• Date:  November 15th, 2023 – @1PM EDT
• Company: Astrix
• Presenter: James O’Keefe, Head, Clinical & Regulatory Consulting, Astrix

Overview:

As the healthcare industry pushes towards modernizing clinical trials, recent draft guidance from the FDA, ICH, and others aims to guide the industry in adopting decentralized clinical trials (DCT) and digital health technologies for remote data acquisition. These new approaches present a significant opportunity to transform the way clinical trials are conducted, with potential benefits for patients, site staff, sponsors, and CROs.

However, the draft guidance also reveals significant gaps that raise concerns and confusion among stakeholders regarding the application of these new methods. Understanding these gaps and effectively implementing new approaches are critical challenges the industry must address while adhering to regulatory requirements.

This webinar will provide valuable insights into:

• The FDA’s Decentralized Clinical Trials (DCT), Digital Health technologies for Remote Data Acquisition & ICH E6 (R3) draft guidance recommendations
• Opportunities presented by the guidance
• Challenges in implementation and gaps in the guidance
• Ways organizations can move forward implementing new approaches under the guidance