Analysis

Our scientific team understand the requirements for robust qualitative and mixed methods analysis in an increasingly demanding patient-focused regulatory landscape. We partner with you through every step of the process to deliver compelling evidence to support regulatory submissions and commercial decision-making.

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Patient evidence for robust regulatory submissions

Regulators have fundamentally shifted their expectations for evidence—patient experience data has evolved from a "nice-to-have" to a component routinely recommended by regulators. Our approach to analysis has evolved in line with regulatory requirements for PFDD, so all aspects of the study design, analysis, and reporting are conducted in accordance with FDA guidance.

Based on your research objectives, CLINIGMA^® can provide robust patient evidence to strengthen your regulatory submissions. Our scientific team will partner with you to transform complex patient experience data into compelling regulatory evidence—through systematic coding, content, thematic and mixed-methods analysis, and other FDA-recommended methodologies.

Depending on your commercial and regulatory goals, our experienced team can deliver robust findings to support clinical endpoints, labelling claims, and data to demonstrate meaningful treatment benefits. Whether you're analyzing quality of life outcomes or caregiver burden, our team of dedicated analysts provide the expertise and rigor to convert your patient feedback into powerful evidence for patient-informed regulatory outcomes and market differentiation.

Methodological rigor

Our systematic coding frameworks and iterative analysis ensure consistent interpretation across all data sources, with multiple CLINIGMA^® analysts independently reviewing data to minimize bias.

Theoretical grounding

At CLINIGMA^®, we anchor our analysis in established theoretical frameworks (content analysis, thematic analysis, descriptive analysis) while remaining open to emergent themes, creating a balance between structured inquiry and inductive discovery.

Comprehesivenss

Our team designs studies to achieve data saturation even among sub-groups, ensuring diverse patient perspectives are captured, analyzed and adequately represented in findings and reports.

Integration and synthesis

We transform individual accounts into overarching findings while revealing patterns, contradictions, and nuances across the entire dataset, providing actionable intelligence for your decision-making.

Social and cultural sensitivity

At CLINIGMA^® we value diversity and our inclusive ethos shapes how we conduct analysis. We consider the broader context of participants' lives, including cultural, social, economic, gender, and age-related factors that may influence people's experiences and opinions.

Transparency and auditability

CLINIGMA^®'s clear documentation of analytical decisions, coding rationales, and thematic development creates an audit trail that demonstrates the credibility and trustworthiness of our results.

Partner with CLINIGMA^®

Transform your clinical trials with the power of patient voices. Our innovative approaches combine scientific rigor with industry expertise, delivering:

Detailed analysis plans developed early and aligned with client objectives

Collaborative research outputs tailored to client needs and priorities

Deep and meaningful understandings of patient experiences

Enhanced regulatory compliance

More effective drug development processes

Patient-informed regulatory outcomes

AI-powered research: find out how we are using AI and automation to enhance consistency, traceability, depth and speed in the analysis of large data sets.

We bring our clients closer to patients

CLINIGMA^® Explorer is an immersive tool for clients to better understand insights as they emerge. Whether you are interested in disease burden, treatment expectations or experiences, CLINIGMA^® Explorer will help you understand patterns in the data.

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