What independence actually buys you

Advice that costs us money to give

We are privately held, we own no platform, and we earn nothing on what you buy from anyone else. A firm with a product to place cannot give you the answer below.

A worked example

The proposal we made smaller

Every consulting firm claims to be objective. This is what it looked like the last time it cost us something.

A recent engagement

A clinical-stage client asked us to price a safety function for two INDs. Our first proposal included a validated, hosted safety database — a substantial six-figure platform line, and revenue for us.

The client came back and asked whether it could be run manually instead. It could, and we said so: for their case volumes, at their stage, a disciplined manual process meets the FDA's requirements. So we withdrew the platform from our own proposal.

Then we wrote two sections nobody asked for. One set out plainly what a manual system does not give you — duplicate cases have to be caught by a person, every change has to be recorded by hand rather than by the software, and the residual error rate is higher. The other listed the specific triggers at which we would come back and tell them to buy the platform after all.

The revised proposal was materially smaller than the first. That is the trade we make, and it is the reason almost all of our work arrives through someone who has already tested the advice.

What that engagement shows

We priced against our own interest. The recommendation reduced our own fee, because it was the right call at that stage.
The downside was written down. The limitations went into the proposal itself, in a section the client had to read before signing.
The exit was designed in. Records were structured so that moving to a validated system later is a data-mapping exercise, not a re-entry of every historical case.
The review is scheduled. Quarterly governance, with the change-course triggers formally assessed each time — not left to whoever notices first.

Why this is the whole business model. A firm with a product to place cannot give you this answer, and a firm being paid by the hour has no reason to shorten its own scope. That structural position is what you are actually hiring.

The structural position

What we are not

Most conflicts in this industry are structural rather than personal. The reliable way to avoid them is to not be in the business that creates them.

Not a CRO

When we help you select and qualify a CRO, we are not competing for the contract, and we have no volume commitment with any of them to protect.

Not a CDMO or a lab

We audit manufacturing and testing partners on your behalf. We do not manufacture, we do not test, and we do not receive anything for the introduction.

Not a notified body

We prepare your technical documentation and we help you close nonconformities. We have no role in certifying you, so nothing constrains how hard we argue your case.

Not a software vendor

We help you choose, validate and — where it is the right answer — decline an eQMS or safety platform. We do not resell one, and we hold no licences you would be paying for.

The one thing we do sell is our time, which creates its own incentive to keep an engagement running. Two things hold it in check: we scope work in writing before we price it, and we tell you in advance when a workstream is trending over its estimate rather than at the point the invoice arrives.