COA source validation and patient feedback services

RWS helps you strengthen your COAs by validating them with real patients, aligned with regulatory expectations, and ready for global deployment. We offer not just services, but peace of mind.
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A growing opportunity in COA validation

Pharmaceutical sponsors face increasing regulatory expectations to validate that Clinical Outcome Assessments (COAs) are well-constructed, understood and relevant to patients. Agencies like the FDA and EMA demand evidence of patient involvement in instrument development, particularly for PRO (Patient-Reported Outcome) measures. 

This creates a timely opportunity: enhancing English source instruments before translations or deployment in trials can reduce regulatory risk and ensure smoother global execution.

Tailored offerings

RWS is uniquely positioned to support this need through specialized services focused on COA source validation and patient feedback collection. 

Our offerings are tailored to produce instruments that are clear, patient-centric and regulator-ready, while we additionally offer enhanced and tailored cognitive interviewing services aimed at generating patient feedback to address specific regulatory questions and concerns. These services are backed by a seasoned team of COA validation and research analysts, rapid turnaround times and a proven track record with leading pharma clients like Roche, AstraZeneca, RTI and Novartis.

Core service areas

Face validation

combines expert review and patient interviews to confirm the instrument's relevance, clarity, and content validity, and to provide suggestions for design or wording updates as needed.

Readability testing

evaluates and enhances the instrument's language to match health literacy best practices and ensure suitability for use with a given target population.

Usability testing

ensures that a demographically diverse set of patients can interact effectively with eCOA platforms or paper-based instruments.

Translatability assessment

identifies and addresses potential challenges in translating the English source version of a novel or existing instrument into other languages.

Clinician review and enhanced debriefing

optional, bespoke services to deepen the validation and strengthen regulatory documentation.

Why RWS?

Deep expertise in COA and linguistic validation

We bring decades of experience in linguistically validating COAs across languages and cultures. This includes source language refinement to ensure instruments are conceptually sound before translation or regulatory submission.

Dedicated COA validation team

Our specialized team includes linguists, psychologists, outcomes research and public health experts focused exclusively on COA validation.

Patient-centered methodology

We integrate the patient voice throughout its COA processes. We conduct direct patient interviews, usability sessions and readability assessments, ensuring instruments resonate with real-world users.

Regulatory alignment

Our methodologies adhere to FDA and EMA guidance, with deliverables designed to meet submission requirements. We help sponsors anticipate and address agency concerns proactively.

Flexible and bespoke services

Beyond standard offerings, we provide tailored solutions such as clinician reviews, enhanced debriefings, and hybrid validation approaches combining multiple qualitative techniques capable of addressing the unique needs of each instrument and sponsor. Drawing from a broad set of both traditional and specialized validation services, we craft a fit-for-purpose methodology to match any request.

Rapid and scalable delivery

With a global network and scalable processes, we deliver high-quality validation services within compressed timelines. This agility is essential for sponsors responding to regulatory feedback or preparing for late-stage trials.

Proven success across clients

From addressing EMA concerns for a GI symptom diary to supporting oncology PROs with the NCI, RWS has demonstrated success across therapeutic areas and study phases. Our ability to execute quickly and thoroughly has earned the trust of top-tier clients.
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Regulatory and commercial impact

Our validation services directly support regulatory compliance and patient engagement goals. By ensuring content validity upfront, sponsors can: 

  • Minimize the risk of regulatory delays or rejections. 
  • Improve patient comprehension and data quality. 
  • Enhance the scalability of COAs across global markets. 
  • Build confidence with copyright holders and regulatory reviewers.
RWS is a trusted partner in COA development, helping sponsors create instruments that are clear, compliant and centered on the patient experience. Our COA source validation and patient feedback services deliver scientific rigor with the agility required in today’s clinical research environment. As regulatory expectations evolve, RWS is committed to supporting sponsors with the tools, expertise and insight needed to succeed.

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