COA Consulting

COA Consulting

COA Consulting

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.

Who we are

Who we are

Who we are

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.

Photo of Popocatépetl erupting at night
Photo of Popocatépetl erupting at night
Photo of Popocatépetl erupting at night

Photo (© Serrano, D. Popocatépetl erupting at night, Puebla, MX):

Photo (© Serrano, D. Popocatépetl erupting at night, Puebla, MX):

Photo (© Serrano, D. Popocatépetl erupting at night, Puebla, MX):

Services

Services

Services

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.

Psychometric validation of COA Instruments and Scores

We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.

Psychometric validation of COA Instruments and Scores

We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.

Psychometric validation of COA Instruments and Scores

We support pre-approval COA programs through psychometric validation of new or legacy COA instruments. Our team has extensive hands-on experience conducting psychometric analysis (both modern and classical methods) and reporting of evidence.

Analysis and Interpretation of COA data

We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.

Analysis and Interpretation of COA data

We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.

Analysis and Interpretation of COA data

We support post-approval COA differentiation strategies with innovative statistical methods implemented to illuminate the strength of your COA data.

Regulatory COA Strategy Consulting & Support

Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.

Regulatory COA Strategy Consulting & Support

Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.

Regulatory COA Strategy Consulting & Support

Our COA Regulatory Strategy/Support is informed by our long experience in this field and a close understanding of existing regulatory guidance (draft or final), as well as historical and current trends emerging in ongoing regulatory interactions.

Experience

Experience

Experience

We bring the results

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Years of Experience

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Publications

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FDA and EMA Submissions/ interactions supported since 2014 across different clinical programs

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Different disease areas worked in

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COA measures developed and/or validated

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FDA DDT COA grant won and completed

Testimonial

Testimonial

Testimonial

“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

Insights

Insights

Insights

What we have been up to lately…

Read our latest news and insights.

Have a chat with us

Got any questions? Contact us and we'll be happy to help.