Validated Intelligence for Biomedical Decisions
Evidence packs that turn public clinical and regulatory evidence into cited, structured reports for drug development, clinical strategy, and regulatory decision-making. Drafted in minutes and built for expert review.
What is an Evidence Pack?
Evidence Packs are modular AI intelligence products. Each one combines the evidence sources, domain context, and report structure needed to answer a specific class of biomedical question with cited, reviewable outputs.
Curated Evidence Bundles
Each pack combines curated evidence sources, a domain-specific analysis approach, and a structured report format built for a specific biomedical question.
Domain-Specific Reasoning
Each pack carries domain-specific instructions and its own evidence retrieval strategy. Multi-step agent pipelines are in development.
Structured, Reviewable Outputs
Every report includes numbered citations, evidence-support indicators for each section, and flagged gaps. Reports are drafts that require qualified human review.
Minutes, Not Months
Evidence synthesis that previously required weeks of manual literature review is drafted in minutes, ready for expert review.
Why Generic AI Isn't Enough
General-purpose language models were not designed for the evidentiary standards of drug development. EvidencePack.bio is built to narrow the gap between AI capability and regulatory expectation.
Generic AI hallucinates citations
Reports cite numbered source passages retrieved from trial registries, publications, and FDA records, so reviewers can check each statement against its source.
Chat outputs lack structure
Packs produce structured reports: an executive summary, analysis sections, key evidence, risks and gaps, and recommended next actions.
Confidence with no basis
Each section shows how strongly its cited sources match the question, and sections that cite no evidence are flagged. Model-assessed scores are labelled as such.
One-size-fits-all prompts
Purpose-built packs encode domain expertise, regulatory context, and therapeutic area nuance that general models lack.
No audit trail
Each report records the model, the sources retrieved, and the run parameters. Reviewer sign-off and exportable audit trails are in development.
Therapeutic Areas
Evidence Packs are organized by therapeutic domain, with further packs for regulatory strategy, biomarkers, CMC, and competitive intelligence.
Oncology
Trial design, dose optimization, biomarker-driven patient selection, and regulatory strategy for solid tumors and hematologic malignancies.
8 packsRegulatory Strategy
IND/NDA/BLA filing strategy, breakthrough therapy designation support, and global regulatory pathway analysis.
6 packsBiomarker & Translational
Biomarker discovery, analytical validation, clinical utility assessment, and companion diagnostic development evidence.
5 packsCMC & Quality
Excipient justification, manufacturing process validation, stability study design, and quality-by-design intelligence.
4 packsCompetitive Intelligence
Pipeline monitoring, clinical trial benchmarking, patent landscape analysis, and market positioning evidence.
3 packsFeatured Evidence Packs
Packs you can explore today. Reports are drafts for expert review, not final regulatory advice.
Oncology Trial Design Pack
Evidence-grounded protocol design for solid tumor and hematologic malignancy trials.
Synthesizes historical trial data, regulatory precedent, and biomarker stratification evidence to generate protocol design recommendations aligned with current FDA guidance.
Dose Optimization Pack
Model-informed dosing strategies backed by PK/PD evidence.
Aggregates exposure-response relationships, toxicity profiles, and dose-finding study outcomes to recommend optimal dose selection and schedule justification.
FDA IND Strategy Pack
Comprehensive IND-enabling intelligence from pre-clinical to first-in-human.
Analyzes FDA guidance documents, recent IND approvals, clinical hold patterns, and CMC expectations to deliver a risk-adjusted IND filing strategy.
Biomarker Validation Pack
Analytical and clinical validation evidence for companion diagnostics.
Evaluates biomarker sensitivity, specificity, and predictive value across published datasets and regulatory submissions to support CDx development.
Excipient Justification Pack
Regulatory-ready excipient safety and precedent analysis.
Cross-references IIG database entries, toxicological data, and approved product formulations to build evidence-based excipient justification dossiers.
Competitive Landscape Pack
Real-time pipeline intelligence with clinical and commercial context.
Monitors clinical trial registries, SEC filings, conference abstracts, and patent databases to deliver actionable competitive intelligence reports.
Find the Right Pack in Seconds
The Scientific Selector uses a guided, decision-tree approach to match your therapeutic area, development stage, and analytical need to the most relevant Evidence Packs -- no browsing required.
What is your therapeutic area?
What stage is your program?
What decision do you need to support?
Recommended: Oncology Trial Design Pack (ONC-001) -- 97% relevance
Evidence Integrity by Design
Every report is built around three principles: traceable citations, transparent evidence support, and a provenance record. Reports are drafts for qualified expert review.
Verifiable Citations
Reports cite numbered source passages retrieved from ClinicalTrials.gov, PubMed, and FDA records. Each citation shows its source title and identifier so reviewers can check statements against the original.
Transparent Evidence Support
Each section shows how strongly the sources it cites match the question, and sections that cite no evidence are flagged. Model-assessed scores are labelled as such and are not independently validated.
Complete Provenance
Each report records which sources were retrieved, the model used, and the run parameters. Exportable audit trails and reviewer sign-off are in development.
Validation Framework
Our validation framework defines the stages a pack must pass before it is marked Published. It is informed by ICH guidelines, FDA guidance on AI in drug development, and principles of systematic evidence review. Each pack shows its current maturity level.
Source Qualification
Evidence sources are tiered by reliability: peer-reviewed publications, regulatory databases, and preprints each receive appropriate weight.
Cross-Validation
Key assertions are validated against multiple independent sources. Conflicting evidence is surfaced, not suppressed.
Expert Review
Subject-matter experts review pack outputs against known ground truth before publication. Edge cases and limitations are documented.
Continuous Monitoring
Published packs are re-validated when source data is updated. Version history and changelogs maintain full traceability.
Pack Lifecycle
Draft
Initial configuration of evidence sources, agent workflows, and output schemas.
Validated
Passed source qualification, cross-validation, and expert review gates.
Published
Approved for production use with documented confidence thresholds and limitations.
Monitored
Re-validation when source data or guidance changes.
Enterprise Ready
Designed for regulated industries. We are building toward the security, access-control, and audit capabilities pharmaceutical and biotech organizations expect. Items marked in development are not yet available.
Data Security
- Encrypted in transit (TLS) on managed cloud infrastructure
- Evidence corpus is public data; do not submit patient-level or personal data
- Your content is not used to train models
- Private tenant workspaces: in development
Regulatory Alignment
- Built around GxP and 21 CFR Part 11 principles: traceability, audit trail, access control
- Compliance certifications: not yet held
- Formal system validation documentation: in development
Team & Access Control
- User accounts and roles: in development
- SSO / SAML: planned
- Activity logging: in development
Audit & Traceability
- Run records and source references saved with saved reports
- Version-controlled pack definitions
- Exportable provenance records: in development
- Reviewer sign-off and change control: in development
Usage Analytics
- Run history for saved reports
- Team dashboards and BI export: planned
Integration & API
- JSON export of reports: available
- Word and PDF export: in development
- Evidence Pack API for programmatic access: in development