Somebody has to read every one of them
Every adverse-event report a pharma company receives has to be read, judged, coded and filed inside a fixed number of days. It is one of the largest pieces of unglamorous, error-intolerant work in the industry, and almost all of it is done by hand.
Why this, and why now
Case processing resisted automation for two decades for the same reason clinical text resisted everything else: the input is a voicemail from a worried daughter, a fax with handwriting in the margin, a Japanese case report. Rules-based extraction never had a chance against that, so the industry did the only thing it could and threw people at it — tens of thousands of them, offshore, on a clock.
Reading that material reliably is now possible. What that changes is not a feature in a safety database; it is the cost structure of an entire services industry sitting next to one.
We think the right shape for that is a managed service rather than a licence. The buyer’s problem is not that they lack software — they have plenty. It is that they are paying per case for human attention, and the attention is the part that can now be supplied differently.
Five things we are not willing to trade
The report is a person
Behind every case in the queue is someone who took a drug and something went wrong. The work is dull by the ten-thousandth case, and that is exactly when it starts to get missed. Automating it is not about efficiency for its own sake — it is about the tenth-thousandth case getting the same attention as the first.
Show the work or do not ship it
In a GxP process an output nobody can trace is an output nobody can use. Every field links to the source text that produced it. If we cannot show the reasoning, the feature is not finished.
Be honest about the hard ones
The entire product rests on escalating genuinely ambiguous cases and only those. The temptation to quietly widen what counts as routine — to hit a throughput number — is the thing that would destroy this, so we treat that boundary as untouchable.
Sell the contract, not the seat
The incumbents sell systems of record and let someone else staff the work. That is backwards. The labour is the cost, the labour is the risk, and the labour is what we take on.
Do not overclaim to a quality unit
This industry has been sold a great deal of vapour. A vendor that overstates its validation status or its accuracy gets found out in an audit, and takes its client's inspection record down with it.
Small, and hiring ahead of the roles
There is no roles board yet, and posting invented vacancies would waste your time. If you have processed cases, run a safety database, held a QPPV role, or built systems that had to survive a regulatory inspection, write to us with what you have done.
We are particularly interested in people who have sat in the queue itself. The product fails in ways only a drug safety associate can see coming.
Safety teams, CROs, and people who want to build this
All three start in the same place.