PUBLIC TOOLKIT

Tools & Diagnostics for decisions that must hold.

Short, practical diagnostics for clinical-development decisions where uncertainty, design weakness or execution drift can become expensive if they are recognised too late.

Public versions. These tools are designed to expose material questions and escalation triggers. They do not publish the full MB&P consulting method or replace programme-specific medical, statistical, regulatory, operational or legal analysis.

DESIGN & ARCHITECTURE

Before the protocol hardens.

Expose missing decisions before they become amendments, weak comparators or fragile pivotal assumptions.

EVIDENCE & COMPARABILITY

Before the analysis persuades you.

Test whether external, historical or ultra-rare evidence can support a decision that will survive scrutiny.

EXECUTION & RECOVERY

Before delay becomes the headline.

Detect operational drift and distinguish asset failure from a trial that failed to test the asset cleanly.

HOW TO USE THE PUBLIC TOOLKIT

A fast screen. Not a substitute for judgment.

Each diagnostic is intentionally short. Use it to identify whether a decision is supported by evidence or by assumptions that have not yet been tested.

01

Answer the questions

Use the tool with the people who own the evidence and the decision.

02

Score honestly

Classify the relevant domains Green, Amber or Red.

03

Escalate material gaps

Any Red item, or three or more Amber items, warrants structured review before the next irreversible decision.

04

Act proportionately

Use the smallest senior intervention capable of changing the decision.

THE PUBLIC TOOLKIT

Choose the decision you need to stress-test.

Eight public diagnostics are organised around three failure zones: development architecture, comparative evidence and execution / recovery.

DEVELOPMENT ARCHITECTURE

Before design assumptions become expensive.

PRE-PROTOCOL

Clinical Development Concept Completeness Check

A pre-protocol diagnostic to expose missing decisions before a concept sheet is mistaken for a development plan.

Use when: the team has detail, but the development decision, evidence threshold or next value gate is still unclear.

PRE-FPI

Protocol Amendment Risk Check

A pre-FPI diagnostic to identify design assumptions most likely to become expensive amendments later.

Use when: eligibility, patient burden, endpoint variability, recruitment assumptions, vendors or logistics could force redesign after FPI.

PIVOTAL DESIGN

Pivotal Architecture Decision Grid

A board-level comparison of pivotal evidence architectures before a preferred design becomes organisationally irreversible.

Use when: single-arm, randomised, hybrid or external-control options carry materially different regulatory, HTA, timeline or capital consequences.

COMPARATIVE EVIDENCE

Before external evidence becomes a claim.

CAUSAL CREDIBILITY

Causal
Proof Check

A diagnostic for deciding whether an external or historical comparison is credible enough to support a serious development decision.

Use when: a favourable conclusion depends on comparability, overlap, measured prognostic factors, sensitivity to hidden bias and reproducibility.

DATA READINESS

External
Comparator Preflight

A pre-analysis check to determine whether an external comparator is trial-like enough to justify further work.

Use when: data provenance, trial alignment, covariate completeness, common support or calendar-time differences may undermine the comparison.

RARE DISEASE

Ultra-Rare Comparative Evidence Check

A design diagnostic for tiny populations where ethics, evidence strength and patient efficiency must be solved together.

Use when: the programme is relying on rarity as the justification for weak comparison rather than maximising credible information per participant.

EXECUTION & RECOVERY

Before drift becomes delay — or a negative result becomes a false conclusion.

LIVE TRIAL

Trial Execution Early-Warning Check

A simple diagnostic for detecting whether sites, patients and data are drifting before the headline milestones show the delay.

Use when: activated sites, patient funnel, data flow, decision latency or forecast credibility are beginning to diverge.

INTERACTIVE · 3-MINUTE QUICKCHECK

Trial Autopsy — Failure Signal Check

A board-level diagnostic to distinguish a disappointing result from an uninterpretable test of the asset.

Use when: biology, exposure, population, endpoint, execution and statistical interpretability cannot yet be separated cleanly.

RELATED ONLINE DECISION FRAMEWORK

Should you replace the CRO — or rescue the operating model?

A sponsor-side decision framework for recruitment delay, governance failure, CRO underperformance and deciding between remediation, targeted replacement and a full CRO transition.

PUBLIC VERSION

Enough to expose the question.
Not enough to replace programme-specific analysis.

The downloadable PDFs are deliberately concise. If a diagnostic exposes a material gap, the next step should be proportionate: independent review, design comparison, trial autopsy, governance reset or a bounded work package.

FROM TOOL TO DECISION

Use the result where the decision is actually being made.

Clinical Development Strategy

Architecture, endpoints, comparator, population and evidence strategy.

Trial Rescue & Execution Governance

Feasibility, recruitment, operational control, governance and recovery.

Results & Case Studies

See how similar decision patterns appear in real programmes.

A DECISION AHEAD?

What decision cannot afford to be wrong?

Bring one live decision, the next hard milestone and what is currently exposed.