Solutions
Our unified ecosystem
Six solutions, one spine. Every product shares forced tenant isolation, append-only tamper-evident audit chains, fail-closed authentication, and governed Claude assists — so compliance is inherited, not re-invented.
Unified Clinical Trial Bridge
Shipped · v0.1 · source-availableEU AI Act: Limited risk — Art. 50 transparencyBridges trial datapoints for pharmaceutical and research organizations, replacing fragmented systems. Automates planning, execution, and analysis for superior governance — with regulatory features aligned to ICH GCP, FDA/EMA expectations, and risk-based monitoring.
Live today — built and verified
Full product scope
EU AI Act position
Filing suggestions are labelled AI-generated, validated against the TMF catalog, filed only by a human, and logged with the model id.
Industry context
The problem, and our approach
Industry challenges
Globally, R&D suffers fragmentation: 20–30 high-cost instruments per organization, operational inefficiencies, disconnected protocols, and missing orchestration. The result is up to 70% resource wastage, prolonged timelines, and amplified disparities — obstructing affordable care.
Our unified approach
Built on and by Anthropic Claude — every AI feature is suggestion-only, validated against real catalogs, and logged to a tamper-evident audit trail. Deployment-agnostic by design: portable containers, PostgreSQL anywhere, any OIDC identity provider, any storage. Easier interfaces, cheaper models, faster outcomes — own it, or pay for it.
Global regulatory compliance
Embedded for enterprise assurance
Compliance is integral to the ecosystem — a strategic enabler of safety, integrity, and scalability, not an obligation bolted on afterwards.
Clinical & Data Integrity
ICH GCP for ethical trial conduct, risk-based monitoring, and ALCOA+ data quality — with 21 CFR Part 11 e-signatures and append-only, tamper-evident audit trails implemented in the data layer itself.
Privacy & Security
HIPAA (US) safeguards for PHI, GDPR (EU) data minimization, and regional analogs such as Mexico’s COFEPRIS and Brazil’s ANVISA — via forced row-level tenant isolation, encryption, and access logging.
AI Governance
EU AI Act conformity by tier: transparency (Art. 50) and human oversight (Art. 14) envelopes on every assist, inference logging (Art. 12/19) to the audit chain, an Annex III high-risk declaration where it applies, and FDA GMLP-aligned human-in-the-loop design.
Interoperability & Resilience
Standards-based OIDC identity, HL7/FHIR-oriented data design, portable containers, and a coordinated 90-day vulnerability-disclosure program.