René is a qualitative research specialist with over a decade of experience investigating the human dimensions of health and healthcare. At CLINIGMA®, she plays a central role in in-trial patient interview analysis for global pharmaceutical clients, delivering regulatory-aligned insights grounded in real-world treatment experience. With a PhD in Public Health and Policy from the London School of Hygiene and Tropical Medicine, René brings interdisciplinary expertise across anthropology, health systems, and pharmaceutical policy to support patient-focused drug development.

Qualitative and Public Health Research

·       Experienced in conducting and analysing in-trial patient interviews using ethnographic and thematic methods, including semi-structured interviews and participant observation

·       Skilled in translating patient narratives into structured insights that support label claims, product development, and global regulatory submissions

·       Supports development of coding frameworks, inter-coder reliability processes, and integrated synthesis across diverse patient experiences

·       Holds a PhD in Public Health and Policy (LSHTM) and a Master’s in Social Anthropology, with a research focus on antimicrobial resistance, drug-resistant TB, and healthcare access

·       Experienced in aligning qualitative analysis with FDA Patient-Focused Drug Development (PFDD) and EMA frameworks, ensuring deliverables meet expectations for clarity, traceability, and scientific rigour

Sponsor Collaboration and Regulatory Alignment

·       Experienced in cross-functional collaboration with sponsors, medical writers, and regulatory teams to ensure timely, actionable outputs

·       Skilled at presenting qualitative findings in ways that meet the evidentiary standards of FDA, EMA, and HTA bodies

·       Contributes to preparation of final reports, study appendices, and patient experience narratives for submission packages

·       Familiar with ICH-GCP and ethical considerations in trial-based qualitative research

Global Insight and Cultural Competency

·       Extensive fieldwork in South Africa

·       Expertise in the structural, social, and behavioural factors influencing treatment access and adherence

·       Supports global sponsors in generating culturally grounded, patient-focused evidence for regulatory submissions and market access

René brings a blend of qualitative depth, global health expertise, and interdisciplinary training to every project. Her ability to uncover the human story behind treatment data helps pharmaceutical clients translate patient voices into meaningful, evidence-based strategies for development and regulatory success.