Illuminating the Patient Voice Through Rigorous COA Evidence Generation
We provide comprehensive and innovative COA consulting with a specialised focus on psychometric evaluation, data analytics, and navigation of regulatory pathways.
Contributing to the success of COA programs for over 20 years
At The Psychometrics Team we are focussed on two things: Generating the best COA evidence possible and effectively navigating the COA regulatory process.
Both our principles have extensive FDA (DCOA/Division) & EMA experience and have served as Psychometric Service Area Leads in Industry for over 10 years.
How we can help you
We provide three primary services relating to two areas: Analysis of COA data and COA Regulatory Strategy/Support. Analysis of COA data can be decomposed into pre-approval and post-approval activities.
We bring the results
Years of Experience
Publications
FDA and EMA Submissions/ interactions supported since 2014 across different clinical programs
Different disease areas worked in
COA measures developed and/or validated
FDA DDT COA grant won and completed
PubMed Links:
“We think we’re pretty good at what we do, but you don’t have to take our word for it”
“I have had the pleasure of conducting award-winning research in migraine and dementia with Daniel since 2006 and with Lauren since 2022. Daniel is an uncommonly thoughtful analyst. What sets Daniel apart is his commitment to understanding clinical problems and to use statistical results in ways that effectively communicate the meaning of data to various stake holders, including prescribers, regulators, and patients.”
Richard Lipton
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