Interview Manual
Development
Our interview manuals are meticulously developed in partnership with clients to meet scientific objectives and elicit meaningful patient experience data that truly strengthen regulatory submissions and strategic decision-making.
Unlocking the power of patient narratives
Our interview manuals are comprehensive, semi-structured guides that standardize the process of conducting qualitative patient interviews—to capture authentic patient experiences and priorities regarding disease and treatment. We work closely with you to define clear objectives to inform interview manual development. CLINIGMA®'s interview manuals ensure consistent data collection, while maintaining the flexibility needed to have meaningful conversations and to delve deep into the patient experience.
We co-design interview manuals with you for deeper insights
Tailored approach
Every project has unique challenges and objectives. We collaborate closely with your team to:
Provide strategic guidance to clarify project objectives and priorities
Understand your product and clinical trial's unique requirements
Capture meaningful outcomes that matter to patients
Customize questions to align with your goals
Regulatory focused
Built for success in today's regulatory environment, CLINIGMA® interview manuals:
Align with current FDA, EMA, and other guidance
Integrate seamlessly with data analysis plans
Support robust Clinical Outcome Assessment (COA) measures
Enhance regulatory submissions with compelling patient insights
Robust evidence and insights
Our mixed-methods analysis transforms patient narratives into:
Patient-centered COA strategies
Deep understanding of treatment benefits
Compelling evidence for regulatory submission and label claims
Comprehensive roadmaps from early drug development to regulatory approval and marketing
Strategic implementation
CLINIGMA® supports your trial at every crucial stage with:
Entry interviews that establish baselines
Interim interviews to capture treatment experiences over time
Exit interviews that capture comprehensive outcomes
Comprehensive design
CLINIGMA® interview manuals are comprehensive research tools that include:
Detailed interview protocols and project descriptions
Strategic closed- and open-ended questions and follow-up probes
Prompts that encourage patients to share their stories in their own words
Expert design to minimize bias
Patient-friendly approaches that minimize burden
Global expertise
With international ICH-GCP compliant research experience, we deliver:
Cultural adaptation services,
by request
Multi-language capabilities
Rigorous transcription and translation procedures and highly skilled medical translators
Comprehensive support for international patient research
We put the science first and foremost
Listen to Anna Ryden (PhD), our Chief Scientific Officer, explain how we work with clients and interviewers—to gather high quality patient experience data for regulatory submission.
Better outcomes start with patient insights
CLINIGMA® delivers meaningful patient experience data for better regulatory outcomes and competitive advantage.
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