The FDA and EMA increasingly appreciate seeing how the patient voice has been incorporated to inform 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. There are many practical pitfalls, hurdles and dependencies, each of which can jeopardize the collection of the in-trial interviews if not done correctly. Additionally, there are also many requirements to live up to, in order to ensure that the patients’ safety is secured and that the interviews can be trusted when they are submitted to the regulatory bodies.
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 in-trial interviews: what the FDA and EMA guidance requires, what has changed with recent ICH-GCP guideline 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.
Message Presenter
Christian Holm, MSc in Computer Engineering, CTO and Country Manager, CLINIGMA®
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 PresenterWho Should Attend?
This webinar will appeal to professionals involved in:
- Patient Insights
- COA
- HEOR
- Market Access
- Medical Affairs
- Clinical Development
- Patient Engagement
- RWE
- Patient Centered Outcomes Research
- Patient Advocacy
What You Will Learn
Attendees will gain insights into:
- What to be mindful of when sponsors are considering in-trial interviews in their clinical trials
- 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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