What we claim, and what we will not

Clinical research buyers read specifications for a living. This page states how the products handle data, AI and validation, plainly enough to check.

Where your data lives

The two products hold very different data, so they are built differently.

  • Antevra holds no patient dataIt works on protocols, supporting documents and synthetic data only. No real patient data enters the system, by design.
  • Actora runs one instance per customerYour own application and your own database. Nothing is shared with another customer.
  • Sign-in through your identity providerSingle sign-on and multi-factor authentication come from your identity provider. Signing a record asks you to authenticate again.
  • Least privilege in the databaseThe running application cannot change the schema. Clinical tables accept only appends or permitted state changes, and the database itself enforces it.
  • Access leaves evidenceRequests are logged, sessions are bound to the client that opened them, and unusual access is flagged for review.

The model reads. Rules decide. A person signs.

Antevra uses a language model to extract, propose and detect. Deterministic code decides what happens next, and a named person decides what leaves the system.

  • Every model call goes through one placeBackends can be switched, including a model you host yourself.
  • Every stage records the model that ran itA stage that did not run says so and names no model.
  • Every claim carries its quoteFindings cite a quote and its position in a specific source revision. A quote that cannot be found is flagged as possibly invented.
  • No accuracy figure we have not measuredWe show what the product verifies, its rules and its invariants, and we do not quote an extraction accuracy we have not tested.

Claims we will not make

On the left, what you may hear elsewhere. On the right, what we say instead.

  • "Part 11 certified" or "Part 11 compliant software"There is no Part 11 certification. Actora is built for Part 11 and Annex 11 controls; compliance belongs to your validated installation and SOPs.
  • "Validated software"We give you a validation pack: the requirement matrix, the test results of the exact release you install, and installation checks for your instance. You validate it for your intended use.
  • "AI-powered accuracy"The model proposes, the rules can only lower a status, and every claim cites its source. A person decides.
  • "Synthetic data you can submit"Synthetic data is for building and testing before real data exists. It is never a substitute for trial data.
  • Customer logos and savings figuresWe name no customer without written consent and quote no figure we have not measured.

Asked plainly, answered plainly

Has the extraction's accuracy been measured?
No accuracy has been measured, so none is claimed. Antevra checks that its own reasoning obeyed its rules, not that it is clinically correct, which is why every claim is cited and routed to a person before export.
Can we keep our protocol in-house?
The model backends are switchable, including a model you host yourself. No real patient data enters Antevra, by design.
What happens when a document changes?
Sources are revisions, never overwrites. Re-analysis is partial: findings whose evidence has not moved keep their decisions.
Who owns compliance?
You do, through your validated installation and your SOPs. Actora is built for the controls and ships a validation pack for the exact release you install.

Good tools, built for other jobs.

Each category does its own job well. The bars show the part of a study each one is built for; the line below says where we differ.

Protocol design platforms

Structured design, benchmarking

Antevra: works from your own protocol and documents, cites every claim, and holds export until people decide.

Synthetic data from past trials

Patients built from historical data

Antevra: data from your protocol's own design, the same from the same seed, with a validation report. No patient data.

General AI document tools

Prose summaries

Antevra: a record, not a summary: cited claims, a status set by rules, a named decision, a gate with no override.

General EDC

Multi-site Phase II–IV capture

Actora: built around the BE clinic: confinement, timed PK sampling, custody, IP accountability and blinding in one record.

Phase I eSource

Phase I units, US and Europe

Actora: designed for CDSCO-regulated BE CROs in India, one instance per customer, set-up as configuration.

Paper and spreadsheets

Familiar, low cost

Actora: captured as it happens, attributed and audited, with nothing to transcribe.

Astralith

Two products, one set of rules

Antevra before the trial, Actora during it, with a gap between: they are designed to connect, and that connection is on the roadmap.

A summary tells you what a document says. A record tells you who decided what, on what evidence.

Ask us to show any control working.We will walk through the validation pack on a synthetic study. Ask (opens in a new tab)