CLINIGMA

🏆 CLINIGMA® has been awarded the title of Leaders in Patient-Centric Clinical Innovation 2026 in the Healthcare & Pharmaceutical Awards by Global Health & Pharma The award recognizes the CLINIGMA® Portal, the system we built to run in-trial patient interviews to full ICH-GCP standards. From controlled access and a full audit trail to rapid escalation of any patient safety concern, it makes sure patient interviews meet the same standard as every other part of the trial. Above all, it is a recognition of the entire CLINIGMA team. From our operational teams coordinating and delivering interviews every day across 35+ countries, to our researchers designing, conducting, analyzing and reporting the interviews, and our technology teams building and running the CLINIGMA Portal — every part of our organization contributes to making this possible. It is this combination of scientific expertise, operational excellence and technology — and the dedication of our people behind it — that enables us to capture the patient voice reliably across global clinical trials. This award belongs to all of them. Read the full feature with our Founder and CEO Jens Harald Kongsø in the Q3 2026 issue (page 10): https://lnkd.in/eGVa3m36 #PatientVoice #ClinicalTrials #PatientCentricity

When pharma companies organise clinical trial results meetings, they may want to discuss the clinical outcomes with the investigators. 💬 The intention is good. Investigators are often among the first to test the new molecule on patients, and their observations can be important in informing drug development. One of the challenges is that the results meetings often take place up to five months after the Key Result Meeting. Can you remember clearly what you experienced five months ago? Can they? 📝 We are sharing a new CLINIGMA paper highlighting seven challenges of using clinical trial results meetings to get the investigators' observations. Importantly, we present a much easier and better way to listen to the investigators and study nurses. We hope you enjoy the read. 🔗 Read the full insight here: https://lnkd.in/eMVnnZ7M

🗓️ Our next webinar is on 16 September: A Practical Guide to Conducting In-Trial Patient Interviews This is part 2 of our four-part series. The first session covered compliance and what to expect from a provider. This one is operational, from the sponsor's side. Jens Harald Kongsø, Julie Perch and Linda Nelsen will walk through embedding interviews in the trial protocol, timing them around the trial without adding work for sites, building an interview guide that fits the objectives, keeping the documentation in order, and what archiving requires in practice. 🎓 Attendees also get access to our learning module: videos to watch, then a test at the end, with a certificate of completion once you pass it. 👉 Register here on Xtalks: https://lnkd.in/eRX4--Bp All the details are in the new issue of The Patient Voice.

We are delighted to welcome Linda Abetz-Webb to CLINIGMA as our newest Scientific Lead! 🎉 Linda joins us as an external contractor while continuing to run her own consultancy, P-COA. Internationally recognised for her expertise in patient-centred outcomes research, particularly in paediatrics and rare diseases, Linda brings decades of experience designing and delivering qualitative research, including in-trial interviews and clinical outcome assessment strategies that generate high-quality evidence to support drug development, regulatory decision-making, and market access. Linda joins Louise Newton, our Chief Scientific Officer, and Linda Nelsen as part of CLINIGMA's scientific leadership team, further strengthening our expertise and our commitment to delivering scientifically rigorous in-trial interview research. A warm welcome to Linda! #ScientificLeadership #PatientCentredOutcomes #RareDiseases #PaediatricsResearch #QualitativeResearch #ClinicalOutcomeAssessment #DrugDevelopment #RegulatoryAffairs #MarketAccess

🎥 The 20th video in the series: Training sites for in-trial interview success Compliance is ultimately the pharmaceutical company's responsibility, which means all personnel involved in in-trial interviews must be adequately trained. In this video, Rosa Weber, Senior Trial Manager, discusses why clinical site training matters and the key areas sites need to be trained on. Stay tuned—our next videos will continue guiding you through the essential steps of conducting in-trial patient interviews. 👉 Watch Video 20 to understand site training requirements for interview studies. #ClinicalTrials #PatientCentricity #ClinicalDevelopment #Pharma #DrugDevelopment #RegulatoryAffairs #PatientInsights #ClinicalResearch #PatientInterviews #ICHGCP #SiteTraining #Compliance

CLINIGMA webinar, "Plan Patient Interviews to Strengthen Trial Data Readiness," is now available here: https://lnkd.in/dXqWbSKN In the session, Jens Harald Kongsø and Christian Holm walk through why in-trial interviews are increasingly treated as GCP data, who stays accountable once the work is delegated to a vendor, and the compliance gaps that show up in real projects. 📄 You can also download our free RFP template here: https://lnkd.in/d9Hcd2kG. It is built to help you set clear requirements for your in-trial interview provider before you sign, rather than after a regulatory inspection. 🗓️ This was part one of several. Where this first session focused on planning and what to require before you sign, the next one turns to the operational side, what it actually takes to conduct in-trial interviews within a live trial. It is planned for September, so follow us here on LinkedIn to catch it when it goes live. You can also sign up at the below link and get free access to the recording. 💬 Have a question from the session? Drop it in the comments or reach out to us directly. We are always glad to talk it through. #ClinicalTrials #ClinicalResearch #PatientCentricity #GCP #PatientVoice #DrugDevelopment #ClinicalOperations #RegulatoryCompliance #PatientExperience