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Evidara for Clinical Development

Skip the endpoint search.
Build the protocol.

Every clinical trial protocol begins with the same evidence work: endpoint benchmarking, regulatory precedent, and trial landscape analysis. That search takes 2–3 weeks. Evidara completes it in minutes — leaving your team to focus on the protocol design that actually requires scientific judgment.

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All phases
Registered trials for your indication, benchmarked by primary endpoint
Endpoint mix
Primary endpoint usage by phase, with FDA acceptance precedent
FDA+EMA
Regulatory pathway and surrogate endpoint precedent on every Protocol Reg run
21 CFR
Part 11 audit trail on every analysis — submission-grade evidence documentation
The clinical development friction

Two evidence problems that slow
every protocol before it starts.

01 — Endpoint Benchmarking
Finding what FDA accepted in similar trials takes weeks
Understanding which endpoints FDA has accepted as primary in your indication — and what statistical thresholds accompanied approval — requires manual review of FDA briefing documents, published trials, and ClinicalTrials.gov registry data. It takes 2–3 weeks when done manually.
~2–3 weeks per indication landscape
02 — Regulatory Precedent
Accelerated approval pathways require documented precedent
Biomarker-based approval, surrogate endpoint strategy, and accelerated pathways all require documented regulatory precedent from comparable drugs in comparable indications. No single source contains this — requiring manual FDA correspondence review and competitive intelligence.
Missed pathway risk
How Evidara solves it

Three evidence protocols built for
clinical development workflows.

Protocol B — Trial Intelligence

Endpoint landscape in 11 seconds

Chain B extracts endpoint data, trial design parameters, and outcomes across every registered trial in your indication — returning a benchmarked endpoint landscape with FDA precedent, statistical thresholds, and patient population comparators.
Primary and secondary endpoint landscape by phase
FDA acceptance precedent for surrogate endpoints
Patient population and eligibility criteria comparators
Statistical significance thresholds across comparable approvals
Protocol Reg — Regulatory Intelligence

Regulatory pathway analysis and accelerated approval evidence

Chain Reg synthesizes FDA approval history, surrogate endpoint precedents, accelerated approval pathways, and NDA labeling evolution — structured as a regulatory strategy evidence package for pre-IND and Phase 2 planning. FDA and EMA aligned.
Accelerated approval and Breakthrough Therapy precedents
Surrogate endpoint regulatory history in your indication
NDA label precedent and post-marketing commitment trends
EMA vs. FDA approval pathway comparison
Protocol A — Literature Review & Safety Signal

Background evidence and post-marketing safety, deterministically

Chain A runs a deterministic retrieval and safety-signal pipeline, with one small model call for screening and extraction — a measured run costs about $0.02 — returning a sourced evidence base and adverse-event profile for the IND/CTA background section. Cited claims carry their source; anything unsourced is flagged.
Deduplicated literature across the indication, relevance-scored
FAERS adverse event signals and FDA label history
Evidence gaps surfaced against the retrieved set
Deterministic retrieval and scoring, with one small model call — about $0.02 per measured run
Illustrative example

ALS endpoint benchmarking — run live

Chain B benchmarks the endpoint landscape for an indication — retrieving registered trials, summarising which primary endpoints are used at each phase, and cross-referencing the regulatory record for precedent.

Run this analysis yourself →
"What endpoints has FDA accepted in ALS trials over the last decade and what's the regulatory precedent for ALSFRS-R as a primary endpoint surrogate?"
Registered trials retrieved for the indication, with primary endpoint usage summarised
Regulatory precedent surfaced where an endpoint has supported approval as a surrogate
Alternative primary endpoints listed with the trial phases that used them
Endpoint validation literature indexed alongside the regulatory record
EMA aligned with FDA on ALSFRS-R — EMA/CHMP guidance cross-referenced
Chain B · Illustrative example — not a live run · PROVISIONAL, requires expert review
Get started

Run a live endpoint benchmark
on your indication.

We'll run a live analysis on your disease area in the demo — using your own question against live endpoint data from ClinicalTrials.gov, FDA records, and literature.

Request a Demo → Explore free →