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.
Speakers
Jens Harald Kongsø, MSc in Economics, Founder and CEO, CLINIGMA®
Jen has 20 years of experience in Health Economics and Market Access at global pharmaceutical companies, supporting drug development from early stage through launch. With extensive experience in patient reported outcomes across clinical trials, he founded CLINIGMA on the belief that statistical results alone cannot fully reflect what patients actually experience and value.
As CTO of CLINIGMA, Christian leads the technology infrastructure that enables ICH-GCP compliant in-trial patient interviews at global scale. He has deep expertise in clinical trial technology, data privacy regulations including GDPR, HIPAA and ISO 27001, and international compliance frameworks, ensuring patient interview data is captured securely and remains auditable across jurisdictions.
Message Presenter
Christian Holm, MSc in Computer Engineering, CTO and Country Manager, CLINIGMA®
Christian brings years of specialized expertise in Clinical Trial Technology and Software Engineering to CLINIGMA®. As Chief Technical Officer, Country Manager and Member of the Board, he leverages his deep-rooted expertise in patient interview methodologies and regulatory compliance to drive technological innovation while ensuring the highest standards of data privacy and security.
Message PresenterWho Should Attend?
This webinar will appeal to professionals involved in:
- Patient Insights
- HEOR
- Market Access
- Medical Affairs
- Clinical Development
- Patient Engagement
- RWE
- Outcomes Research
- Patient Advocacy
What You Will Learn
Attendees will gain insights into:
- How FDA and EMA guidance promote more patient-focused drug development. What does that mean in practice for sponsors considering in-trial interviews?
- How recent ICH-GCP E6(R3) updates have raised the bar for how interview data must be planned, collected and protected
- What patient safety and data integrity mean at the planning stage, and the decisions needed before interviews begin
- How an RFP template and checklist help evaluate in-trial patient interview vendor proposals
Xtalks Partner
CLINIGMA
CLINIGMA® specializes in in-trial patient interviews, capturing the patient voice at every stage of drug development, so that what patients actually experience and value informs regulatory submissions, labelling claims, and commercial decision-making.
We conduct interviews anywhere in the world, with active operations across 35+ countries and a global network of 300+ Master’s and PhD-level researchers. All interviews are conducted in full compliance with ICH-GCP, translating authentic patient insights into regulatory-grade evidence.
We manage the entire interview process, from planning to reporting, through our own interview platform. The CLINIGMA® Portal is the first system purpose-built to securely capture patients’ own words in real time, with full compliance with ICH-GCP and global data protection standards. Alongside it, we have built CLINIGMA® Explorer. It complements the final report by allowing transcripts to be filtered, searched, and compared as they arrive, giving teams a head start on understanding what matters most to patients.
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