AI for AI® · DSAIL® Verification Engine
Use AI agents for life science decisions you can prove
Put AI behind submissions, safety, quality, and medical communications.
Every module summary, protocol amendment, or safety narrative is checked against encoded policy before it reaches a reviewer, an inspector, or an agency. Not a smarter prompt. Formal proof.
Built for the standards governing life sciences AI
The standards your inspector will ask about. Jaxon encodes them as enforceable logic — select one to see where it is verified.
By the numbers
Four facts that frame every conversation about AI in life sciences.
The pressure
The answer
The FDA and EMA published joint guiding principles for good AI practice in drug development.
Source: Guiding principles of good AI practice in drug development.
GPT, Claude, Gemini, or your proprietary model. No retraining.
Six leading models repeated or elaborated a planted error in physician-written clinical vignettes. Mitigation prompting halved the rate. It did not remove it.
Source: Omar et al., Communications Medicine, 2025.
Author your standard once; verified on every AI output at runtime.
Highest-value deployments. Regulatory submission, eCTD consistency, pharmacovigilance, and safety narrative governance. For organizations filing with the FDA, EMA, and other regulatory agencies as safety volumes climb, deterministic verification delivers the clearest and most immediate return. The constraint was never the model. The challenge is proving that every output continues to conform to ICH guidance, your SOPs, your safety governance, and the approved label.
Why probability isn't proof
AI is already inside submissions, safety, and medical content. The question is whether you can answer for it.
Most AI controls ask a second model to grade the first. That is still a probability — prompt engineering and retrieval grounding lower the error rate without changing what it is.
A confidence score
A Jaxon verdict
Score
It slides with the model.
Deterministic code computes the verdict.
Re-run
Ask again tomorrow and the number moves.
The policy logic never lives inside a prompt.
Exam
It cannot be produced in an inspection.
Your standards, compiled by DSAIL®.
Jaxon splits the work. The LLM does what LLMs are good at: it reads the document and answers tightly scoped, rule-specific questions — does this figure match the value in the module it cites?
DSAIL® (Domain-Specific AI Language) computes the verdict.
The problem
AI you cannot verify is AI you cannot defend.
AI drafting module summaries, protocol amendments, safety narratives, and quality investigations introduces errors precisely where they are least tolerable. Jaxon sits as an API layer between your LLM workflow and the output, and it checks each assertion before the document becomes a record.
✕Without Jaxon
AI remains stuck in pilot programs.
✓With Jaxon
AI moves into production, with the proof attached.
One of three, every time — and each one names the rule that produced it.
A model that cannot say it does not know will guess. UNKNOWN is where the guess would have been.
Use cases · Life Sciences
Five document systems, one verification layer.
Clinical, regulatory, quality, and safety each answer to different guidance and file different documents. They share one problem: an AI output nobody can prove. Jaxon encodes each standard separately and applies the same deterministic check to all of them.
File sooner with an internally consistent dossier the first time.
Regulatory Affairs Leads · Medical Writers
Regulatory submission and eCTD consistency. Submissions are the throughput bottleneck of the entire pipeline, and AI is now widely used to draft and assemble the documents that populate them. The failure mode is not bad prose. It is inconsistency, and every inconsistency becomes a review question, and review questions become months.
Jaxon encodes ICH M4 structure, submission validation criteria, and your own submission standards as enforceable rules.
Immediate fit · highest near-term deployment value
What Jaxon verifies
- Narrative claims verified against the underlying study data and predefined endpoints.
- eCTD structural and validation criteria enforced before compilation.
- Cross-module consistency enforced across summaries, tables, and the sections they reference.
- Reused content from prior submissions re-verified against current data, not assumed.
- Per-document audit trace recorded — the provenance record that makes AI-assisted authoring defensible.
Amend faster without losing the thread.
Clinical Operations Leads · Biostatisticians
Clinical protocol, SAP, and amendment governance. Protocols, statistical analysis plans, and investigator brochures are a single logical system spread across many documents and many versions. Inconsistencies between protocol versions, endpoint definitions, statistical thresholds, and inclusion and exclusion criteria delay approvals and produce audit findings.
Jaxon encodes ICH GCP expectations, sponsor protocol templates, statistical parameters, and eligibility logic as enforceable constraints, then checks every AI-generated draft or amendment against the approved versions before release.
Strong fit · document integrity across global trial sites
What Jaxon verifies
- Endpoint definitions proved consistent across protocol, SAP, and investigator brochure.
- Inclusion and exclusion criteria verified as internally consistent and consistent with the approved protocol.
- Amendments checked against the approved statistical analysis plan and all prior versions.
- Sponsor template and ICH GCP documentation requirements enforced per document.
- Version-controlled trace per amendment recorded — the inspection record across every trial site.
Hold case throughput without asserting what the source report never said.
Pharmacovigilance Leads · Safety Reviewers
Pharmacovigilance and safety narrative governance. Pharmacovigilance may represent one of the highest-volume AI adoption opportunities in life sciences, and one of the highest-consequence failure environments.
The industry's current answer is retrieval grounding, confidence scoring, and mandatory human verification at the end of every case, which caps throughput at exactly the point where volume is growing.
Immediate fit · high volume, high regulatory scrutiny
What Jaxon verifies
- Narrative statements verified against the underlying case report — nothing is asserted that the underlying source does not support.
- Seriousness and expectedness determinations checked against documented criteria per case.
- Escalation and reporting triggers verified as having been applied.
- ICSR completeness and jurisdictional reporting obligations enforced per market.
- Inspection-ready trace per case recorded — the safety organization's defensibility layer.
Close investigations faster with documentation that holds.
Quality Assurance Leads · QA Investigators
GMP quality records, deviations, and CAPA. The risk shifts from calculation error to procedural non-conformance.
Jaxon encodes SOP boundaries, validated process parameters, escalation thresholds, and data integrity requirements as enforceable rules governing every AI-generated quality output.
Strong fit · where the regulator has already drawn the line
What Jaxon verifies
- Investigation conclusions and CAPA recommendations supported by the underlying data.
- Out-of-specification escalation criteria applied before close-out.
- SOP boundaries and validated process parameters enforced per recommendation.
- Data integrity and ALCOA+ expectations checked per record.
- Inspection-ready trace per investigation recorded — which rule ran, what was checked, what was flagged.
Turn the review queue into a verified pipeline.
Medical Affairs Leads · MLR Reviewers
Medical, legal, and regulatory review. Medical and promotional content represents one of the largest document workflows in many life-sciences organizations and one of the clearest applications for AI-for-AI® verification. Medical and commercial teams use LLMs to draft medical information responses, congress materials, field content, and promotional pieces, and the review queue is the acknowledged bottleneck.
Every piece carries the same exposure: a claim outside the approved label, an implied off-label use, an efficacy statement stronger than the evidence, missing required safety language, or inadequate fair balance.
Jaxon encodes the approved label and prescribing information, contraindications, required safety language, and your review standards as enforceable rules — turning the review bottleneck into a verified pipeline.
Strong fit · highest-volume content flow
What Jaxon verifies
- Claims proved consistent with the approved label and prescribing information.
- Required safety language and fair balance verified as present per piece.
- Potential off-label implications and unsupported efficacy language flagged as structured exceptions before distribution.
- Jurisdiction-specific promotional requirements applied per market.
- Documented review trace per piece recorded — evidence of a consistently applied review standard.
How it works
How Jaxon verifies an AI output: output in, verdict out, token logged.
Deterministic · signed verification token · auditable trace for every determination
Where the rules come from
Your standards, in your own language.
Your domain experts state the standard in their own language. An LLM-assisted workflow distills it into a clear ruleset, compiles that ruleset into formal DSAIL® logic, and derives the questions the LLM must answer at runtime.
One artifact, not model weights.
The unit you author is the rule: rule text, DSAIL® logic, and the claims it checks. Version-controlled, like code. A guidance change is a rule change, not a retraining cycle.
For the developer — how you integrate
Define policy rules
Your team — with Jaxon’s onboarding — authors rules in DSAIL®, a domain-specific language that encodes ICH guidance, submission standards, protocol logic, and SOPs as formal logic. Rules compile once and deploy as a versioned, auditable artifact.
Call the API at output
After your LLM generates the draft, POST the output, the source record, and the ruleset context to Jaxon’s REST endpoint. Any language, any framework, any model — no vendor lock.
Parse the verdict
Jaxon returns JSON, one of three verdicts. TRUE: advances, with a cryptographically signed audit token. FALSE: blocks, with a structured exception object (rule_id, violation_type, field, governing_text). UNKNOWN: returned when the source material does not support a deterministic verdict, rather than a probabilistic guess being made in its place.
Log & chain of custody
Every response carries a cryptographically signed verification token binding the output, the ruleset version, the verdict, and the timestamp — ALCOA+ attributable and contemporaneous by construction. Store it alongside the record; produce it to QA, an inspector, or a sponsor audit on request.
Benchmarked against frontier AI
The only system in the test that could prove it
Three models — GPT-5.2, o4-mini, and Gemini 3 Pro — ran two ways each: once with DSAIL® enforcing the rules, once with RAG alone; same models, same inputs. The only variable was DSAIL®.
Only DSAIL produced a human-auditable reasoning trace on every determination. Because the architecture is deterministic, any organization can run the same test against its own policy domain and verify the result. Full benchmark methodology and per-item results available on request — info@jaxon.ai
Deployment — your environment, your security model
Where must your clinical, safety, and manufacturing data stay?
Fastest to production
Most isolated
Constraint
Non-regulated workflows
Deployment 01
SaaS / Managed Cloud
Fastest time to production. Isolated, encrypted execution environments. Available via AWS Marketplace.
Constraint
Must stay in your cloud
Deployment 02
Private Cloud (VPC)
Recommended
Inside your AWS, Azure, or GCP VPC. Recommended for regulated clinical, safety, and manufacturing data.
Constraint
Must stay in your perimeter
Deployment 03
On-Premises
Deployed on your infrastructure. No data leaves your physical perimeter — no external API dependencies.
Constraint
No external connectivity
Deployment 04
Air-Gapped
Fully disconnected. Jaxon’s federal heritage backs the only commercial AI verification engine validated for mission-critical disconnected environments.
Who it’s for
Two roles, one verification layer.
Jaxon serves the quality and regulatory leader who clears AI for production, and the engineering team that has to make it work.
You own
Quality and regulatory own the rules.
Regulatory affairs, quality, pharmacovigilance, and medical leads author the policy, and version-control it. Accountability stays where it belongs: the sponsor remains responsible for the content, and Jaxon provides the documented evidence trail that supports it.
Head of Regulatory Affairs · VP Quality / QA · Head of Pharmacovigilance · Chief Medical Officer
You get
01Production, not pilots
Every module summary, amendment, narrative, and medical response is verified against encoded standards before it becomes a record.
02Exception-only workload
Jaxon clears the routine cases; judgment concentrates on the exceptions.
03Inspection readiness built in
The verification record is the documentation inspectors increasingly expect from organizations using AI.
You own
Engineering owns the integration.
DSAIL® is embedded into your existing workflows — agent pipelines, content-generation systems, decision engines, RAG stacks, or custom applications. Developers own the integration; your domain experts own the rules.
CTO · CIO · Head of R&D IT · Head of Data Science · Computational Science Lead
You get
01Weeks, not quarters
A REST call, not a platform migration. Send the AI output, the source record, and the ruleset context; any language, any framework, any model.
02Rules, not retraining
Policy rules are authored once and applied at runtime — version-controlled, auditable, updatable without retraining any model.
03Inside your security perimeter
On-premises, private cloud, or air-gapped. The deployment model follows your data, not the other way around.
Get in contact
Ready to move life sciences AI from proof-of-concept to production — and prove every output?
This is where AI governance stops being a policy document and becomes an engineering task. Jaxon’s engineering team works directly with your regulatory, quality, safety, medical, and technology functions to encode your standards and build verification into your environment.
Your standards. Your environment. A verdict you can produce.
What happens next
Bring the workflow — the one where a wrong answer is unacceptable.
We encode your first ruleset — against that workflow, on your actual documents.
You verify it in your environment — before anything is released.
Request API access
Tell us the workflow where a wrong output is unacceptable.
Or write directly: info@jaxon.ai
FAQ
Questions regulatory, quality, and safety teams ask first.
Does Jaxon make our AI use compliant?
No. Jaxon verifies AI outputs against the standards you encode and returns TRUE, FALSE, or UNKNOWN with an audit trail. You still make the compliance determination, and the sponsor remains responsible for the content. Jaxon gives you the defensible record behind it.
What is a deterministic AI verification layer?
It is a check that produces the same verdict every time for the same input and the same ruleset. Instead of asking a second model how confident it is, the LLM extracts atomic facts from the document and deterministic code — your policy compiled into formal logic — computes the verdict. The output is a proof traced to a governing citation, not a score.
Does Jaxon replace our quality system or our validation framework?
No. Jaxon is the technical substrate that makes AI-assisted work documentable inside the framework you already run. Every verification is versioned and reproducible, and the record is stored alongside the document it belongs to.
Can AI draft a case narrative or a Module 2 summary?
AI can draft it; the exposure comes next. Both documents make assertions that must hold against a source — the case report behind the narrative, the study data behind the summary — and neither the draft nor a second model can establish that. Jaxon checks each AI-generated draft against the encoded criteria before it becomes part of the record, so reviewers see either a cleared document or a named exception.
Which LLMs does Jaxon work with?
Any of them. Jaxon is a model-agnostic API layer that works with GPT, Claude, Gemini, open-source models, or your proprietary model, with minimal changes to the underlying pipeline. Rules are authored once and applied at runtime — updated when guidance or policy changes, without retraining any model.
Where can Jaxon be deployed for regulated clinical, safety, and manufacturing data?
SaaS managed cloud for non-regulated workflows, your own AWS, Azure, or GCP VPC, fully on-premises, or air-gapped. Private cloud is the recommended deployment for regulated clinical, safety, and manufacturing data.
What does the audit record actually contain?
Which rule ran, what was checked, what passed, what was held, and who resolved it. The signed token that binds each verification to its output and its ruleset version is described under How it works. What matters for an inspection is that the record exists per document and can be produced without reconstructing it after the fact.
What happens when the source document does not settle the question?
The verdict is UNKNOWN, defined narrowly: the input document did not carry what the rule needed. It is not a confidence score and not a middle state between TRUE and FALSE. Nothing is asserted in its place, and the gap is named so you can supply the missing input.