Dassault Systèmes has presented the ENRICHMENT Playbook, the first global guide that uses virtual twins to transform clinical trials. Developed in collaboration with the United States Food and Drug Administration (FDA), this innovative manual redefines the way trials are designed and executed, enabling simulations with unprecedented precision.
The Impact of Virtual Twins in Medicine
The ENRICHMENT Playbook is based on the "in silico" approach, which uses computational simulations to recreate patient populations and evaluate clinical outcomes. This methodology offers a disruptive solution that not only reduces the need for testing in humans and animals, but also improves patient safety, accelerates regulatory processes, and strengthens regulatory compliance.
Additionally, the playbook provides practical, expert-reviewed strategies for validating the credibility of computational models in clinical trials, meeting the highest scientific and regulatory standards.
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A Collaborative Milestone
The ENRICHMENT Playbook is the result of five years of joint work between FDA regulators, scientists from the academic field, experts in clinical practice, and the medical device industry. This interdisciplinary synergy ensures that the guide is useful for both researchers and companies seeking to accelerate the introduction of innovative medical devices to the market.
Claire Biot, Vice President of Biological Sciences and Healthcare at Dassault Systèmes, noted: "The adoption of digital technologies is reaching a stage of maturity in the healthcare industry. With this guide, we reaffirm our commitment to collaborating with experts and using advanced technologies to transform healthcare".
A Change in Global Healthcare
The launch of the ENRICHMENT Playbook marks a turning point in the evolution of clinical trials. By enabling precise computational simulations, Dassault Systèmes not only optimizes trial efficiency, but also reinforces medical ethics by reducing reliance on traditional testing in humans and animals.
This breakthrough highlights the importance of virtual twins as fundamental tools for accelerating innovation in the medical device sector, improving patient experience, and ensuring faster access to safe and effective healthcare solutions.
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