Every trial resolves to one number. That number is the whole asset.
A Clinical Outcome Assessment is the instrument that produces it — a structured measure of how a participant feels, functions or survives. COAs define a trial's endpoints: the evidence a regulator uses to decide whether a treatment works, and the basis of the label it is sold under.
Everything upstream — the molecule, the sites, the participants, the years — resolves to whether that one measured number separates from control. It is the most consequential measurement in the industry, and the least industrialised.
The measurement breaks in five places.
Each break has a known cause and a known fix. Our solutions are built around them.
The instrument
Instrument design constrains everything downstream. Most COAs in use were built for paper and are licensed by a handful of rights-holders, so the people running the trial cannot adapt them for digital or decentralised capture.
eCOA development & licensing →Administration
How an instrument is administered is part of the measurement. Vary the procedure and you vary the measure — and experienced raters are routinely trained differently on the same administration rule from one protocol to the next.
Rater training & certification →Scoring
Rater reliability drives sample size. Every point of unreliability is variance that has to be bought back with participants — raters who have never been calibrated diverge widely, and the difference is paid for in participants.
Endpoint quality surveillance →Who gets enrolled
Unreliable baseline scoring selects the wrong participants, and participants who are not sick enough get better on placebo. The result is a placebo response the trial has to beat before the treatment effect even starts.
Endpoint quality surveillance →Clinical adjudication
Adjudication is still a manual, cross-platform exercise. The evidence for a single endpoint event sits in ePRO, EDC, labs, imaging and safety systems that do not talk to each other, so determinations are slow, inconsistently evidenced and hard to audit after the fact.
Clinical endpoint adjudication →Which of the five is your endpoint exposed to?
Bring us the protocol and the instruments. We will map the exposure and tell you what is worth covering.
Talk to us about your study