Platform teams
Interoperable JSON‑LD contexts; RBAC, audit logs, and one‑click exports.
Regulatory-grade FAIR metadata infrastructure for preclinical research
Metadatapp solves one of the biggest bottlenecks in preclinical R&D: scattered, inconsistent, and poorly reusable metadata. It provides a unified, API-first environment that connects preclinical actors with regulators through regulator-ready metadata and exports (SEND, IND, IMPD) aligned with FDA, EMA, and ICH S11 expectations.
What Metadatapp does
Metadatapp is an infrastructure platform built as layers, not a replacement for existing tools.
FAIR metadata layer (semantic, ontology-driven)
A shared metadata layer that standardizes preclinical evidence with controlled vocabularies, schemas, and provenance so data stays reusable and regulator-ready.
Interoperability layer (ELN, LIMS, CRO systems)
Connects the systems teams already use and harmonizes metadata across labs, CROs, and sponsors without changing day-to-day workflows.
Regulatory outputs (SEND, IND, IMPD)
Generates regulator-ready packages with traceability, auditability, and consistency across studies.
Who benefits?
Labs
Templates for common protocols, collaboration without spreadsheets, and 3Rs traceability.
CROs
Regulator-ready outputs (SEND, IND, IMPD), standardized intake/outputs, and defensible SLAs.
Pharma & biotech
Submission-grade metadata and traceability that de-risks regulator review for IND and IMPD packages.
Governance & auditability
Evidence governance
- Data governance with role-based access and audit trails
- Validation rules and provenance capture across studies
- Retention and integrity controls for regulator readiness
Compliance outputs
- SEND-ready metadata and IND/IMPD traceability
- Audit-ready reporting aligned with FDA, EMA, and ICH S11
Seamless Integrations
LIMS/AMS Systems
Connect with laboratory and colony management systems for automated data flow.
Electronic Lab Notebooks
Integrate with ELNs to capture experimental procedures and observations.
Animal Management
Connect with systems for comprehensive animal tracking.
ORCID / ROR
Use your unique identifiers.
Regulatory Interfaces
Research data management and specific animal reporting.
Customize your Metadatapp!
Tailored to your ecosystem and data formats.
Standards & Compliance
FAIR Principles
- Findable: rich metadata/search
- Accessible: open protocols/auth
- Interoperable: JSON-LD and standard schemas
- Reusable: provenance and versioning. Learn more in FAIR-by-Design.
3Rs Alignment
- Reduction: optimize design
- Refinement: improve welfare
- Replacement: support alternatives
- Ethical oversight and compliance
FAIRRR
Any instance managed through Metadatapp will be FAIR and thus 3Rs aligned; data choices translate to welfare decisions.
Regulatory outputs
Architecture at a glance
Validate regulator-ready evidence alignment
Confirm SEND, IND, IMPD, and audit readiness for your portfolio.