoms and collect data in clinical trials.

* FDA rules and other regulations that apply to virtual clinical trials and how they affect trial design and recruitment.

* Best practices for implementing technology tools to guarantee security and protection of patient privacy.


Featured Speakers

Mr. Shuta Mitomo

Digital and Innovation Planning, CRO Business
CMIC Group

Mr. Shuta Mitomo has over 20 years of experience in clinical development. He managed many clinical trials as a project manager leading the global sponsors to develop their drugs in Japan successfully.
Shuta is currently responsible for implementing new technology in clinical trials at CMIC Group.

Dr. Rodrigo Garcia, MD, MS

Head of Clinical Innovation
EMD Serono/Merck KGaA

Dr. Rodrigo Garcia is the Head of Clinical Innovation at EMD Serono/Merck KGaA. In this role, Rodrigo and his group are responsible for transforming clinical trials operations by introducing innovative digitally and data enabled solutions to study teams with a patient-centric mindset.
Rodrigo is a physician and clinical operations leader with 16 years of experience in the pharmaceutical industry.

Bert Hartog

Senior Director, Janssen Clinical Innovation
Johnson & Johnson

Bert is an experienced Senior Director and Innovation Leader. He leads transformational innovation projects that have the goal to shape the future of clinical trial execution, and position Janssen as a role model in patient-centered clinical research. Bert is an industry expert in Global Clinical Operations and Digital Health. He graduated in Biomedicine and obtained a PhD in Medicine from Utrecht University. He worked in Clinical Operations-, QA- and IT-management before joining Janssen’s Clinical Innovation team in 2015. His main focus today is developing capabilities for digital health in clinical trials, including digital outcome measures and technologies for remote patient monitoring.

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