Pre-Launch — Early Access Now Open

Your trial's temporal design is a measurable risk factor.

Temporal Readiness Analysis scores clinical trial protocols on a 0–40 scale — quantifying the risk that measurement timing misaligns with the biology you're trying to measure. Informed by a 275,000-trial retrospective analysis. Methods paper in preparation.

275K
Trials Analyzed
Complete ClinicalTrials.gov database
Success Rate Association
Trials with trajectory modeling capability
10
Indications Tested
Association replicates across every area

Phase 2 trials fail at alarming rates. A hidden contributor: temporal design.

Most protocols set measurement timepoints based on convention — patient visit schedules, historical precedent, operational convenience. Not biology. When measurements miss the mechanistic window, trials generate data that can't distinguish a failed drug from a failed design.

Excellent translational teams already think about measurement timing intuitively. TRS makes this evaluation systematic, reproducible, and benchmarked — ensuring that institutional knowledge doesn't walk out the door when team members rotate.

In our retrospective analysis, 97% of failed trials in CNS, immunology, and cardiovascular indications scored below TRS 20 — well beneath the competitive threshold. These aren't exotic failures. They're design gaps identifiable before enrollment.
69%
Phase 2 failure rate, all indications1
93%
Phase 1-to-approval failure, oncology2
Oncology Phase 276% fail rate1
CNS / Neurology84% fail rate1
Cardiovascular79% fail rate1
Immunology81% fail rate1

What a TRS assessment reveals

Two oncology trials from our retrospective database. One succeeded with strong temporal design. One failed with identifiable gaps.

Success
32/40

Combination IO Trial — Endometrial Cancer

Phase 2 · 120 patients

What strong temporal design looks like

Early immune activation measured within the first week. Multi-scale coverage from cellular signaling through imaging. Biomarker velocity tracked monthly. Individual patient trajectories modeled.

Failed
13/40

IO Monotherapy Trial — Urothelial Carcinoma

Phase 3 · 931 patients

Gaps a TRS assessment would have flagged

Single endpoint at Week 12 with no early mechanistic data. No biomarker velocity tracking. Group-level analysis only. A TRS assessment would have identified specific low-cost additions.

See detailed evidence, methodology, and full indication-level data →

Actionable intelligence, not another dashboard

Answer a structured questionnaire about your study's measurement schedule — no protocol submission required. Receive a scored assessment with specific, costed recommendations. Delivered in two weeks.

A

Protocol Assessment

Your protocol scored on a 0–40 scale across four temporal design components. Benchmarked against your indication and phase from the 275K-trial retrospective database.

R

Risk Quantification

Specific temporal gaps identified — missing mechanistic windows, insufficient sampling density, unresolved rate-of-change — with risk estimates based on retrospective associations in the database.

O

Optimization Roadmap

Concrete recommendations prioritized by impact-per-dollar. Full-protocol engagements include stepwise triage: Tier 1 (zero additional patient burden), Tier 2 (moderate), and Tier 3 (new visit windows) — so you implement only what fits your operational constraints.

$

ROI & Cost Modeling

Location-adjusted cost estimates for every recommendation. Per-patient incremental cost as a percentage of your existing execution budget, with estimated failure-cost-avoidance projections.

Who benefits most

Heads of Clinical Development

De-risk Phase 2 go/no-go decisions with quantitative temporal design evidence before committing enrollment budget.

Biotech Founders & CEOs

First Phase 2 trial is often make-or-break. A TRS assessment costs less than one week of enrollment delay — and identifies the design flaws that cause preventable failures.

Translational Science Leads

Design multi-scale measurement cascades that generate interpretable mechanism-of-action data, not just endpoint readouts.

Get early access to Temporal Readiness Analysis

Sign up and we'll reach out within 48 hours to discuss your program and determine which assessment pathway fits best.

No commitment required. We'll reach out within 48 hours.

Temporal Readiness Analysis is a product of Scientari LLC, based in Encinitas, California. Our methodology is grounded in established optimization frameworks (Design of Experiments, Response Surface Methodology) applied to biological timescale design.

1 BIO/Informa/QLS 2022. 2 Wong et al., Biostatistics 2019. 3 Schuhmacher et al., Drug Discovery Today 2025. TRS data: Scientari LLC retrospective analysis, 275K trials. Full references →