Independent, pre-execution review of measurement timing in Phase 2 and Phase 3 protocols — for lenders, royalty and milestone holders, and co-development capital whose return resolves on a single readout rather than a portfolio.
Equity investors diversify across a portfolio and hold governance rights. Non-equity capital does neither. The economics are contractual, contingent on a specific trial, and the design of that trial was settled by someone else before the paper was signed.
Facilities to clinical-stage borrowers are routinely sized and tranched against a clinical readout. When a design flaw forces a substantial amendment, the consequence lands as unplanned burn against a facility that was underwritten on a different assumption — and an uninterpretable readout is a credit event, not a scientific disappointment.
The question we answer: is this protocol’s measurement schedule positioned to produce an interpretable result on the timeline the facility assumes?
Underwriting a development-stage stream means pricing a probability of success, and that number is almost always drawn from historical base rates by phase and indication. Those tables have no way to separate a well-timed protocol from a poorly timed one in the same indication — the design difference is invisible to the model that prices the deal.
The question we answer: does the design of this specific trial argue for adjusting the probability you have assumed?
When capital is committed to a named study rather than a company, the return does not average out across a book. It resolves on whether that one trial produces a readable answer. You wrote the cheque; the sponsor wrote the schedule of assessments; you carry the consequence of the gap between the two.
The question we answer: is the study you are funding designed to give the underlying science a fair test?
Scientific diligence reliably examines mechanism, competitive position, enrollment feasibility and endpoint selection. What it seldom examines is when the biological readouts are scheduled to occur, relative to when the mechanism under test is actually active and detectable.
A primary readout placed on a convenience schedule rather than a biological one can miss a real effect entirely. The failure mode is quiet: the trial runs to completion, the data are clean, and the answer is uninterpretable — or negative for reasons that have nothing to do with the drug.
It is also a decision that is effectively free to change before first-patient-in and expensive afterwards. Roughly three-quarters of trials are amended at least once, at a median direct cost of $141,000 for a substantial Phase 2 amendment and $535,000 in Phase 3 (Tufts CSDD). HHS has cited approximately 45% of protocol amendments as avoidable (Operation TrialBlazer, 2026).
Our retrospective work across a large database of interventional trials with outcome linkage finds temporal design quality to be strongly and consistently associated with trial outcomes, across regions, indications and sponsor types. The evidence and methodology are documented here →
We assess protocols for sponsors as well as for the capital behind them. That only works if the boundary is explicit, so it is stated here rather than buried in an engagement letter.
An assessment commissioned by one party is delivered to that party only. We do not resell, recirculate or reference a client’s assessment to anyone else, in any form.
We will not assess a sponsor’s protocol on behalf of a third party while that sponsor is a client of ours. If the check fails, we decline the engagement and say so.
Where the commissioning party does not hold contractual rights to the protocol, the assessment is built from the public registry record. We do not solicit, accept or use confidential protocol material that a party is not entitled to share.
We do not run studies, place patients or hold any position in the asset. There is nothing in our recommendations shaped by what has already been promised to anyone.
Recurring review across the assets underlying a book or fund is priced per asset on an annual basis. Assessment cost is intentionally small relative to the positions it informs.
Request an Assessment →The Temporal Design Score methodology and related applications are the subject of pending U.S. provisional patent applications owned by Scientari LLC.