Pilot
Free
Try it, run a resident’s project or a small registry.
- 2 open studies
- 25 subjects per study
- 5 team members
- 30 document reads a day
The study workspace for veterinary research
Every animal, described exactly. Every change, on the record.
Set up a clinical or observational study in client-owned animals, enroll the subjects, let owners record from their phones, read scanned records into the forms, and hand over a database a monitor can verify.
- A study set up in about ten minutes
- Audit trail and signatures built to 21 CFR Part 11
- Owner identities kept apart from study data
What is in the box
Everything a field study needs, in one place.
Most veterinary studies still run on spreadsheets, paper consent forms and email. Human-trial software costs more than the study and knows nothing about owners, VCPRs or FDA’s Center for Veterinary Medicine. This is the workspace built for the clinic and the sponsor who works with it.
01
Protocol and consent
Versioned, with the regulatory questions asked up front: design, product supply, ethics review, consent. Every later change is a numbered version with a reason.
02
Case report forms
Enrollment, examinations, laboratory panels, dosing, concomitant medications, adverse events with the serious criteria of 21 CFR 514.3, deviations, end of study, owner check-ins. Add your own fields.
03
Owner participation
Invite an owner by email. They sign consent and record from their phone, and see only their own animal. Their identity lives in a key kept apart from study data.
04
Scanned records
Upload a PDF or a photo of a clinic record. The reader proposes lines with a source quote for each; a person accepts what is right, and the record shows its source.
05
Queries, verification, lock
Monitors raise queries, the site answers, investigators verify with a signature that re-checks their password, and the database locks with a fingerprint.
06
Exports and audit trail
CSV per form, a data dictionary, and a JSON bundle with the full hash-chained audit trail. A monitor can verify the chain without trusting us.
Who it is for
Three kinds of study team.
Sponsors
Pet health products
Supplements, nutraceuticals, diets and devices running field studies in client-owned dogs and cats, for a claim, a publication or a submission. Data that survive a monitor, a reviewer or an FDA question, at a tenth of the price of human-trial software.
Practices
Specialty and referral hospitals
Sponsor trials, internal outcome tracking and registries in orthopaedics, oncology, dermatology and rehabilitation. One place for the coordinator; GCP-grade records for the sponsor; a registry that becomes a paper.
Universities
Clinical trial offices
Many small studies, residents’ projects and IACUC-reviewed client-owned animal studies. Consent signed online, owners recording at home, a locked, exportable database for the thesis, and no server for IT to run.
How it works
Five steps from an idea to a locked database.
Open a workspace
Your practice, department or company. Invite investigators, coordinators, monitors and viewers with the access each one needs.
Set up the study
Start from a template: a 90-day observational study, a 12-week mobility trial, a registry, or blank. The protocol, schedule, forms and consent text come filled in.
Activate with a signature
Confirm the approvals the design needs and sign. The attestations and the signature are on the record.
Enroll and record
Subject codes, not names. Owners record at home, the site records at visits, scanned records become sourced lines.
Verify, lock, export
Answer the queries, verify the records, lock the database, and hand over exports whose chains verify.
Built for the rules you work under
Honest about the law.
The guide inside the workspace says what an INAD file, an IACUC review, VICH GL9 and 21 CFR Part 11 mean for your design. The filings stay yours; the records are built to hold up.
What the system does
- Audit trail: append-only, hash-chained per workspace, with who, what, when and why (21 CFR 11.10(e))
- Electronic signatures that re-check the password and bind to the hash of what was signed (11.50, 11.70, 11.200)
- Access by role; monitors and viewers never see owner identities (11.10(d))
- Idle sign-out and password-age policies per workspace (11.300)
- Adverse events with the serious criteria of 21 CFR 514.3 and ABON causality
- Protocol, consent and form versioning with reasons; pseudonymous exports with a data dictionary
- Owner identity kept apart from study data; California service-provider terms; GDPR Article 28 terms on request
What stays yours
- The INAD file, or the confirmation that your design needs none
- Ethics (IACUC or equivalent) review
- The content of the informed consent and the veterinarian–client–patient relationship
- Adverse-event reporting to the sponsor and regulator on the protocol’s timelines
- Training, standard operating procedures and validation for your intended use
- Your organization’s Part 11 certification letter to FDA (the workspace records its date)
- Records retention after a study closes: export and keep copies
Signalment is a data system. It never claims a product is safe or effective, never embeds a licensed questionnaire without permission, and says in plain words which filings stay yours.
Plans
Start free. Grow when the study does.
Prices in US dollars, per workspace, billed monthly and cancellable any time. A workspace is a practice, department or company; it can run several studies.
Practice
$149a month
A practice or a department running trials.
- 5 open studies
- 100 subjects per study
- 15 team members
- 200 document reads a day
Institution
$499a month
A university clinical trials office or a sponsor.
- 25 open studies
- 1,000 subjects per study
- 50 team members
- 1,000 document reads a day
Enterprise
By agreement
Multi-site programmes, single sign-on, a signed quality agreement and a named contact.
- Unlimited studies
- Sites and sponsors in one workspace
- Quality agreement and audit support
- Priority support
Questions researchers ask
Plain answers.
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 what was signed; access by role; exports; and a validation summary and test suite you can read. Compliance is a property of a study, not of software alone: your organization keeps its procedures, training records and its certification letter to FDA, and the workspace settings help you record them.
We use REDCap. Why change?
Keep REDCap for surveys if you like. Signalment adds what field studies in client-owned animals need and REDCap does not do on its own: owner participation with consent from a phone, scanned records read into forms, hash-chained records and a lock with a fingerprint, with no server to run.
Where are the data?
On Cloudflare’s network in United States data centers, encrypted in transit and at rest. Owner identities are held in a key apart from study data and never leave with a pseudonymous export. The data processing addendum lists every sub-processor.
Does it include the CBPI, LOAD or other validated instruments?
No. Licensed instruments are added by you under your own licence as custom forms. The templates use plain, study-defined scales so that you never publish on an instrument you did not license.
Can owners really do this?
They get an email, tap a link, sign the consent and record a check-in in under a minute from the phone they already have. Paper consent can be recorded too, with the scanned form attached.
What does it cost?
Pilot is free: two open studies, twenty-five subjects each, five team members. Practice is $149 a month and Institution $499 a month, billed through Stripe and cancellable any time. Enterprise programmes are priced by agreement.
Why is it called Signalment?
A signalment is the first line of every veterinary record: species, breed, sex, age. The animal, described exactly. That is the standard the whole study is held to.
Twenty minutes
See it with your own study.
On a call we open a workspace, set up your study from a template, invite an owner to your own phone, sign, record, raise a query, verify, lock and export. Then the workspace is yours to keep on the free plan.
- For sponsors: a pre-launch review of your data plan against the templates
- For practices: your coordinator’s workflow, end to end
- For universities: a department pilot with hands-on setup of the first study
Provided under the service terms, the data processing addendum and the privacy notice.