Clinical operations, regulatory submissions, medical affairs and commercial teams each run on a validated platform, and the handoffs between them are manual. The work between systems is where the hours, the errors and the compliance risk sit.
Read the "before" and find yours. Most pharmaceuticals and life sciences teams start here and find that half of what they assumed needed AI didn't.
Before
Site activation runs on three parallel trackers doing the same job, and the real sequence exists only in the CRA's head.
After
One tracker, one owner per site, one written sequence. Everyone knows what's missing and who's on it.
Before
Submission components are collected and version-checked by hand from four systems, over weeks.
After
Deterministic assembly and version control from the systems of record. A missing or outdated document halts the build loudly.
Before
Inbound inquiries wait days for a reviewer to search approved content and draft from scratch.
After
An agent reads the inquiry, drafts from approved content, and routes to a medical reviewer: read-only first, drafting once it agrees with reviewers.
Before
Deviations are closed one at a time; the same root cause is written up across sites without anyone seeing it.
After
Recurring causes surface monthly across sites. Quality adjusts controls, logs the change, and repeat deviations fall.
The left column is what we usually find. The right column is the same process, one level at a time, each step is paid for by the one before it.
Baseline these before anything changes. The Survey instruments them; the Pilot is measured against them.
| Metric | How to measure it | Who it moves |
|---|---|---|
| Site activation time | Days from site selection to first patient in | Clinical ops |
| Submission assembly time | Hours per submission spent assembling and checking | Regulatory |
| Inquiry response time | Days from medical inquiry to approved response | Medical affairs |
| Repeat deviations | Deviations sharing a root cause with a prior one | Quality |
We build on your platforms and inside your change control.
Reconciliation work leaves the week.
The system produces the trail and the attribution as it runs, so nothing is assembled for the audit.
We start with what you own. None of these is a partnership we take margin on.
With study start-up, mapped. It's the step that returns hours before any software is bought, and it makes everything after it cheaper. The assessment tells you whether your process is already past that point.
Usually not at first. Most of the delay in site activation to first patient comes from manual hops between systems, which deterministic rules remove. An agent earns its place only where the inputs vary, and we start it read-only.
The ones you already run. We start with capability you license and nobody switched on, and we take no margin on anything we recommend. If a different tool would remove a real roadblock, you get the case and the switching cost in writing.
Bring one process. You leave knowing which level it's on, what to fix first, and whether it's worth doing anything at all.