Four focused offerings for teams designing — or evaluating — interventional research. All assessments are currently in early access, under appropriate confidentiality.
Retrospective analysis shows a strong association. The next step is prospective evidence. We're offering complimentary deep TDS analysis to a limited number of qualifying sponsors. Sponsors with confidentiality constraints or urgent timelines can move directly to a paid engagement below — this program is for forward-looking validation partners, not a prerequisite.
A full-protocol TDS assessment, including component-level scoring, stepwise triage, indication benchmarking, and cost modeling — provided at no cost to qualifying partners in exchange for prospective outcome sharing.
Implementation of at least two Tier 1 or Tier 2 recommendations, and agreement to share de-identified outcome data at trial completion. Particularly interested in Phase 2 oncology and immunology trials.
"Has improving a TDS score ever changed a trial outcome?" We believe it has — but belief isn't evidence. This program creates the prospective dataset to answer that question definitively.
Each engagement applies the same Temporal Design Analysis framework, calibrated for the decision in front of you — from preclinical 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.
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.
Preclinical protocols carry temporal assumptions that are rarely examined — nocturnal activity cycles in rodents, narrow collection windows across large cohorts, satellite versus serial sampling tradeoffs, and washout periods in reused animals. Small misalignments at this stage propagate into noisier IND packages and weaker Phase 1 hypotheses.
Temporal Design Analysis brings the framework validated across 275,000 clinical trials to the design stage of preclinical work, adapted for species-specific biology and study archetypes.
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: a TDS score with component breakdown, 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.
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 score on the 0–40 scale, 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.
Independent scores for Temporal Alignment, Coverage, Extensibility, and Velocity — with the specific protocol decisions that drove each score. This is where the diagnosis happens.
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 component pattern is likely to require a substantial amendment after enrollment opens — calibrated against the amendment history of trials that scored similarly.
The analyst who prepared your report walks your team through the findings, takes questions, and clarifies any recommendation you'd like to push back on. One round of follow-up questions is included.
Tell us about the program you'd like reviewed — preclinical, 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.