Empowering Healthcare
Through Value-Driven Data.

We offer strategic guidance on creating tailored COA strategies, starting with an extensive literature review and intelligence gathering to deliver robust recommendations that will enhance your product's success among critical stakeholders, including patients, physicians, and payers.

We offer expert clinical trial advice, including the correct implementation of COAs, statistical planning, and comprehensive support services such as writing protocol sections, SAPs, and CSRs, advising on translation processes, and using electronic data capture systems.

We offer expert regulatory advice and support to navigate the complexities of obtaining COA labeling, with extensive experience in liaising with the FDA and EMA, developing regulatory documentation, and attending key meetings to ensure a smooth regulatory approval process.

We provide bespoke training to educate internal teams on developing robust COA strategies, navigating label acquisition, addressing payer scrutiny, and utilizing innovative statistical approaches tailored to meet specific organizational needs.

We offer a sophisticated Mixed Methods approach, seamlessly blending qualitative and quantitative data collection and analysis to thoroughly investigate and address research questions in developing Clinical Outcome Assessments (COAs).

We offer strategic gap analysis for COAs to determine whether measures are fit for purpose from regulatory and payer perspectives. We provide guidance on addressing any gaps in content validation, psychometrics, or meaningful change thresholds before using them in pivotal trials.

We conduct in-depth qualitative exit interviews with participants at the conclusion of clinical trials to gather direct and valuable feedback on their experiences throughout the study.

We specialize in designing and executing observational, prospective, real-world studies for epidemiological discovery, psychometric evaluation of COA measures, and refinement of target populations.

We specialize in creating comprehensive Statistical Analysis Plans (SAPs) that meticulously plan every aspect of data handling, ensuring the integrity and objectives of the study are upheld.

We specialize in creating and defending COA evidence dossiers for FDA and EMA submissions, detailing measure development, psychometric strength, meaningful change thresholds, and clinical trial implementation aspects like translation rigor and training protocols.

We specialize in designing and implementing prospective quantitative studies that collect Clinical Outcome Assessments (COAs) using priori-defined statistical and psychometric methods with adequately powered samples to ensure valid statistical inference.

We craft bespoke analytic strategies for psychometric, statistical, and mixed-methods research studies, including prespecified analysis plans with full mock tables, listings, and figures.

We excel in crafting quantitative reports, including statistical and psychometric results, tailored to the needs of various stakeholder audiences such as patients, clinicians, regulators, and payers.

We specialize in collaborating with sponsors to support HTA submissions, providing expert statistical evidence derived from data collected in Phase 3 clinical trials across the UK, France, England, and Germany.