Temporal Design Analysis assesses whether a protocol's measurement timing is positioned to detect the effect it's meant to measure. Informed by a 275,000-trial retrospective analysis.
Trial Readiness reviews a clinical trial protocol and tells you how well its measurement timing matches the biology it's trying to capture, benchmarked against comparable trials in the same indication. Trials that miss the biological window can spend years and millions producing data that can't tell a failed drug from a failed design. We help you find those gaps while they're still cheap to fix.
Anything from a public ClinicalTrials.gov listing to a fully-furnished draft protocol under NDA. We tell you up front what level of detail produces what level of answer.
Your protocol is rated for temporal design quality, then benchmarked against the indication-matched cohort from our retrospective database. A trained analyst reviews every score before it leaves.
A short, decision-ready document: your overall TDS score, a breakdown of where the design is strong or weak, the specific design gaps we found, and prioritized recommendations — most of which re-allocate samples you're already collecting rather than adding new visits.
Every engagement includes a written analyst review of your protocol. You get the diagnosis and the recommendations, explained in terms of your own design.
Curious what the score looks at? See the design questions we evaluate →
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. TDS makes this evaluation systematic, reproducible, and benchmarked — ensuring that institutional knowledge doesn't walk out the door when team members rotate.
Two oncology trials from our retrospective database, shown to illustrate what the analysis surfaces. These are examples of strong and weak temporal design, not evidence that design quality determined either outcome.
Early immune activation measured within the first week. Multi-scale coverage from cellular signaling through imaging. Biomarker velocity tracked monthly. Individual patient trajectories modeled.
Single endpoint at Week 12 with no early mechanistic data. No biomarker velocity tracking. Group-level analysis only. A TDS assessment would have identified specific low-cost additions.
See detailed evidence, methodology, and full indication-level data →
Temporal design problems don't show up in a slide deck. They show up as questions you can't fully answer when the program lead asks why a timepoint is where it is, as amendments after enrollment opens, as data that's hard to interpret at interim, and as a CRO scope of work that's already locked. We built Temporal Design Analysis for the people on the hook for those answers.
You own the question of whether this protocol can actually answer the scientific question — and you'd rather have that conversation before the IND is locked than after the interim. A TDS assessment gives you an independent, benchmarked read on temporal design before you commit to the schedule of assessments.
Amendments are the single most expensive form of "we should have caught that earlier." Temporal design gaps are one of the few amendment drivers that are visible at design time — if you know where to look. We help you look.
You already think about measurement timing intuitively. TDS gives you a systematic, benchmarked second opinion you can bring into a protocol meeting — one that doesn't depend on which biostatistician happens to be in the room.
When you're evaluating a Phase 2 asset, the protocol is the bet. A TDS readout gives you a third-party view of whether that trial's measurement architecture is set up to read out cleanly — scored on the asset you're diligencing and benchmarked against de-identified historical cohorts, not against other sponsors by name.
Most TDS-driven recommendations re-allocate samples you're already collecting or add cheap analyses to draws you're already taking. Few require new patient visits. The point is not to make the trial bigger — it's to make the data answerable.
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. Engagements are most useful before protocol lock, but a readout against a finalized protocol still surfaces gaps worth knowing about before enrollment opens.
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.