Reviewer-gated synthetic control arms, designed for submission
Trace is a Translyx pipeline capability under evaluation. It structures synthetic control arm workflows with reviewer sign-off, manual benchmark comparison, lineage, and submission-oriented packaging — for biotech, pharma, CRO, and clinical trial teams. It is not a publicly launched product.
Built for
Clinical Sponsors
Biotech and pharma teams running evidence reviews and SCA programmes
CROs
Contract research organisations managing reviewer-gated trial workflows
Academic Groups
Research teams needing governed synthetic control arm methodology
Clinical Trial Offices
Teams responsible for evidence packaging and submission preparation
Built for teams that require a defensible audit trail
Trace covers the complete synthetic control arm workflow — from workup definition to reviewed output — with mandatory reviewer sign-off at SCA generation, manual benchmark comparison throughout, and submission-oriented packaging at every stage.
Every decision point is visible. Every output carries its lineage. The workflow does not abstract away the steps that reviewers and regulators need to see.
Where Trace sits
Translyx Limited
Clinical technology company focused on diagnostics, digital pathology AI, and healthcare adoption in New Zealand.
Translyx Pipeline
Clinical AI workflow capabilities under evaluation and development — not publicly launched products.
Trace
Reviewer-gated synthetic control arm workflows with lineage, comparison workspace, and submission packaging.
Workflow
The eight-step Trace workflow
Structured to move from workup setup to reviewed evidence output without hiding the decision points that matter.
New Workup
Initiate a structured workup for a specific clinical question.
Define Question
Articulate the research question, target population, and key parameters.
Find Comparables
Identify comparable historical and real-world datasets for cohort construction.
Dataset Fit
Assess dataset suitability, coverage, and alignment with the target question.
Cohort Builder
Build treatment and control cohorts with specialist review at each stage.
Diagnostics & Review
Run diagnostics and complete reviewer sign-off before SCA generation.
SCA Analysis
Generate reviewed synthetic control arm analysis with visible lineage.
Submission Package
Export a submission-oriented package with methods, limitations, and provenance.
Comparison model
Three comparison paths inside one governed workflow
Trace is strongest when the comparison model is explicit: specialist-built manual arms remain visible, synthetic output is reviewed rather than assumed, and the final package carries all context forward.
Manual treatment arm
Specialist-entered benchmark representation of the treated population or reference treatment context. Built and reviewed before any synthetic generation.
Manual control arm
Specialist-entered benchmark control context used to assess workflow logic and comparability. Reviewed alongside the treatment arm.
Synthetic workflow output
Reviewer-gated synthetic output connected to diagnostics, lineage, and visible limitations. Not presented as a replacement for the manual arms.
Manual and synthetic comparison
Trace is not a replacement for specialist clinical judgment. Manual treatment and control arms remain central to the workflow — the synthetic output is assessed alongside them in the same governed environment, under the same reviewer accountability.
That structure produces stronger evidence packages: the benchmark remains visible, the synthetic construction is reviewed, and the final output carries both in context.
Worked example
A clinical team defines the question and target setting.
A trial specialist builds a manual treatment arm and a manual control arm.
Trace organises comparable evidence, dataset fit, and cohort construction.
Diagnostics and reviewer sign-off are completed before SCA generation.
The resulting package preserves lineage, limitations, and reviewed context.
Governance model
Governance built in, not bolted on
Reviewer gates, lineage, and visible limitations are not optional modules. They are structural features of how Trace is designed to operate.
Reviewer sign-off before SCA generation
Trace preserves a hard governance gate before any synthetic analysis can be generated. Statistics do not outrun human review.
Traceability and lineage
Each stage is structured so teams can follow exactly how evidence, cohort choices, and outputs connect through the workflow.
Visible limitations
Residual assumptions and workflow constraints stay visible rather than being hidden behind a polished output. Honest about current boundaries.
Submission-oriented packaging
Trace brings methods, reviewed decisions, provenance, and package-ready output into one coherent workflow — not an afterthought.
Honest scoping
What Trace covers — and what it does not
Included
- Reviewer sign-off gate before SCA generation
- Manual treatment arm entry and comparison
- Manual control arm entry and comparison
- Synthetic workflow output with lineage
- Visible limitations in every output
- Submission-oriented packaging
- Audit trail across all workflow stages
- Traceability of cohort construction decisions
Not included
- A publicly launched or customer-available product
- Fully automated regulatory submission
- Implied FDA, EMA, or Medsafe endorsement
- Black-box output without reviewer gate
- External patient data storage
- Guaranteed regulatory acceptance
Regulatory posture
Designed to support submission packaging — not to claim regulatory approval
Trace is designed with the intent of supporting FDA, EMA, and Medsafe submission packaging workflows. It structures evidence with the discipline those processes require. It does not claim, imply, or guarantee regulatory acceptance of any output.
Common questions
Is Trace a launched product?
No. Trace is a Translyx pipeline capability under evaluation. It is not publicly launched and is not currently available to customers. Translyx discusses the capability and evaluation pathways with interested organisations.
Does Trace claim regulatory endorsement?
No. Trace is designed to support submission-oriented packaging and reviewer-gated governance workflows. It does not claim or imply regulatory endorsement from FDA, EMA, Medsafe, or any other body. All outputs carry visible limitations.
What data residency options is Trace designed for?
Trace is designed with data residency in mind for New Zealand and regional deployments. Planned integration and export options include SAS/R-compatible outputs and audit log exports. Contact Translyx for specific infrastructure requirements.
What is the difference between the manual arms and the synthetic output?
The manual treatment arm and manual control arm are specialist-entered benchmark representations. The synthetic workflow output is a reviewer-gated statistical construction. Trace keeps all three visible in one governed environment so they can be compared, not substituted.
See the Trace capability in detail
Schedule a walkthrough of the eight-step workflow, reviewer gate model, comparison workspace, and submission-oriented output — with the Translyx team.