Bayes Pharma.ai Global Trial Intelligence
KEYNOTE-407 · pembrolizumab · NSCLC
Decision overview
Current readiness across evidence review, source confidence, endpoint strategy, decision language, and package preparation.
Gold-standard command center
One view for evidence family, source strength, reviewer gates, package status, and next action.
Recommended next steps
Actions needed before this evidence family is used for important decisions.
Evidence position
Decision-focused interpretation for the selected evidence family.
Endpoint strategy snapshot
Endpoint clarity by outcome, including gaps that require protocol or source confirmation.
Evidence families
Find and open evidence families for the selected asset and disease context.
Evidence review
Review every evidence value against the source. Mark values as checked, corrected, rejected, ready, or locked.
Source confidence
Shows whether evidence is supported by publications, trial registries, labels, or reviewer-confirmed source notes.
Source confidence by endpoint
Publication-only evidence should remain limited until supported by registry, label, or reviewer-confirmed source notes.
Add reviewer note
Use this when a reviewer confirms a source or adds scientific context.
Global registry coverage
Duplicate-safe coverage across ClinicalTrials.gov, EU CTIS, EU CTR/EudraCT legacy, and WHO ICTRP. WHO mirrors are shown as coverage support, not independent evidence.
Duplicate-safe registry matrix
Primary registries can support confidence; WHO ICTRP is treated as aggregator coverage unless no original registry is available.
Endpoint strategy
Clarifies what each endpoint means, which population it applies to, how it was measured, and what gaps remain before protocol or decision use.
Decision language
Check whether proposed wording is appropriate for internal discussion, partner communication, or external-facing materials based on the current evidence status.
Review decision language
Overstated wording is flagged until supporting evidence has been reviewed and the package is finalized.
Suggested wording
Evidence-based wording generated from the current review status.
Endpoint evidence
Endpoint outcomes with confidence intervals, treatment arms, source evidence, and review status.
Evidence pathway
Follow how source evidence becomes an endpoint outcome, a reviewed decision statement, and a versioned decision package.
Comparator summary
Separate treatment comparators from endpoint result contrasts, and keep same-family HR summaries clearly exploratory.
Comparator context
Only true treatment/control arms should be interpreted as comparator context.
Exploratory evidence summary
Same-family follow-up summaries are exploratory and should not be presented as independent meta-analysis.
Evidence review project
Create an evidence review project, define ownership, and track reviewer roles before sign-off and package finalization.
Review project setup
Use this to create a reusable review record for the current evidence family.
Evidence projects
Open review projects for the current environment.
Decision package
Prepare, sign off, finalize, and export a stable decision package with evidence review, source confidence, endpoint strategy, decision language, and fingerprint.
Decision package contents
Package readiness, evidence fingerprint, and required next actions.
Reviewer sign-off
Record review decisions by role.
Decision audit
Track who reviewed what, when it changed, why it changed, and whether it is suitable for decision use.
Evidence readiness
Operational validation view showing source-confidence performance, review completion, demo-finalization progress, and recorded validation metrics.
Validation summary
Use this to track whether the evidence workflow is ready for client demonstration and market validation.
Recorded validation metrics
Manual or reviewer-recorded accuracy and quality metrics.
Evidence updates
Track whether the evidence family has changed after a decision package is prepared.
Disease-specific templates
Disease-specific evidence expectations and curated public examples for demonstrations, validation, and reviewer training.
Disease-specific templates
Endpoint and comparator expectations by disease context.
Curated examples
Public examples to review, finalize, and use for demonstration.
Preview mode
A clean executive preview for discussions, mobile viewing, and decision meetings.
Trial identity graph
Connect evidence family, registries, publications, labels, regulatory support, and endpoint atoms into one traceable identity graph.
Identity nodes
Trial family, IDs, sources, endpoints, and labels.
Evidence relationships
Edges that explain how source evidence supports claims.
Claim-grade evidence compiler
Endpoint-by-endpoint claim cards with source trail, reviewer gate, allowed wording, and blocked wording.
Endpoint claim cards
Each card should be understandable by clinical, regulatory, and medical teams.
Language controls
Allowed, cautious, and blocked wording for package use.
Reviewer signoff
Endpoint-level scientific signoff for reviewed, ready, and locked evidence packages.
Endpoint signoff template
Required endpoints and checklist completeness.
Signoff form
Writes auditable endpoint review events.
Reviewer package status
Reviewed, ready, locked, and external-use state.
Enterprise trust
Completion card for reviewed evidence scope, audit events, required controls, and package readiness.
Completion status
Decision-ready within the reviewed evidence scope.
Required controls
Controls supporting the current completion state.
System coverage
Checks whether each gold-standard workspace feature is connected to a live backend endpoint.
🏆 Gold‑Standard Validation Dashboard
Real‑time precision and recall scores for all validated evidence families. 1.0 = Perfect Score
Validated Families
Precision/Recall scores for each goldset family
Add New Validation Family
Add a new family to the goldset and validate it instantly
Reports and sharing
Generate evidence briefs, review tables, package JSON, markdown, and sharing outputs.
Evidence report
Rendered evidence report.
Report actions
Download or copy current review state.
🔬 Protocol Similarity Engine
Find similar clinical trials, benchmark designs, and predict trial success based on historical patterns.
⚔️ Asset Battlecards
Competitive intelligence: Side-by-side comparison of pharmaceutical assets and competitive landscape analysis.
⚠️ Evidence Contradiction Engine
Detect discrepancies across Publication, Registry, and Label sources. Identify potential contradictions before they impact decisions.
🏢 Executive Command Center
Portfolio dashboard showing all assets with scores, risks, and upcoming catalysts.
Asset Portfolio
Click any row for detailed view
Add Asset to Portfolio
🏷️ Label Change Monitor
Track regulatory label changes from FDA, EMA, and PMDA. Stay informed about updates to approved indications.
📉 Protocol Failure Prediction
Estimate enrollment, dropout, endpoint, and approval risks for your trial design.
📋 Regulatory Evidence Gap Engine
Identify missing evidence for regulatory approval, analyze submission readiness, and generate actionable gap-filling plans.
🔄 Endpoint Drift Detection
Track endpoint evolution from protocol → publication → conference → label. Detect changes and inconsistencies.
📦 System of Record
Immutable evidence storage with full versioning, audit trails, and evidence freeze capabilities.
📦 Evidence Records
🧠 AI Evidence Copilot
Ask natural language questions about your evidence. Powered by Knowledge Graph and AI.
Quick Questions
📋 Regulatory Submission Generator
Generate submission-ready regulatory packages for FDA, EMA, and PMDA. Auto-generate cover letters, evidence summaries, and clinical trial information.
📊 Portfolio Optimization Engine
AI-driven portfolio strategy recommendations based on asset scores, risks, and catalysts.
💰 Evidence-Based Pricing Engine
Value-based pricing recommendations based on clinical evidence, competitor pricing, and unmet need.
📄 Automated Evidence Reports
Generate executive-ready reports: Board briefs, investor reports, regulatory updates, and competitive briefs.
🌍 Real-World Evidence (RWE) Integration
Connect clinical trial evidence with real-world data for validation, comparative effectiveness, and patient population insights.
📐 Trial Design Optimizer
AI-powered recommendations for optimal trial design: sample size, endpoints, patient population, and statistical power analysis.
💊 Drug Repositioning Engine
Identify new indications for existing drugs based on evidence, mechanism of action, and competitive landscape.
🧬 Patient Population Discovery
Identify biomarker-defined patient subgroups for precision medicine and personalized treatment strategies.
⚖️ Regulatory Strategy Advisor
Get regulatory pathway recommendations, accelerated approval eligibility, and timeline estimates.
📊 Market Research Engine
AI-powered market research reports with multi-agent system. Generate executive summaries, detailed reports, and competitive intelligence.