Three stages, in order, every time
Most engagements start at Educate, where the risk is lowest. If you're already past that, we start where you are — but we never skip Evaluate before Execute.
An informed decision
Briefings, training, and Academy content that bring your team current on the regulatory, clinical, or AI-governance landscape — before you commit to anything.
Days to weeks · fixed fee or open enrollment
Formats: briefing, workshop, Academy course · Who's in the room: your leadership team, our named principal
A bounded, graded assessment
A fixed-fee, fixed-scope review of your program, operation, or AI exposure — honestly graded, with a prioritized roadmap you own outright, whoever executes it next.
3–4 weeks · fixed fee
Formats: readiness assessment, red-team review, maturity assessment · Who's in the room: your program leads, our named principal, relevant specialists
Embedded delivery
Named reviewers, fractional leadership, or an enablement retainer — running alongside your work, scaled to activity, documented by default.
Ongoing · retainer or fixed-scope project
Formats: continuous oversight, co-delivery, fractional role · Who's in the room: the full credentialed team assigned to your program
The same path, in your seat
What Educate, Evaluate, and Execute actually look like depends on which door you came in.
| Stage | Biotech & Pharma | CROs & FSPs | Technology & AI Vendors |
|---|---|---|---|
| Educate | Executive briefing on novel-modality safety, FDA pathways, and AI expectations | Sales enablement; novel-therapy safety training; governed-AI fluency via the Academy | Regulatory landscape briefing for AI in drug development |
| Evaluate | Program Readiness Board; IND/BLA red-team; IHASG Readiness Assessment; AI governance audit | Five-dimension maturity assessment; AI assurance gap analysis | Clinical validation and regulatory readiness assessment |
| Execute | Protocol and signal definitions; fractional CMO/CTO; Continuous Medical Oversight; vendor orchestration | Co-delivery; white-label IHASG; modernization lighthouse; credentialing program | Expert-in-the-loop review; validation dossier; co-go-to-market |
Four layers of accountability, one named owner
Every engagement escalates the same way — simple to explain, and simple to inspect.
Named principal
Owns the engagement and every material decision — the single point of accountability.
Credentialed experts
Physicians and specialists from our network, matched to your modality and stage.
Delivery partners
Vetted CROs, FSPs, and specialist vendors, orchestrated under our governance — named in the SOW.
AI-enabled solutions
The Workbench and other tools that make the layers above faster and fully documented — never a replacement for them.
A decision that exceeds a layer's authority escalates up, not sideways — every escalation is logged, so the record shows who decided and why.
Five principles, every engagement
You own everything we produce
Every deliverable is yours outright — usable whoever advises or executes next.
Named accountability
A principal is named on every engagement — never an anonymous team.
Independence
We don't execute your trial and don't audit our own algorithm — the judgment is the product.
Documented by default
Who decided, when, under what criteria — captured as the work happens, not reconstructed for an audit.
No hourly-rate staffing
We price for the decision, not the headcount — see Commercial Models.
Right fit · not the right fit
Built for
- ✓Teams in regulated clinical work who need judgment and proof, not just tools or headcount
- ✓Programs facing an inspection, a sponsor qualification, a diligence cycle, or a first-in-human milestone
- ✓Organizations whose AI ambitions have outrun their governance — pilots stalled at validation and sign-off
- ✓Leaders who want deliverables they own outright, not a retainer dependency
Not the right fit if
- ✕You need pure headcount staffing with no governance or specialization layer — that price war is one we deliberately sit out
- ✕Your program is pre-IND with no near-term submissions — start with our free Readiness Check first
Start at Educate, Evaluate, or Execute — we'll tell you which.
Twenty minutes to scope the right first step, and see how the commercial models line up with it.