10 GHP Q3 2026 CLINIGMA® is the only clinical research organisation with a system built specifically to capture trial patients’ own words during clinical trials, in full ICH-GCP compliance. Working with pharmaceutical companies worldwide, it currently interviews trial patients in 35+ countries at every stage of drug development, giving patients a structured voice in the process. To understand the work behind this recognition, we spoke with Founder and CEO Jens Harald Kongsø. In-trial patient interviews capture how patients actually experience a treatment during the trial itself, in their own words. Done well, that evidence can support regulatory submissions, labelling claims, and commercial decision making. It is a way of bringing the patient’s perspective into decisions usually made on numbers alone. Jens Harald explained: “In-trial interviews were wisely encouraged by the regulatory bodies, led by the FDA’s Patient-Focused Drug Development initiatives, in particular in rare diseases. We now see pharmaceutical companies not only using trial patients’ feedback to help inform the regulatory bodies, but also using that firsthand feedback to optimise drug development within their own organisations. It is very rewarding to help pharma companies unlock the value of their new drugs and to help inform the regulatory bodies. It is just as fulfilling when we get a ‘thank you for listening to me’ from a trial patient.” The innovation behind this recognition is the CLINIGMA Portal. Under ICH-GCP, what a patient says in an in-trial interview is source data, so it must be managed to the same standard as the rest of the trial and stand up to inspection. That calls for a system built for the purpose: access is controlled, every action carries a full audit trail, and the data cannot be altered after the fact. It also protects patients: when an interviewer records a potential serious event affecting a patient’s safety, the system requires and timestamps the escalation to their investigator, as auditable proof the patient was protected under the protocol. Keeping interviews on time and tied to the trial matters, but the more important thing is that everything the Portal captures can be trusted as evidence when the authorities look. This is where much of the industry still falls short. Offering in-trial interviews is not the same as conducting them so they survive a GCP inspection. Contact details sit in spreadsheets emailed around, interviews are captured on consumer tools never validated for clinical use, and source recordings are deleted once a transcript exists, leaving no way to prove it was not altered. With AI making records easy to change, that gap only grows unless the data is retained in full as GCP source data. Such shortcuts risk data being rejected, reworked, or flagged during inspection. The Portal was built to close them and remains the only system of its kind. Rigor depends on people as much as systems. “Every interview methodology we use is designed to hold up to regulatory scrutiny,” Jens told us, “because rigorous data is what ultimately ensures the patient voice has impact.” In-trial interviews are the core of CLINIGMA’s business rather than one service among many, delivered by a scientific team with deep experience in qualitative patient research to ICH-GCP standards. “Behind every study is our global team of 300+ master’s and PhD-level researchers, covering 100+ natively spoken languages and trained in ICH-GCP and projectspecific requirements to ensure patient safety, ethics, and high-quality data collection.” The innovation continues with the CLINIGMA Explorer, giving pharmaceutical teams direct access to the interview transcripts rather than a final report alone. As patient-focused drug development guidance matures in the US and EU, these tools keep clients ahead of requirements rather than reacting. In an industry where data validation and AI dominate the conversation, Jens is clear on the latter: “Our position is that AI is a tool that supports our researchers, not a replacement for the human expertise that regulatory-grade qualitative research requires. This is in line with the regulatory bodies’ recommendations. We continue to explore how AI can support strong patient-centred research while we maintain rigorous human oversight, full ICH-GCP compliance, and data integrity.” Education is a priority too. CLINIGMA shares knowledge through conferences, webinars, a LinkedIn video series, a newsletter, and a free template library for clinical research professionals. Plenty of providers can conduct an interview. The harder task is doing it so the data holds up to ICH-GCP and local data privacy law, and that is what CLINIGMA specialises in, currently working in 35+ countries for most of the world’s largest pharmaceutical companies. For getting that right, and for the system that makes it possible, we are proud to recognise CLINIGMA® as Leaders in Patient-Centric Clinical Innovation 2026. Contact: Jens Harald Kongsø Company: CLINIGMA® Web Address: www.clinigma.com Leaders in Patient-Centric Clinical Innovation 2026 AIM-Mar26373
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