NEW COAS IN ONCOLOGY GUIDE
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Read the GuideOur dedicated team of experts offers unparalleled support through all phases of clinical outcome assessment (COA) development. From initial concept and planning to rigorous testing and validation, we ensure your tools are tailored for precision and reliability. Whether designing COA tools or creating protocols for global clinical trials and healthcare applications, we help you ask the right questions, establish meaningful contexts, and derive the most accurate insights.
By leveraging our expertise, you’ll gain a competitive edge in generating scientifically robust, actionable evidence that aligns with the critical demands of your therapeutic area. Our customized approach ensures your COA tools meet regulatory standards, enhance decision-making, and deliver measurable value for your clinical and real-world objectives.
To ensure your COA tools are relevant, comprehensive, and understandable, our in-house qualitative research teams conduct concept elicitation and cognitive debriefing interviews with patients, caregivers, clinicians and key opinion leaders.
Our quantitative researchers and analysts are trained in both classical test theory and modern psychometric methods (Rasch and Item Response Theory). They work alongside your teams to generate the psychometric evidence needed to support the use of your COAs in treatment trials and other clinical applications according to FDA guidelines.
Our tailored approach ensures that your clinical outcome assessment (COA) strategy is not only aligned with regulatory requirements but also optimized to meet the unique needs of your therapeutic area and study objectives. By integrating both qualitative and quantitative methodologies, we provide a robust foundation for designing, implementing, and validating COA tools that deliver reliable and meaningful data. From developing comprehensive COA dossiers and regulatory briefing packages to preparing for and participating in critical Type B and Type C meetings with regulatory authorities, our team offers end-to-end support. We help you navigate complex regulatory landscapes, ensuring your COA strategy meets the expectations of agencies such as the FDA and EMA while maintaining scientific integrity and relevance. With our expertise, you can confidently advance your program with tools that are fit-for-purpose, actionable, and defensible in the global healthcare market.
