Signal Resilience · Design-partner projects

Before you build the next trial around a signal, find out what survives scrutiny.

Signal Resilience stress-tests one pre-specified early-phase efficacy signal across plausible analytical assumptions, showing where the conclusion persists, where it weakens, where it collapses and what evidence would most change confidence.

Discuss a signal Explore SR-0001

Why it matters

One early result can carry a very large decision.

A Phase I/II efficacy signal can influence an expansion cohort, biomarker strategy, Phase II design, licensing discussion or investment decision.

Before that result carries more patients, time and capital, the question is not only whether the signal is promising, but how dependent the development conclusion is on the analytical choices behind it.

01
Does the conclusion persist across plausible analytical specifications?
02
Which assumptions materially weaken or change the interpretation?
03
What additional evidence would most change confidence before the next decision?

The principle

Robustness is not the same as a compelling headline result.

Signal Resilience examines how the magnitude and uncertainty of one pre-specified signal change across plausible analytical specifications.

For each engagement, the relevant specifications and descriptive decision criteria are documented before the sensitivity-analysis results are examined.

Analytical resilience does not guarantee clinical replication.

We test the signal you bring. We do not search for a better story.

The purpose is to stress-test a pre-specified development claim, not to search the dataset after the fact for a more attractive subgroup, cut-off or narrative.

Pre-specifiedSpecifications are documented before sensitivity-analysis results are examined.
ReproducibleVersioned code and data snapshots support reproducibility, and every reported figure can be regenerated.

ILLUSTRATIVE ANALYSIS · SYNTHETIC DATA · FICTIONAL SPONSOR

SR-0001

A signal can look very different once its assumptions are tested.

VerdictFRAGILE

Difference in objective response rate, X-score-high minus X-score-low · percentage points · 95% CI

Original signal

10% cut-off

+20 pp

+1 to +41 Reported

Confirmed responses only

+7 pp

−9 to +25 Collapses

5% cut-off

+1 pp

−21 to +18 Collapses

15% cut-off

+3 pp

−17 to +30 Collapses

20% cut-off

Only 6 patients met the ≥20% cut-off.

+21 pp

−15 to +67 Uninformative

X-score-evaluable treated population

non-evaluable response counted as non-response

+19 pp

+1 to +38 Persists

11 / 192

specifications with 95% CIs entirely above zero · 5.7%

At the reported 10% cut-off, all 48 specifications had a positive ORR point estimate. Across all cut-offs, 141 of 192 did. The magnitude used to justify enrichment was not supported.

Explore SR-0001

A resilient result is also a finding. It can strengthen confidence in the analytical robustness of the development case presented to boards, partners and investors.

What you receive

Signal Resilience Map

A decision-focused view of how one pre-specified signal behaves when its analytical assumptions are stress-tested.

What persists

Where the signal remains comparatively stable under the pre-specified resilience criteria.

What weakens

Where plausible analytical choices materially reduce the observed signal.

What collapses

Where the observed effect falls below the pre-specified descriptive collapse criterion.

What matters next

The additional evidence that would most reduce decision-relevant uncertainty.

Uninformative marks specifications where the available evidence does not support a meaningful resilience classification.

Decision points

Useful before one signal becomes a larger commitment.

Before Phase II or expansion

When one early efficacy signal is about to drive a larger trial commitment.

Before biomarker enrichment

When a cut-off or subgroup is shaping the next development strategy.

Before partnering or licensing

When the resilience of the efficacy story matters to valuation or deal discussions.

During investment diligence

When an investor needs to understand how dependent an early clinical claim is on analytical assumptions.

Engagement

One signal. Defined scope. Decision-focused output.

Currently available through selected design-partner engagements.

You provide
Patient-level data, protocol, SAP and one pre-specified efficacy signal.
We agree
The signal, analytical scope, required inputs, timing, deliverable and fee before analysis begins.
We deliver
A Signal Resilience Map showing what persists, what weakens, what collapses and what evidence matters next.

7–10 business days from a clean dataset, depending on complexity
One pre-specified signal
Fixed scope
NDA · data processing agreement where applicable

For oncology development teams

Stress-test the signal before it drives the next trial.

For teams with a pre-specified early efficacy signal approaching expansion, Phase II, biomarker enrichment or another consequential development decision.

Discuss a signal

For investors & business development

Find out how much of the clinical story survives scrutiny.

Independent assessment of a pre-specified early efficacy signal for investment, partnering or licensing diligence.

Patient-level analysis requires appropriate access to the underlying data through the sponsor.