Focused engagements for teams designing — or evaluating — interventional research. All assessments are delivered under appropriate confidentiality.
Each engagement applies the same Temporal Design Analysis framework, calibrated for the decision in front of you — from first-in-human study design through investor diligence on a clinical-stage asset.
Phase 2 and Phase 3 protocols are where temporal design mistakes become expensive. A misaligned measurement schedule can't be fixed after enrollment begins, and amendments carry significant cost and delay. Yet most protocols are still designed around operational convenience rather than biological timescales.
Temporal Design Analysis evaluates individual protocols against the largest validated database of clinical trial design quality — 275,000 interventional trials with outcome linkage. For sponsors in competitive indications, a comparative review places the protocol against the de-identified aggregate distribution of trials in the same space — success-rate benchmarks and design-quality percentiles drawn from history that no single-protocol assessment can provide, without naming or scoring any other sponsor's trial.
Not ready for a full assessment? See the Endpoint & Timing Alignment Review — one question, from $2,500.
Life science investors face a recurring problem during clinical-stage diligence: the protocol is the product, but protocol design quality is rarely examined. A trial's measurement architecture strongly influences whether it will generate interpretable data — and that architecture can be assessed on the specific asset you're evaluating.
Temporal Design Analysis gives investors a third-party read on the temporal design quality of the asset under diligence: an overall score with a breakdown of where the design is strong or exposed, benchmarked against the de-identified aggregate distribution of historical trials in the same indication. We score the trial you're evaluating — or compare it to anonymized cohort benchmarks — rather than producing unsolicited assessments of other sponsors.
For diligence on a specific opportunity, and for portfolio companies reviewing their own protocols. More ambitious portfolio-scale and multi-asset analyses are scoped individually.
You carry the outcome without controlling the design. When a return resolves on a single readout rather than a portfolio, the protocol's measurement timing becomes a credit exposure — and it is rarely examined during diligence.
Independent, pre-execution review of measurement timing in Phase 2 and Phase 3 protocols, structured for positions where the sponsor is not our client.
FDA's Project Optimus guidance and the ICH E20 draft on adaptive designs have raised the bar for Phase 1. Sponsors are now expected to generate exposure-response data rich enough to support optimal biological dose selection — not just maximum tolerated dose. Many Phase 1 protocols still use sampling architectures designed for the older paradigm.
For translational and early-clinical leads, the question is increasingly whether a Phase 1 design will produce a dose decision the Phase 2 team can actually defend — and whether that case can be made before the IND is locked.
Temporal Design Analysis evaluates whether a Phase 1 design captures the PK/PD temporal architecture needed to inform Phase 2, with optional alignment notes referencing current FDA and ICH guidance.
Not ready for a full assessment? See the Endpoint & Timing Alignment Review — one question, from $2,500.
Is your primary endpoint being measured at the right time relative to the biology it’s meant to capture? A narrower, faster check than a full protocol review, giving you a single defensible read on whether your measurement schedule is positioned to catch the signal that matters.
The question is whether your sampling and observation windows are placed to produce a dose decision the Phase 2 team can actually defend. With FDA’s Project Optimus raising the bar beyond maximum tolerated dose toward optimal biological dose, a Phase 1 design now has to generate exposure-response evidence rich enough to justify the dose it carries forward. We assess whether your PK/PD sampling schedule and DLT observation window are timed to capture that evidence — before the IND locks.
The endpoint is usually already chosen; the risk is when it is read. A primary endpoint assessed on a convenience schedule rather than when the biology actually moves can miss a real effect entirely — the familiar pattern being a mechanism that activates early but is judged at a timepoint set for clinic logistics. We assess whether your efficacy readout lands when the underlying mechanism is actually detectable, and flag where the calendar and the biology have drifted apart.
The Temporal Design Score methodology and related applications are the subject of pending U.S. provisional patent applications owned by Scientari LLC.
Whichever offering you choose, the deliverable is a short, decision-ready PDF — typically 12 to 18 pages — that your clinical, biostatistics, and translational leads can read in one sitting and act on in the next protocol revision. Written by a trained analyst, not generated and shipped.
Your protocol's overall temporal design score, positioned against the indication-matched cohort from our 275,000-trial retrospective database. You see where you land relative to historical successes and failures in your therapeutic area — with a breakdown of how your protocol performs across the framework's core dimensions and the specific design decisions driving each.
The specific measurement-timing decisions in your current protocol that are most likely to undermine your ability to detect or interpret signal. Ranked by impact, with cohort-level evidence behind each.
Concrete protocol changes, ranked by impact and cost. Most recommendations re-allocate samples or assays you're already collecting; few require new patient visits. Each is mapped to the gap it closes.
An estimate of whether your protocol's design pattern is likely to require a substantial amendment after enrollment opens — calibrated against the amendment history of trials with similar temporal profiles.
Our retrospective analysis shows a strong, consistent association between temporal design quality and trial outcomes. The next phase is prospective — confirming that advantage carries forward on live protocols. We work with a select group of qualifying Phase 2 sponsors to do exactly that. Engagement terms are discussed directly after inquiry.
A full-protocol Temporal Design Analysis of a live study — the complete diagnostic assessment, stepwise burden triage, indication benchmarking, and cost modeling — delivered by a trained analyst.
Implementation of the priority recommendations we identify, and agreement to share de-identified outcome data at trial completion. We are particularly interested in Phase 2 oncology and immunology programs.
Does acting on our analysis change a trial's outcome? We have strong reason to believe it does — and this program builds the prospective evidence to demonstrate it definitively.
Tell us about the program you'd like reviewed — Phase 1, Phase 2/3, or portfolio diligence — and we'll follow up to discuss fit.
All inquiries handled under appropriate confidentiality.
Temporal Design Analysis is a product of Scientari LLC, based in Encinitas, California. Trial Readiness is the platform; Temporal Design Score is its founding technology, with additional clinical trial intelligence systems under development. Our methodology is grounded in established optimization frameworks (Design of Experiments, Response Surface Methodology) applied to biological timescale design. The Temporal Design Score methodology and related applications are the subject of pending U.S. provisional patent applications owned by Scientari LLC.