Altio Decision Intelligence

The questions that matter most in R&D span safety, clinical, regulatory, and commercial data that live in separate systems, and separate heads. The constraint has never been expertise; it is synthesis time. Every one of these is answerable today by an expert with enough time:

• Signal assessment: 7+ sources to watch per product, thousands of drug-event combinations per screening run, reconciled by hand across 3+ siloed systems
• Clinical study reports: 4–6 months from database lock to final CSR, cross-checking hundreds of TLFs against text by hand, every QC round
• Periodic safety reports: a fixed 70–90 day regulatory clock, 8–12 functions rebuilding the same safety knowledge every cycle
• Health authority queries: evidence and prior positions re-assembled from scratch under time pressure

Altio makes the synthesis instant by keeping a longitudinal record of every product, study, or process, so expert judgment goes to the decision, not the search.

General-purpose LLMs are genuinely useful, and your teams are right to keep using them for low-stakes drafting and literature exploration. The line is: the moment an output touches a regulated pharmacovigilance or clinical decision, an inspector does not ask whether the answer was good; they ask whether it was validated, controlled, and traceable.

Altio complements, not replaces, the tools your teams already use. It is the governed, auditable path for the boundary where a regulated decision is on the line.

One platform, one governed record, four workflows live today: signal assessment, health-authority RFI response, safety committee pack, and the clinical study report (ICH E3), each drafted from what the last one established:

The step other drafting tools do not have: everywhere else, the work ends at export and the reasoning is gone. With Altio, each downstream deliverable (CTD, label proposals, briefing books, and in time the PBRER) becomes a view of the record, not a new project.

Judgment stays human, by construction. Altio assembles evidence and drafts; causality, interpretation, and every final decision stay with your scientists. Scientists are one of the actors in the system: roles are configurable, so the reviewers and signers can be the domain-specific roles your organization uses (for example, safety physicians, medical writers, or regulatory leads). The model itself is boxed in:

1. The model may draft and cite only from the approved sources for that deliverable.
2. The model may not compute a number, reach outside those sources, or sign anything.
3. It proves its quotes: every citation must resolve to a source you supplied, or the draft is refused, and any quotation not found verbatim in its source is dropped rather than shown.
4. It refuses rather than guesses: a missing source or data point is stated as a gap in the deliverable, with its reason recorded.

A physician or SME reviews, signs, and the record locks.

Altio COG™ (Compliance Obligation Graph, patent pending) encodes what regulatory frameworks require, so every deliverable is checked against its obligations. It works alongside the longitudinal record, which builds institutional memory, and an evidence graph that traces every statement to its source. The same mechanism runs signal assessment and the CSR: the domain changes, the governance does not.

Detailed technical and validation answers are available under NDA. Send us a message.

Four workflows live today, across safety and clinical: signal assessment, health-authority RFI response, safety committee pack, and the clinical study report (ICH E3). The first three share one signal record (a signal assessment flows into the HA RFI or committee pack it triggers), and all four are e-signed and on the record.

Natural progression, with a design partner: PBRER/PSUR continuous benefit-risk intelligence is not built in Altio today; it is the natural next step from the signal record, built with a design partner. CTD module authoring follows the same pattern, drafted from the same record.

Roadmap: regulatory is next on the same core, followed by quality & manufacturing and medical affairs & evidence. The obligations swap; the mechanism does not. Regulatory intelligence and label-change monitoring is a suggested use case, built with a design partner.

Altio deploys in a dedicated Altio-managed VPC or on premises, alongside your systems of record; it does not replace them. Intake draws on public data such as FAERS alongside the documents you bring from your safety database, literature, and document management system, and signed deliverables flow downstream to Veeva Vault by API. Sponsor data never trains our models.

Two motions cover the flow of work: Deliver: regulated documents drafted with evidence in place, reviewed and signed by a named person; and Answer: any question across the modules you have deployed, ad hoc, with sources quoted verbatim; cross-domain reach grows as each new module is added.

First engagements fit inside your existing process, and rollout expands as teams adopt it.

It never fills a gap with a guess. If an input needed for a statistic sits outside the approved sources for that deliverable, or a source file is missing data the method needs, Altio states what is missing in the deliverable, so the reviewer knows what to obtain, and records the reason, instead of producing a plausible-looking gap-filler. A draft carrying a citation that does not resolve to a source you supplied is refused, and any quotation not found verbatim in its source is dropped rather than shown.

It depends on the workflow. For signal management, a Value Confirmation on historical signals is the fastest path to confidence. For clinical study reporting, teams reach steady state over several months of supervised use, with full human review throughout. Altio does not retrain itself on your edits; improvements are captured as team configuration under change control.

Detailed technical and validation answers are available under NDA. Send us a message.

Yes. The governed chain produces artifacts, not claims: every obligation is traced to a requirement, a test, and a recorded verdict. Tests are pass or fail only, qualification phases run in order, and any amendment triggers requalification.

The Provider Evidence Package (25 governance templates across 8 modules, mapped against ISO 42001, GxP, 21 CFR Part 11, GDPR, and CIOMS AI in Pharmacovigilance) is available, and the full qualification record is shared with your quality unit under NDA.

Detailed technical and validation answers are available under NDA. Send us a message.

Altio's risk profile is minimal/limited risk; it is not classified as high-risk under the EU AI Act. Its current intended uses (pharmacovigilance signal management and clinical study reporting) support a qualified person's decision rather than making one, with a human reviewer making and signing every decision. Human-in-the-loop is a structural design control, not a mitigation bolted on afterward.

Altio meets the Act's transparency (Article 50) and AI literacy (Article 4) duties: every signed deliverable is marked as AI-assisted in a form software can detect.

Altio is classified GAMP Category 5 (custom software used in a regulated process), specified against its stated intended use as each feature is built, with the documented chain from user requirements → software requirements → design specification → IQ → OQ → PQ, and electronic signatures and audit trails under 21 CFR Part 11 and EU Annex 11. Each test names the requirement it exercises, and execution against a deployed system is the gate before production handover; we do not describe the product as validated until that execution has run. Customer-facing configuration (SOPs, templates, obligation nodes) is treated as Category 4 under your own change control, so your qualification effort concentrates on what you change, not on re-testing the core.

Your quality unit adds the site-specific layer: an intended-use statement and risk assessment, IQ in your deployment (version, configuration, integrations), OQ against your configured SOPs and obligations, and PQ as a retrospective comparison on completed work, executed and signed by your Quality unit, reusing our specification and qualification evidence rather than starting over.

Continuously. A regression set re-runs before every release, and ingestion, outputs, and reviewer acceptance are all monitored. Every run is recorded against the exact model, prompt, and document versions it used, so any issue traces to the deliverables it affected and is raised as a deviation under change control.

Change control: any model, prompt, source, or obligation change is a release. Nothing is silently rewritten.

Detailed technical and validation answers are available under NDA. Send us a message.

They answer different questions, and we never substitute one for the other. TRL (NASA's nine-step Technology Readiness Level scale) measures maturity: how far the application has been proven toward routine operational use. GAMP 5 and validation measure fitness for a stated intended use in a specific environment.

For signal management, Altio is TRL 4 today: tested in a controlled environment on sample and de-identified data. For clinical study reporting, a customer assessment on real study data is complete. TRL 6–7 follows Value Confirmation and deployment in your environment; TRL 8–9 is roadmap. Altio COG's horizontal frameworks (EU AI Act, GDPR, ISO 42001, 21 CFR Part 11) sit alongside domain frameworks (EU GVP Module IX, CIOMS AI in PV, ICH E3) as obligation data the graph is qualified against.

A gate advances on evidence, never on intent.

Altio runs as a staged, agentic workflow with a check at every stage, so a failure is contained and auditable. It is model- and provider-agnostic, and a model switch is regression-tested before release.

It deploys in a dedicated Altio-managed VPC or on premises, ingests public data such as FAERS alongside the documents you bring, connects downstream to Veeva Vault by API, and sponsor data never trains a model. With the same inputs, retrieval, citations, and every computed number are reproducible run to run.

Detailed technical and validation answers are available under NDA. Send us a message.

No. Statistics run as deterministic, versioned code after a person approves the analysis plan, and every figure traces to the rows behind it. Trial data and case-level data are each handled with methods suited to them, including standard disproportionality measures.

Where data is too thin to interpret, or a needed field is missing, Altio says so rather than showing a number. Proven on real data: 3,379 cases screened to 1,205 ranked event terms, checked against 20M+ FDA reports.

Yes, for both, and the options combine:

• Release approval: no model or prompt release promotes to your deployment until your designated owner approves it, with regression evidence attached
• Version pinning: pin a prompt version per workflow and opt into updates on your own cadence; the pinned version still receives security fixes
• Customer-owned prompt text: for specific sections (e.g. CSR templates), you own the prompt text under your own change control; our harness treats it as configuration

A prompt change is still a release: it runs against the sealed regression set and frozen baseline, and stales the records it affects like any other change.

Every document is recorded on the longitudinal record with its ingestion date and version. When a newer version arrives, Altio flags the claims that depended on the older one for review, rather than letting them persist silently.

Public sources ingested, such as FAERS, carry their date stamp automatically. For internal documents you bring, the SME confirms the controlled version at ingestion.

No. Your content never enters any training, evaluation, or prompt-improvement loop. Product improvement runs on our own material; using your content would require your explicit, separately negotiated agreement.

In the region you choose. EU and US regions are both available; the region is fixed before any data enters and recorded in your agreement, and model inference runs in the same region. On premises, residency is entirely yours.

No. Each customer gets a dedicated Altio-managed VPC with its own network, compute, database, storage, and encryption keys, so there is no shared datastore or shared application tier through which one customer's content could reach another. Altio can also run on premises, inside your own boundary.

No. Source material is de-identified at intake, before anything is stored, and the original file is not retained. De-identification is one-way: there is no re-identification key anywhere in the system, so identifiers cannot be restored by us or by anyone else.

If a source cannot be fully de-identified, it is refused outright and the refusal is recorded. Value Confirmation deployments go further and refuse any source containing patient identifiers.

No Altio person holds an account in your system, and there is no support back door: sign-in runs through your own identity provider. In the Altio-managed mode we operate the infrastructure your VPC runs on, so access exists at that level; it is not used to read your content, and its terms are set in your agreement. On premises, Altio has no access path at all.

• Encryption: at rest, with keys dedicated to your deployment, and in transit over TLS
• Access: single sign-on through your identity provider, with no anonymous access or self-registration; idle sessions expire
• Signatures: every signature requires fresh re-authentication at the moment of signing, as 21 CFR Part 11 requires
• No outbound path: the components holding your data cannot send it to the internet, and model inference never crosses the public internet. You can always download sources, export deliverables, or take a signed export of the whole record
• Audit trail: consequential actions are recorded in an append-only trail that the application itself cannot alter

In the Altio-managed mode, Amazon Web Services is the only sub-processor, providing compute, storage, model inference, and key management. It is disclosed for your authorization in the data processing agreement, and no further sub-processor is added without notice to you. Your identity provider is yours, not a sub-processor of ours.

Yes. The model and its version are fixed per deployment, recorded as versioned configuration, and disclosed to you. Changing it is a controlled change, never a silent update.

Inputs are screened for prompt injection before drafting, and again for any answers supplied mid-run, so instructions hidden in a document never reach drafting unscreened. Output is filtered for personal data on a default-deny basis: it is withheld unless affirmatively cleared, and withheld if the filter itself fails. Every citation must resolve to a source you supplied, or the draft is refused.

Yes. Every signed deliverable carries a marker identifying AI-assisted content in a form software can detect, a cryptographic signature, and a verification tool you can run independently of us.

Retention is set per deployment and recorded in your agreement. Production deployments are configured to the pharmacovigilance retention period (the life of the marketing authorization plus ten years), and the system refuses a shorter configuration. There is no user-facing delete button for safety records, by design; deletion happens on the retention schedule under controlled conditions.

When a Value Confirmation or engagement ends, you receive a signed export of the full record, its completeness is verified, and only then is the VPC destroyed and its keys deleted.

You are the controller: you decide the purposes, bring the source material, and own the resulting safety records. Altio is the processor, operating the system on your instruction. Under the EU AI Act, the same split makes Altio the provider and you the deployer. We support your obligations with:

• A prepared, processor-side data protection impact assessment for you to adopt (GDPR Article 35)
• A data processing agreement covering instructions, confidentiality, security, sub-processors, assistance, deletion, and audit (Article 28)
• The processor-side record of processing for your deployment (Article 30)
• Help with data subject requests (Articles 15 to 22), including evidencing the pharmacovigilance retention exemptions
• Breach notification without undue delay, with what you need for your own 72-hour assessment (Articles 33 and 34)

Not today, and we intend to be. We would rather tell you where we are than carry it as a roadmap line. What exists now is what regulated pharmacovigilance buyers usually weigh more: a version-controlled specification and qualification chain (user requirements, software requirements, and design specification, each proven by its qualification), built alongside each feature, where execution against a deployed system is the gate before production handover. If a certificate is a precondition for you, tell us early.

Continuously, and with the same discipline as the product: AI assists with discovery, but deterministic checks decide what counts as a finding, and every finding is challenged against the actual code before it is acted on. Testing runs only against explicitly permitted targets, inside isolated environments. Every fix is regression-tested and approved by a person before it ships.

Our Data Processing Overview, written for privacy, security, and vendor-assessment teams, is available on request. Send us a message.

2–4 weeks, one workflow you choose, jointly staffed and jointly funded. You commit a small named team and a fixed fee, credited toward deployment on a go decision; Altio commits senior domain, product, and engineering time. Success criteria are agreed in writing before it starts. It runs in a VPC dedicated to your organization, so your data stays isolated and secure, on work you have already closed (historical signals, or a completed study for a CSR), so no live decision depends on it. It ends with a go/no-go decision based on a blinded comparison against your own assessments, measured against the criteria you set.

A Value Confirmation deployment refuses any source containing patient identifiers, so you can assess Altio without patient data entering it. It runs for a fixed term and ends with a signed export of the full record; only after its completeness is verified is the VPC destroyed and its keys deleted.

Before Value Confirmation: a 60-minute demo at no cost, on one workflow of your choice, walked through on a deliverable you produce today. Book a time.

After a go decision, deployment moves into a dedicated Altio-managed VPC or on premises, where your quality unit completes site-specific qualification, and scales over several months with a small group of senior writers.

In one customer assessment, Altio produced a first fully cited CSR draft, including custom sections beyond the ICH E3 template, in about 20 minutes.

Detailed technical and validation answers are available under NDA. Send us a message.

Hours-saved framing undersells what is changing. Speed is real (a first fully cited CSR draft in about 20 minutes), but it is the entry point, not the value metric. The metric we hold ourselves to is different by deliverable, but the shape is the same:

• Signal management: not hours saved, but a signal log that defends itself at inspection, every disposition named, reasoned, and traceable
• CSR: not weeks saved per report, but months off the critical path to submission, with study knowledge flowing straight into the CTD and PBRER
• PBRER (a natural progression, built with a design partner): not days saved per cycle, but a continuously current benefit-risk position that makes every periodic report a traceable view of the same record

The signal-to-obligation multiplier: evidence assembled once at assessment is otherwise re-extracted by hand for the PBRER, the signal register, RMP, label proposals, and HA RFIs. With the record, each becomes a view, not a project.

The technology-readiness path is evidence-gated, not calendar-gated: TRL 4 today for signal management (tested in a controlled environment; the CSR workflow has also completed a customer assessment on real study data) → TRL 6–7 follows Value Confirmation and deployment in your environment → TRL 8–9 on the roadmap as confirmed-value engagements convert to live deployments.

Domain expansion follows the same rule: new use cases inherit the record, the obligations, and the controls, built once and reused everywhere, rather than starting again: safety and clinical are live; regulatory is next on the same core; quality & manufacturing and medical affairs & evidence are roadmap.

We deliberately do not publish a rate card here: engagement scope, deployment model (VPC vs. on-premise), and domain (signal management vs. CSR vs. a future domain) all move cost enough that a generic number would mislead more than it informs. What is consistent across engagements:

• Engagement runs in two stages: confirm the value, then realize it.
• Value Confirmation: 2–4 weeks, fixed fee, on a workflow you choose, jointly staffed, with success criteria agreed up front. It runs in a VPC dedicated to your organization so your data stays secure, and is scoped in a working session with your Quality, IT, and Safety leads. On a go decision, the fee is credited toward deployment.
• Value Realization: deployment in a dedicated Altio-managed VPC or on premises, priced against the value confirmed and your data volume and workflow footprint, not sold as a bundled black box. A CSR deployment takes 3–6 months to steady state.
• You keep the evidence pack and Value Confirmation record either way; expand or stop, the decision and its evidence are yours.

A scoping call agrees what the Value Confirmation should prove and gives you a real cost range for both stages. Book one through the contact details below.

Not in the usual sense. The first step is a 60-minute demo at no cost: one workflow of your choice, end to end, walked through on a deliverable you produce today. Book a time. We do not run free trials, because a trial asks whether there might be value. Altio is built to solve a specific, costly problem, and Value Confirmation confirms that value on your data, your templates, and your governance context. It is 2–4 weeks, fixed fee, and jointly staffed, because commitment on both sides keeps it on schedule and ends it in a go/no-go decision on evidence rather than a sales demo.

Keep using them; they are excellent for low-stakes drafting, literature exploration, and internal productivity. The question is not whether to use AI; it is whether the AI touching a regulated decision can withstand inspection. Ad hoc tools have no intended-use statement or risk classification on file, no versioned audit trail linking input/model/approved output, and no revalidation trigger when the model changes silently underneath.

Altio is the governed, auditable path for exactly that boundary, and it complements the general-purpose tools your teams already rely on rather than replacing them.

TRL and GxP validation answer different questions. For signal management, TRL 4 means the integrated application is tested in a controlled environment on sample and de-identified data. That is a maturity measure, not a compliance gap. For clinical study reporting, a customer assessment on real study data is already complete. The specification and qualification chain is separate evidence, built alongside each feature: GAMP 5 Category 5 classification, traced requirements, automated pass/fail testing, and phase-gated IQ/OQ/PQ under 21 CFR Part 11 and EU Annex 11, where execution against a deployed system is the gate before production handover. The full record is available under NDA.

What TRL 4 does mean honestly: it has not yet run against your SOPs, data, systems, and reviewers. Value Confirmation is the first step toward closing that gap, on your data and workflow; completing OQ/PQ in your environment at deployment is what advances the application to TRL 6–7, on your evidence.

Every model, prompt, source, or obligation change is a release: regression-tested against a frozen baseline before promotion, and it stales the records it affects. You control the cadence: release approval before anything promotes to your deployment, version pinning per workflow, or customer-owned prompt text for specific sections under your own change control.

Regulators audit: "Show me the change log": every change is logged with rationale and validation results; "Did you re-validate?": re-validation runs against the sealed regression set and is on the record.

That is the architecture, not a wish. The longitudinal record, Altio COG™ obligation graph, and evidence graph are domain-agnostic by design: signal assessment and the CSR already run on the same mechanism with different guidelines swapped in. Regulatory (CTD, briefing books) is next on the same core; quality & manufacturing and medical affairs & evidence follow.

One enterprise can run many longitudinal records (one per product, study, site, or process), all governed by the same obligation-and-evidence architecture, built once and reused everywhere.

The Provider Evidence Package, commitment register, and SOPs are governance artifacts you hold and sign, not claims made in a meeting. The Value Confirmation record and evidence pack are yours to keep whether you expand or stop. Altio is also model- and provider-agnostic: a switch to another model or provider is handled as a configuration change on our side, not a re-architecture on yours.