Questions

Questions study teams ask.

Plain answers about setting up a study, owners, compliance, data and pricing. If yours is not here, ask it on a demo or email hello@signalment.app.

The product

What is Signalment?

Electronic data capture for veterinary field studies in client-owned animals. Case report forms, an owner app with eConsent, randomization and blinding, data checks, queries, source verification, sign-off, an audit trail and exports, in one workspace. Coordinators, investigators, assessors, monitors and sponsors each work in it with the access their role allows.

How is a study set up?

Start from a template (a 90-day observational study, a 12-week mobility trial, a 12-week treatment-outcomes study, a registry, or blank) and change the forms, visit schedule, consent and randomization to fit your protocol. Activation is a signature, with the approvals the design needs on the record. There is no implementation project; on a demo we show how your study would be set up.

Do owners need to install an app?

No. The invitation email opens the owner’s side in the phone’s browser, and it can be added to the home screen. Owners sign consent, answer check-ins one question per screen and add photos. Each owner sees only their own animal. Paper consent can be recorded too, with the scanned form attached.

Does it include the CBPI, LOAD or other licensed instruments?

No. Licensed instruments are added by you, under your own license, as custom forms. The templates use plain, study-defined scales so that you never publish on an instrument you did not license.

Does Signalment use AI?

Only if a workspace owner turns on the Signalment Assistant; it is off by default, and each of its tasks can be turned off on its own. When it is on, it drafts a study’s forms, visit schedule, consent and data checks from the protocol, reads the protocol and consent for what is missing or unclear, reads an uploaded clinic record or lab report into proposed lines, and suggests VeDDRA terms for adverse events. A person accepts or rejects every proposal, and the audit trail keeps which model made it. A document it reads is sent to Anthropic for processing, under terms that do not permit training on it.

Does it manage study supplies and devices?

Yes, as a module a study turns on. It counts product by component and lot at the depot and every clinic, works out what each dog has at home from the dose table and what was handed over, and says the day each site runs out. Shipments are built from those needs in four steps, with the carriers’ rates and labels from a connected shipping account, a packing slip and a receipt that puts the stock on the clinic’s shelf. Coded kits and devices such as activity collars are tracked to the dog and back, with a prepaid return label for the owner.

What is not built yet?

SEND datasets, single sign-on through your own identity provider (SAML) and a public API. If your study needs one of them, say so when you book a demo; it changes the order we build in.

Compliance and data

Is Signalment 21 CFR Part 11 compliant?

It is built to Part 11: an append-only audit trail that records who, what, when and why; electronic signatures that re-check the signer’s password and bind to the version signed; access by role and by site; and exports. Compliance is a property of a study, not of software alone. Your organization keeps its procedures, training records and its certification letter to FDA. How the records are kept.

What do we get for a quality agreement or an audit?

The validation package (plan, user requirements, risk assessment, test protocol and report, traceability matrix, summary report and SOPs), the data processing addendum listing every sub-processor, and exports whose audit chain anyone can verify. Enterprise adds a signed quality agreement and a named contact.

Where are the data kept?

On Cloudflare’s network, stored in United States data centers, encrypted in transit and at rest. Owner identities are held apart from study data and never leave with a pseudonymous export. The data processing addendum lists every sub-processor.

Who can see owners’ names?

Workspace owners, investigators and coordinators, and a coordinator limited to one site sees only that site’s owners. Monitors, assessors and viewers, including a sponsor’s viewer, never see owner identities. Every record and export uses subject codes.

How does blinding work?

Arm labels and allocations are shown only to members marked unblinded, such as the pharmacist who prepares coded kits. Blinded staff see an allocation number or a kit code. Breaking the blind for one animal takes a reason and the person’s password, and it is on the audit trail.

Choosing Signalment

We use REDCap. Why change?

You may not need to. REDCap has surveys, a participant app, an e-Consent framework and a randomization module, and a team that knows it can build a client-owned study on them. Signalment arrives with that study built for owners and animals: the owner app and eConsent, randomization with coded kits and a logged code break, hash-chained records and a lock with a fingerprint, with no server to run. Keep REDCap for what it already does for you. A longer comparison.

We already have an enterprise EDC.

Keep it where it serves you. Some teams try a smaller field study or a pilot in a free workspace and compare the exports. Pricing is per workspace, with no per-study fee, and the exports are open: one CSV per form, a data dictionary, a SAS program and a signed JSON bundle.

What does it cost?

The Pilot plan is free: 2 open studies, 25 subjects per study, 5 team members. Practice is $149 a month and Institution $499 a month, billed monthly and cancellable any time. There are no per-study or implementation fees. Enterprise is priced by agreement. Compare the plans.

Who answers when we need help?

The team that builds Signalment. Email hello@signalment.app; Enterprise workspaces get a named contact.

Ask it on a demo.

A 20-minute walkthrough, set around your study, with the team that builds Signalment.