Protocol Integrity Audits for Funds & Boards
Surface decision-break risk before capital is committed.
When a milestone fails under scrutiny, the problem is not always biology. Often it is decision logic that breaks under real-world variance. We formalize that logic, stress-test the assumptions, and deliver board-ready, forwardable artifacts that make protocol risk visible before it becomes expensive.
We don’t add complexity. We make existing assumptions visible.
Best for: IC screening • board checkpoint review • milestone diligence • pre-commit protocol risk triage
Not a CRO. Not a biostats service. Decision infrastructure for governance.
No sensitive data required • de-identified example available • designed to be forwarded internally
The failure mode funds feel too late isn’t always biology. It’s design fragility.
Most protocol decisions do not fail outright. They become non-decisive.
And non-decision is rarely made explicit in the decision model.
It usually appears too late—as ambiguous readouts, adjustment pressure, or confidence that weakens under operational variance.
Most funds already diligence mechanism risk well. But many late-stage losses come from a different category: protocol choices whose assumptions fail under real-world variance—sites, missingness, adherence, endpoint behavior, and operational drift. When that happens, you rarely get a clean failure. You get a readout that becomes harder to interpret, harder to defend, and harder to act on. That is where capital gets damaged.
If this is not audited before commitment
- You may fund a milestone that cannot produce a decisive signal under real-world drift.
- You inherit decision debt: protocol choices that were accepted internally but do not survive written scrutiny.
- You face adjustment pressure later—when interpretability is already weakened.
- You leave diligence with confidence that proves less durable than the base-case plan suggested.
What you buy: an auditable decision trail
Three forwardable artifacts for governance review
Protocol Risk Register (MRR)
Ranked assumptions, failure modes, and “what must go right” conditions—linked to milestone exposure.
Milestone Fragility Map
Which milestones are assumption-sensitive—and what would make the readout ambiguous, delayed, or decisive.
Board-ready Decision Note
A forwardable memo with key risks, minimum fix set, questions to ask, and thresholds that change conviction.
Artifacts are inspectable (LaTeX/PDF), versioned, and reviewable—not slide decks or black-box outputs.
Visibility first. Decision clarity next. Defensibility where it matters.
What decision are you at right now?
Pick the governance decision moment you need to de-risk today. Same Method2Model logic layer at the top—applied through a familiar decision library below.
Most governance cases begin in one of four moments: before commitment, before scrutiny, during drift, or after ambiguous results. Open only the block that matches your situation.
Governance modules (same library, different packaging)
These modules are entry points, not a linear path. Open the block that matches the governance decision in front of you.
- Design — before protocol lock / capital sign-off
- Review — before partner, regulator, or board scrutiny
- Mid-Study — during execution under drift / adjustment pressure
- Post-Readout — after results, when next-step decisions depend on interpretability
- Asset — continuity, auditability, and reuse
Phase A — Design (Before you run it)
VP question:
What breaks first—and what does that do to the milestone?
If you don’t do it:
you fund exposure that becomes ambiguous once real-world variance hits.
We deliver:
Protocol Risk Register (MRR) + fragility notes + minimum fix set
We surface:
recruitment feasibility collapse • endpoint mismatch • detectability erosion under drift
Best used:
2–6 weeks before protocol lock / capital sign-off
VP question:
Is the study powered for the world you’ll actually face?
If you don’t do it:
you pay for a “powered” trial that can’t produce a decisive signal under variance.
We deliver:
power-drift scenarios + N/budget trade-offs + “what changes conviction.”
We surface:
dilution • variance inflation • missingness/non-adherence
Best used:
before approving N, budget, timeline
VP question:
Are we funding measurement burden that doesn’t move the decision?
If you don’t do it:
you spend on panels, assays, or timing windows that increase cost and missingness without improving inference.
We deliver:
minimal must-measure set + timing windows + burden/cost flags.
We surface:
low-information markers • timing-window misses • unnecessary collection burden
Best used:
before approving assay scope, timing windows, or data burden
VP question:
Is the regimen robust—or only optimal on paper?
If you don’t do it:
regimen fragility under adherence or exposure drift can erase signal or distort the benefit-risk picture.
We deliver:
regimen scenario matrix + robustness options + defensible dose rationale memo.
We surface:
exposure variability • compliance realism • efficacy–toxicity trade-offs
Best used:
before locking dose, interval, or adherence-sensitive regimen assumptions
VP question:
What transfers—and what breaks—across settings, phases, or real-world rollout?
If you don’t do it:
you scale a result that does not survive the next context and discover the break too late.
We deliver:
transferability map + adjustment scenarios + scaling conditions
We surface:
population shift • exposure shift • workflow/endpoint shift
Best used:
before phase transition, geographic expansion, or real-world scaling
VP question:
Will the pathway hold at scale—or break at handoffs and capacity constraints?
If you don’t do it:
execution bottlenecks create outcome variance independent of biology.
We deliver:
bottleneck map + drop-off points + intervention scenarios
We surface:
bottlenecks • drop-offs • capacity constraints
Best used:
before rollout, site expansion, or capacity-dependent implementation
Not sure which audit block fits your situation?
Stage-0 identifies which decision risks matter now, what is modelable, and where the lowest-friction next step sits. It is not a consultation. It is the entry point to the audit logic. You receive a short written verdict—modelable as-is, modelable with changes, or not a fit right now—plus the audit path most appropriate for the decision in front of you.
It clarifies where risk becomes visible first—before more time, capital, or confidence is committed.
Phase B — Review (Before external scrutiny)
VP question:
Can the team defend the design logic under partner, regulator, or board scrutiny?
If you don’t do it:
you trigger rewrite cycles, delay, or partner hesitation because the rationale does not hold under pressure.
We deliver:
defensibility pack + assumptions log + claim-to-endpoint alignment note
We surface:
unstated assumptions • logic discontinuities • claim–endpoint mismatch
Best used:
before board review, diligence meetings, partner discussions, or regulator-facing scrutiny
Phase C — Mid-Study (During drift/amendment pressure)
VP question:
What adjustment reduces risk without breaking interpretability?
If you don’t do it:
you spend more and still end with an uninterpretable readout—the worst capital outcome.
We deliver:
constrained scenarios + lowest-risk amendment options + board-ready rationale note
Guardrail:
Not a replacement for clinical or regulatory oversight; scenario transparency only.
Best used:
when drift, operational pressure, or emerging fragility creates pressure to amend mid-study
Phase D — Post-Readout (After results)
VP question:
Null because biology failed—or because design drifted?
If you don’t do it:
you kill a viable program—or fund the wrong next study.
We deliver:
divergence map + next-step decision options + targeted follow-up tests
Best used:
after a readout that is directionally interesting but decisionally weak
VP question:
Would this hold if rerun—or is it fragile to plausible ranges?
If you don’t do it:
you build strategy on a result that won’t survive scrutiny.
We deliver:
consistency metrics + sensitivity notes + audit-ready rerun report
Best used:
before strategy reset, external review, or major next-step commitment based on the readout
VP question:
What unmodeled factor most likely shaped the outcome?
If you don’t do it:
the next study repeats the same blind spot at higher cost.
We deliver:
candidate confounders list + testable next-step plan (not speculation)
Best used:
after unexpected divergence, unexplained inconsistency, or a result that does not fit the base logic
Phase E — Asset (Reuse / Continuity)
VP question:
Can this logic be audited, reused, and transferred—or is it tribal knowledge?
If you don’t do it:
the program becomes person-dependent, drift-prone, and difficult to review over time.
We deliver:
versioned reproducible package + assumptions log + audit trail
Best used:
when continuity, handoff quality, or portfolio-level reuse matters
Protocol integrity as an auditable asset
We translate protocol logic into explicit, inspectable structures—so risk becomes visible, decisions become clearer, and governance becomes more defensible.
Ranked Protocol Risk Register (Decision Impact–Linked)
- Prioritized fragility points
- Severity rationale
- Minimum Fix Set (highest-leverage changes)
Decision Thresholds & Gate Criteria
- Go/No-Go logic grounded in explicit assumptions
- Sensitivity to real-world variance
- Clear “what must be true” conditions
Transferable Audit Artifacts
- I/O logic contracts, scenario definitions
- Code & tests (when applicable)
- Built to be shared in governance, diligence, and handoffs
Independent • Inspectable • Method-focused
Best for:
fast IC-screen review before deeper diligence
Outputs:
- 1-page Protocol Risk Register (MRR-lite)
- Milestone risk snapshot
- Short board-forwardable note
Includes:
- first-break analysis
- milestone exposure scan
- high-level ambiguity / drift check
Best when: you need a fast view on whether the current discussion is missing fragility that should be visible before commitment
Best for:
upcoming capital, milestone, or board decisions
Outputs:
- Protocol Risk Register (MRR)
- Milestone Fragility Map
- Board-ready Decision Note
Includes:
- focused scenario stress tests
- explicit decision thresholds
- minimum fix set
Best when: interpretability and defensibility need to hold under scrutiny—not just in the base-case plan
Best for:
high-stakes, late-stage, multi-party, or ambiguity-sensitive programs
Outputs:
- full assumptions map + scenario pack
- explicit conviction-flip thresholds
- reusable audit asset (documentation / code when applicable)
Includes:
- expanded scenario coverage
- audit trail for partner / board / governance handoff
- transferable artifacts for continuity and reuse
Best when: ambiguity is costly enough that protocol logic needs to hold as infrastructure, not commentary
Inspect our math
Public, versioned artifacts—reviewable by peers. See de-identified examples on Zenodo and accompanying GitHub repositories. Outputs are delivered in research-grade formats (LaTeX/PDF), suitable for review, forwarding, and audit trails—not marketing decks.
Before your next IC discussion, make the protocol decision-ready.
If you are evaluating a milestone decision, Stage-0 is the fastest way to identify the audit path, the fragility points that matter now, and the questions that need to be visible before commitment.
Governance triage only—not fundraising. Method-focused, forwardable, and built for decision workflows.
Stage-0 is the first gate in our governance audit process. It makes protocol assumptions visible before capital is committed.