In this free webinar, gain insight into how FDA and EMA guidance promote more patient-focused drug development. The featured speakers will share what that means in practice for sponsors considering in-trial interviews. Attendees will learn how recent ICH-GCP E6(R3) updates have raised the bar for how interview data must be planned, collected and protected. The speakers will discuss what patient safety and data integrity mean at the planning stage, and the decisions needed before interviews begin. Attendees will gain insight into how an RFP template and checklist help evaluate in-trial patient interview vendor proposals.
, /PRNewswire/ — The FDA and EMA increasingly expect to see the patient voice incorporated into drug development. In-trial patient interviews are one of the most direct ways to capture it. But generating data that withstands regulatory scrutiny starts long before the first interview is conducted. This webinar explores how patient interviews can be planned from the outset to support regulatory expectations and produce usable clinical trial data.
Getting the planning right matters more than most teams realize. In accordance with the principles of ICH E6(R3), finalized in January 2025, trial patient interview recordings should be treated as source data. They are subject to the same standards of integrity, traceability and documentation as any other clinical trial data. At the same time, conducting trial patient interviews across countries means navigating local data privacy obligations in addition to GCP requirements. The decisions made at the planning stage determine whether trial data will be accepted.
This is the first in a four-part webinar series covering the full lifecycle of in-trial patient interviews. This opening session focuses on what to be mindful of when planning: what FDA and EMA guidance requires, what has changed with recent ICH-GCP updates and what patient safety and data integrity mean in practice before a single interview begins. The featured speakers will walk through the most common planning mistakes and what a structured, compliant approach looks like.
Attendees will leave with a free RFP template and RFP checklist to evaluate and select patient interview vendors against the right criteria from day one.
Register for this webinar to learn how patient interviews can be planned to support clinical trial data integrity, patient safety and regulatory expectations.
Join experts from CLINIGMA, Jens Harald Kongsø, MSc in Economics, Founder and CEO; and Christian Holm, MSc in Computer Engineering, CTO and Country Manager, for the live webinar on Monday, June 15, 2026, at 11am EDT (5pm CEST/EU-Central).
For more information, or to register for this event, visit Plan Patient Interviews to Strengthen Trial Data Readiness.
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