Two rigorous pathways from data intake to regulatory sign-off.
Explore how Zen Health transforms pharmacovigilance case review into defensible records and clinical trial concepts into ICH M11 protocols.
Zen Case AI: Pharmacovigilance Medical Review
From omnichannel case intake to 21 CFR Part 11 dual-signed, defensible audit trails.
Omnichannel Intake & Automated De-Identification
Safety cases ingest via E2B(R2/R3) XML, enterprise safety database connectors, or unstructured PDF/DOCX files. Automated de-identification pipelines scrub patient identifiers (PHI/PII) prior to medical review while preserving complete data provenance.
Medical Review Intelligence Pipeline
Cases are evaluated across specialized clinical domains including adverse event detection, MedDRA coding hierarchy, product label evidence correlation, duplicate candidate screening, case quality scoring (0–100), and chronological timeline reconstruction.
Physician Reviewer Workspace Adjudication
Credentialed medical reviewers inspect findings side-by-side with original source documents. Reviewers accept, modify, or request follow-up with mandatory clinical rationale. AI suggestions are strictly non-authoritative.
21 CFR Part 11 Dual Electronic Signatures
Critical cases require dual sign-off (Primary Reviewer + Quality/Governance Signer) with secure OTP re-authentication. Cryptographic signatures bind reviewer identity, clinical rationale, and timestamp to immutable append-only audit ledgers.
E2B(R3) XML Export & Aggregate Safety Reporting
Approved cases automatically generate validated ICH E2B(R3) XML files for health authority filing, a tamper-evident Case Evidence Pack.
Zen Protocol AI: ICH M11 Authoring & Feasibility
From study synopsis to Monte Carlo simulation and eCTD/USDM submission packages.
Study Intake & Legacy Protocol Conversion
Ingest clinical trial synopses, unstructured concepts, or upload existing legacy protocol documents (PDF/DOCX). The Protocol Converter maps raw documents into normalized ICH M11 structures.
ICH M11 Protocol Studio Authoring
Guided 5-step authoring environment structuring content across 133 standardized ICH M11 protocol sections. An intelligent dependency impact analysis engine tracks cross-section consistency when amendments occur.
Computable Eligibility Criteria & Rule Evaluation
Free-text inclusion/exclusion criteria are compiled into computable, deterministic rule sets evaluated across patient cohorts with complete statistical consistency.
Monte Carlo Feasibility & Timeline Simulation
Runs statistical accrual modeling factoring in site activation timelines and patient dropout rates. Computes Probability of Success (PoS) scores and P10/P50/P90 enrollment completion milestones.
Regulatory Submission & eCTD Compliance Export
Generates submission-ready ICH M11 structured documents, USDM data models, and eCTD compliance packages in DOCX, PDF, XML, and ZIP formats.
Experience the workflows on your own cases or protocols.
Run a 1-month pilot on a sample of your historical safety cases (Zen Case AI) or test protocol authoring with feasibility forecasting (Zen Protocol AI).