Validate your COA where it matters: In the real world
Need defensible regulator-ready evidence that your chosen clinical outcome assessment works in a new population or mode of use?
Have questions?
Get the answers you’re looking for. Contact us. No obligation.
Get In Touch
Phone: +1.833.726.8486
Helpdesk: info@santium.com
Supporting Solutions
Related Guidances
Clinimetrics and Outcomes Research
Qualitative evidence to support COA use in new populations
Data collection in clinical research means generating the qualitative evidence needed to confirm that a clinical outcome assessment (COA) is understood, relevant, and feasible in a new population or mode of use. Instead of assuming that concepts transfer cleanly across age groups, languages, or clinical settings, we evaluate how real patients, caregivers, and clinicians interpret and interact with the instrument.
Each engagement is tailored. For common conditions, we may run a full set of interviews and usability sessions. For rare or hard-to-reach populations, we design lean, high-value approaches that still meet regulatory expectations for content validity and appropriateness for use.
Our role is to provide clear, defensible evidence that is grounded in clinimetrics and patient experience, and that supports COA adoption, adaptation, or digital implementation in global clinical trials.
Recruitment
We partner with sponsors, sites, and patient organisations to find the right participants. Recruitment plans are tailored to population size, rarity, and illness burden, balancing rigour with practical and ethical considerations.
Fieldwork
Interviews, test item administration, focus groups, and usability sessions are led by trained moderators familiar with the condition and COA. We explore comprehension, relevance, feasibility, and usability in real-world settings.
Evidence & Reporting
Study findings are presented as clear, regulator-aligned evidence accompanied by practical recommendations for COA adoption, adaptation, or digital use. For COAs found to be unsuitable, a detailed report is provided.
Practical Data Collection Aligned with Guidances for Industry
Meeting Regulatory Expectations
We begin by aligning with FDA, EMA, and ISPOR expectations for qualitative COA evidence. This means clarifying what must be demonstrated for the target population or mode of use, such as concept relevance, target population profile, interpretability, or usability within a clinical research context.
Evidence must reflect the experience of the population for whom the COA will be used. Depending on the study aims, we recruit patients, caregivers, clinicians, or raters who can provide meaningful insight into concept relevance, item interpretation, symptom experiences, or clinical feasibility.
Through structured interviews and targeted discussion prompts, we explore conceptual clarity and the relevance of the content to the new target population, examining how participants understand the concepts, items, instructions, and response options. The goal is to confirm that the COA captures the intended concepts of interest, encompasses relevant domains that reflect outcomes important to patients and clinicians, and performs as expected in the new population or context.
Findings are synthesized into clear, defensible evidence that supports the COA’s appropriateness for use. Reports align to regulatory expectations, providing transparent documentation of relevance, comprehension, usability, and any recommendations for refinement or further evaluation.
When this matters
When to Engage Santium
Data collection becomes essential whenever a COA is being used outside the population, age group, context, test-retest timeline or mode of administration in which it was originally validated.
Sponsors typically engage Santium when:
- A COA is introduced into a new age group, disease area, or cultural context.
- Regulators or ethics committees request qualitative evidence demonstrating relevance and comprehension.
- A multimodal paper-and-pencil battery is being migrated to eCOA and requires confirmation that the digital format is usable and that scores remain interpretable.
- Early feasibility work is needed to understand whether the COA is practical for use in real-world clinic workflows.
- A limited number of patient or caregiver interviews can offer high-value insights for rare or hard-to-reach populations.
Our goal is to generate the level of evidence that is proportionate, defensible, and aligned with your development stage and regulatory strategy.
Why Santium
Built for high-stakes COA decisions
Scientifically Grounded
Our process is rooted in measurement theory and clinical relevance, ensuring data that support high-stakes decisions and align with FDA/EMA expectations for content validity.
Operationally Practical
We adapt methods to real-world study constraints—rare-disease recruitment, pediatric needs, or complex digital adaptations—without compromising scientific integrity.
Action-Focused
Findings are structured, prioritized, and ready to integrate into COA selection, adaptation, linguistic validation, or eCOA implementation.
Relevance to Target Population
Resonates with intended patients
Consistent Item Interpretation
Consistent understanding of items across participants
Real-World Usability
Feasibility in real clinical settings
Early Evidence Gaps
Early risks and uncertainties identified
Evidence supporting repeated use
When COA goes beyond a single study
Some sponsors and COA developers choose to pursue regulatory qualification for outcome measures intended for use across multiple clinical programs. Programs such as the FDA’s Clinical Outcome Assessment (COA) Qualification Program are designed to establish confidence that a measure is appropriate for a clearly defined context of use. This evidence is typically generated early, before formal validation decisions are made.
While formal qualification is optional and typically pursued over time, early evidence showing that a COA is relevant, understood, and feasible in its intended population is foundational to that pathway. This includes demonstrating that concepts resonate with patients and/or caregivers, instructions are interpreted consistently, and the instrument functions as intended in real clinical settings. Our approach reflects direct experience with the regulatory thinking that shaped the FDA’s Drug Development Tool (DDT) guidance and COA qualification framework.
Santium’s data collection services can be used to support these objectives by generating structured patient, caregiver, and clinician insights that inform context-of-use discussions, regulatory interactions, and longer-term development strategies. Sponsors choose the level of commitment to full qualification and fixed study designs.
Our expert translators specialize in medical and scientific translation and terminology, and provide high-quality translations that support patient safety, regulatory compliance, and preserve the psychometric integrity of each outcome measure.
What this type of support typically focuses on:
- Confirming that core concepts are relevant to the intended population
- Understanding how patients and clinicians interpret items and instructions
- Identifying usability or feasibility considerations early
- Producing documentation that can inform regulatory discussions or future development steps
Our approach
The Santium method – where precision meets purpose
We apply a unified scientific framework across all our services, grounded in conceptual clarity, measurement theory, and an understanding of how regulators evaluate evidence in practice.
For data collection, that means every interview, usability session, or evidence-generation activity is designed to produce findings that are defensible, reproducible, and aligned with your regulatory and operational goals.
Clients choose Santium for our ability to balance precision with understanding.
We adapt complex materials into content that communicates clearly and performs reliably, whether for regulators, clinicians, or patients, helping organizations build trust and consistency in their markets.
COA Fit-for-purpose Evaluation
frequently asked questions
Common questions about COA-focused data collection to confirm content validity in new target populations, regulatory expectations, sampling, and linguistic validation.
There is no fixed number. Psychometric validation needs a bare minimum of n=100, preferably n=500+. Beyond n=100 is not practical for commercial research, for multiple valid reasons. However, FDA and ISPOR emphasize fit-for-purpose sampling, which means the sample must reflect the target population and the evidence needed. Time is also always a factor. For rare diseases or highly burdened populations, smaller samples are acceptable when they meaningfully address the study questions. Talk with us about your case.
No. Qualitative evidence complements, but does not replace, quantitative validation.
Consistent with established measurement standards (e.g., the Standards for Educational and Psychological Testing published by AERA, APA, and NCME), qualitative evidence is typically generated early to support decisions about relevance, comprehension, and intended use.
Quantitative validation remains necessary when measurement properties must be established or confirmed.
In most cases, yes, especially if findings indicate that wording, scoring, or conceptual framing may need modification. We can support communication with the developer and ensure the evidence aligns with their expectations.
Most of the time, we can. For some conditions, especially in younger age groups and specific severities of decompensation, we face the same issues as study sponsors and their patient recruitment agencies. In some cases, and subject to customer’s approval, there may be a more accessible group with a similar symptom and/or needs profile that could fill in as a model for the target group.
We design lean, high-value approaches tailored to limited recruitment pools, including pediatrics, caregivers, and rare-disease communities. Feasibility is a core part of our planning process.
In some cases, yes. We can support documentation for IRB/ethics review, including study guides, participant materials, and data-handling procedures.
Sponsors typically receive:
- evidence plan
- semi-structured interview guides
- qualitative findings
- clear recommendations for next steps
Deliverables are tailored to your regulatory and operational needs.
Yes. Our reports follow FDA and EMA expectations for qualitative COA evidence and can be included in briefing documents, protocol amendments, and validation packages.
Sometimes the COA’s content simply doesn’t work in the new context. Whenever it makes sense to continue, we provide clear recommendations, which may include refinements, alternative measures, or further targeted evidence collection. Our goal is to support informed decision-making, not merely summarize feedback.
SIGN UP FOR UPDATES
KEEP IN TOUCH
Instrumenting meaningful outcomes.
