Evidence and governance
A conclusion you cannot trace is not a conclusion
Decidian separates intelligence, governance, and execution. Intelligence is automated, governance is controlled, and execution is orchestrated through qualified people and organizations rather than falsely replaced.
Traceability
What a reviewer can follow
A reviewer can navigate from any material claim through every step that produced it.
- Source document and the exact span an extraction came from
- Extraction and normalization version
- Model and policy version in effect at the time
- Decision object, alternatives considered, and confidence
- Named approver, conditions, dissent, and override rationale
- Later observed outcome used for calibration
Separation of concerns
Intelligence, governance, execution
Intelligence
Retrieval, classification, analysis, simulation, matching, and monitoring.
Governance
Provenance, permissions, policy, human approvals, electronic signatures, decision history, and deterministic replay.
Execution
External experts, laboratories, CROs, engineering firms, manufacturers, regulatory representatives, and authorized intermediaries.
AI governance
AI governance
Governance follows the NIST AI Risk Management Framework functions: govern, map, measure, and manage. The platform maintains system cards, intended and prohibited use, evaluation evidence, a model inventory, incident process, change control, human oversight, bias testing, red-team results, and rollback procedures.
Perimeter
Regulatory and securities boundaries
Decision support, not a regulated determination
Decidian produces analysis and recommendations. Classification, submission strategy, clinical conclusions, and quality release remain the responsibility of qualified professionals with the authority to make them.
No agency relationship
Decidian has no privileged access to, relationship with, or influence over any regulator, and cannot predict or guarantee an agency outcome.
Securities perimeter
Investor features are research, permissioned discovery, diligence, and nonbinding interest. Decidian does not execute transactions or collect success-based compensation in the initial product, and nothing presented constitutes investment advice or an offer.
Records and quality context
Where records fall under FDA predicate rules, Part 11 applicability is assessed. Quality workflows are designed against the QMSR framework, which incorporates ISO 13485:2016 by reference.
Data ownership
Your data stays yours
- Founders retain raw data and project intellectual property.
- Decidian receives a limited processing license for the stated purpose only.
- Cross-client training or benchmarking requires explicit opt-in, contractual authority, de-identification, minimum cohort rules, and a re-identification risk assessment.
Claim controls
Statements we do not make
- Guaranteed FDA clearance, approval, or agency access of any kind.
- Guaranteed investment, valuation, commercialization, or clinical success.
- Named customers, partners, experts, certifications, or regulatory relationships that do not exist.
- Testimonials, revenue, market share, or investment outcomes.
- Replacement of clinicians, regulatory professionals, engineers, patent counsel, quality professionals, investment committees, or government agencies.
- Ownership of customer product data or intellectual property.
- Proposed KPIs, pilot targets, savings, accuracy, or speed improvements presented as achieved results.
Claim classification
How every statement on this site is labelled
Each page carries the evidence class of its central claim, so a reader can tell a source-supported statement from an intended capability or an untested assumption.
| Class | Meaning |
|---|---|
| Source-supported | Supported by the Decidian implementation blueprint or a cited authoritative source. |
| Product definition | An intended Decidian capability described as product design, not as a delivered result. |
| Planning assumption | A hypothesis about pricing, timing, or performance that requires validation before it is stated as fact. |
Unresolved claims register
These items cannot currently be presented as verified fact, and are published here rather than quietly omitted.
| Topic | Status | Why it is not stated as fact |
|---|---|---|
| Performance improvement | Unvalidated | Cycle-time, expert-effort, and forecast-accuracy improvements have no measured baseline. They are stated as pilot hypotheses only. |
| Pricing and unit economics | Hypothesis | Membership, module, and pilot pricing are planning ranges in the blueprint and are not published as offers. |
| Expert network scale | In formation | No expert, laboratory, CRO, manufacturer, or investor is named publicly until contracted and consented. |
| Certifications | Target, not held | SOC 2 Type II and ISO 27001 are stated as control objectives the platform is built toward, not as certifications currently held. |
| Investor activity | Boundaried | The MVP supports research, permissioned discovery, diligence, and nonbinding interest. No transaction execution or success-based compensation. |
Review the governance model with our team
We share the control objectives, the review workflow, and the conditions that force abstention.