IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Standards Association (IEEE SA) today announced the launch of an IEEE Industry Connections activity entitled Technology and Data Harmonization for Enabling Remote Clinical Trials. As a first step, an assimilated forum will be established for evaluating and testing the best methods to achieve data outputs and capabilities supporting clinical trials, which will require extensive process changes in order to evolve into the digital era.
Technologies, such as artificial intelligence (AI), blockchain and distributed ledger technologies (DLT), the Internet of Things (IoT), sensors and virtual and augmented reality (VR/AR), in combination with current technology systems, will be explored for improving remote clinical trials, from patient recruitment through to FDA submission.
“The estimated $44.2 billion global clinical trials market is facing a number of challenges related to patient recruitment and retention, rising costs to meet regulatory policies, data governance, and more,” said Tory Cenaj, chair, IEEE Technology and Data Harmonization for Enabling Remote Clinical Trials. “This important project establishes a framework for vastly improving how remote patient clinical trials are conducted by leveraging new technologies to significantly reduce the time and cost of bringing life-saving medicines to market.”
Participants in the IEEE Technology and Data Harmonization for Enabling Remote Clinical Trials initiative will develop a consensus-driven workflow that will later be tested against a simulated clinical trial to prove the following outcomes:
- A more efficient and inclusive patient recruitment and engagement process.
- Restored data integrity and validation, requiring fewer resources for audit and submission for approval.
- Ability to enable one original and immutable patient log from informed consent through the publication of trial results.
- Reduction in cost and time for securing and establishing sites, patient recruitment and retention, quality control and audit of data.
Maria Palombini, director, Communities & Initiatives Development Emerging Technology, IEEE SA, will moderate the panel discussion and 1 hour workshop Tech & Data Harmonization for Enabling Remote Clinical Trials at the upcoming ConVerge2Xcelerate (#ConV2X) health-technology conference to be held 15 October 2019 at the Seaport World Trade Center in Boston, MA. Panelists include:
- Ben Chevallereau, Senior Architect, Synchrogenix, a Certara Company
- Basker Gummadi, Clinical Digital Innovation, Celgene
- Rajesh Jain, Co-Founder & Principal Solution Architect, Consilx
- Jim Nasr, Vice President, Technology & Innovation, Synchrogenix, a Certara company
- Mathew Rose, Founder, Saavha
- Chris Watson, Ph.D., Director of Product Strategy, ERT
Learn more about the benefits of IEEE Technology and Data Harmonization for Enabling Remote Clinical Trials and how to participate today.
About the IEEE Standards Association
The IEEE Standards Association, a globally recognized standards-setting body within IEEE, develops consensus standards through an open process that engages industry and brings together a broad stakeholder community. IEEE standards set specifications and best practices based on current scientific and technological knowledge. The IEEE SA has a portfolio of over 1,250 active standards and more than 700 standards under development. For more information visit http://standards.ieee.org.
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