BuildWhat to build, and what to measure
Most evidence problems are settled before anyone writes a protocol, in the product decisions that fix what you can ever demonstrate.
We work with teams at that point:
- Defining the clinical use case
- Establishing what has to be true for a clinician to act on your output
- Building the path from what you can claim now to what you need to claim
We also hold the named Clinical Safety Officer role under DCB0129, for companies who need a registered clinician and do not have one.
See what’s includedMore on the CSO roleAssessWhether the claim holds
Would a clinician act on this number? That is a harder question than whether the number is accurate.
You get the claim you can defend, the claim you cannot, and what would close the gap.
See what’s includedMore on investor diligenceAssureWhether it survives real use
A hazard log built from intended use records only the use you imagined, not the one on a short-staffed night shift, by someone interrupted twice, who does not entirely trust it.
See what’s includedHow we workSix methods sit behind every engagement: clinical use-case definition, claim traceability, signal interrogation, use assessment, evidence gap specification, and regulatory positioning. Which ones apply depends on where your product is, not which package you buy.
Defining the clinical use case needs a registered clinician who has held the clinical problem, and who can also judge whether the measurement behind it holds. It cannot be learned from a standard, which is why a regulatory consultant cannot do it for you.