Made by Perpetua AI
Vigía reads the protocol and builds the study. It checks each entry at the point of care, then signs, bills and reconciles from the same record.
Screens and the demo show synthetic data. The prototype needs a password.
Animated example from the prototype. A coordinator types 720 minutes to centrifuge. The Guardian asks whether she meant 72. She accepts, and the value is recorded, flagged as above the 60-minute limit. Consent is current and the task is delegated. Dosing waits, with the reason: pre-dose assessments are not complete.
Designed around
The coordinator typed 720 minutes to centrifuge. Vigía asks whether she meant 72, and holds dosing until the pre-dose steps are done. Pick a pin to see the rule and where it comes from.
Coordinators spend their days re-reading protocols and re-typing values across systems. Vigía takes that work off their desk and leaves every decision with the people accountable for it.
Someone reads every page of the protocol and keeps the rules in their head.
Vigía reads it and cites where each value came from.
The study is built by hand, and every value is typed twice.
Confirm each value once and the study is built, rules already in place.
Mistakes surface at the monitoring visit, weeks later.
The Guardian catches them at the point of care, while they can still be fixed.
A value confirmed during the build is the value the Guardian checks at the visit, the investigator signs, and the sponsor is billed for.
Protocol, amendments, lab manual and CTA budget become a requirement registry. Each requirement cites the page that states it; one Vigía can’t find is marked uncited. When sources disagree, an investigator decides, with a reason.
Schedule of activities, visit windows by cohort, eligibility, prohibited medications and budget. A person confirms each value before it goes live.
Every value confirmed by a person before the study goes live.
Paper or eConsent, in person or remote. Only the IRB-approved version for that language, with witness, legal representative and minors handled as the IRB ruled.
eSource at the point of care. Dosing waits for the pre-dose steps. Delegation and training are checked at the moment of each act. Corrections keep the original.
Signatures carry name, time and meaning and are bound to the exact record. Change it afterwards and the signature shows as broken.
Completed work earns its fee at the price in force on the day it was done. Invoices, payments and holdback reconcile to the cent.
An amendment gets an impact plan, participant by participant, before anything moves. The investigator approves and signs; follow-up work is waiting.
Monitors and inspectors get scoped, time-limited access to their studies. Certified copies, a structured export and the full audit trail are ready to hand over.
Append-only, hash-chained audit trail. Certified copies and a structured export are ready to hand over.
Change the processing time. The Guardian checks it against this study’s own limit as it’s typed, and shows the page the limit came from.
Because it has read the protocol, Vigía can tell whether what’s happening now is right, and show you why.
Windows, procedures, limits and fees carry their source: document, version, page and quoted text where the document is registered. When the protocol and the lab manual disagree, Vigía won’t pick one.
51 rules run while the work happens, instead of in a monitoring visit weeks later. Each holds what must wait and records what happened, with the reason.
Vigía reads lab reports, budgets and protocols and drafts the values. Nothing becomes a record until a qualified person confirms it, and the AI’s proposal is kept beside what the person entered.
A visit completed once updates the schedule, the EDC queue and the ledger. No exports between the site’s own tools, no second copy to reconcile.
Before a protocol change takes effect, Vigía shows what it will do to each participant. If a record changes after approval, activation is refused until the plan is reviewed again.
An append-only, hash-chained audit trail, Part 11 signatures bound to their records, and validation templates (requirements, risk assessment, IQ/OQ/PQ protocols, traceability to tests) to support your own validation.
Five minutes, recorded from the working product. Choose a chapter to jump straight to it.
Recorded when the Guardian had 44 rules; it has 51 today.
Every clinical trial begins with a protocol, and a person who has to read every page of it. Then someone builds the study by hand, types every value twice, and remembers every rule. Miss one step, and the study pays for it. What if the software did the reading, the typing, and the remembering? Meet Vigía. The AI operating system for clinical trial sites. From Perpetua AI.
It starts where every study starts. Hand it the protocol, and Vigía reads it, page by page. Nine visits and sixteen procedures, with every window and fasting rule, become a schedule of activities. Nine eligibility criteria. Three classes of prohibited medication. The budget. Each value cites the page it came from. It even prices the study against your site’s own costs. Confirm each value, and the study is built, its Guardian rules already in place.
At the visit, Vigía checks every value as it’s entered. Seven hundred and twenty minutes to centrifuge? Did you mean seventy-two? The dose stays on hold until the pre-dose steps are done, and it cites the rule that says so. Forty-four rules, watching every act at the point of care. It stops the mistake, never the record.
Every rule traces back to the page that wrote it. When the protocol and the lab manual disagree, Vigía won’t pick one. An investigator decides, and says why. And when the protocol changes, Vigía shows what the amendment will do, participant by participant, before anything moves. A booking that no longer fits. A visit already underway. A participant whose cohort was never recorded. Each one, with its reason. The investigator approves the plan, and signs. The follow-up work is already waiting.
And no one types what’s already written. Take a photo of the paper worksheet. Every value is read, placed in its field, and linked to the box it came from. Or just say it out loud. Coordinator: Seated five minutes. Pressure one twenty-six over eighty. Pulse seventy. Temperature thirty-six point seven. Vigía reads the lab report, and catches what the report missed: a potassium of five point nine, above range, and unflagged. Every value carries its source, and nothing is saved until a person confirms it.
A coordinator writes, in Spanish: se cayó, fue a emergencias. Vigía recognizes a possible adverse event, flags the emergency visit for a seriousness call, and drafts it for the investigator. The serious-event clock runs from the moment the site knew.
Every morning, Autopilot has the day’s work prepared: query answers drafted from source, visits to book, invoices to draft. Each item shows its evidence. You approve it with one click. And you can simply ask. Which studies are behind on enrollment? Which sponsor is slowest to pay? Every answer links to the records behind it.
Vigía follows every dollar, from finished visit to cash. Forty-six thousand dollars of finished work, not yet invoiced: drafted in one click. A sponsor skipped three visit fees. Vigía caught it, and wrote the dispute letter. Hand it the contract, and it reads the budget, and flags a total that doesn’t add up.
And the books balance, to the cent. Every fee is priced by the budget in force on the day the work was done. Write-offs, and reopening a closed month, take a second person. Twelve financial reports carry the checks that prove them, and go to your accountant in Excel.
Insights finds what nobody has time to look for: morning vital signs draw queries at four point seven times the site’s rate. Open it, and there are the records behind it.
Consent in the participant’s own language. Amendments that re-plan the visits not yet started. Investigational product, accounted for kit by kit. Part eleven electronic signatures. A regulatory binder that tracks its own expirations. One system. One record. The entire site.
Built with HIPAA’s safeguards at its core: sensitive fields encrypted, every change sealed in a hash chain, every signature re-authenticated. Alter a single character, and the chain shows exactly where. AI runs through a gateway covered by a business associate agreement, and nothing a model returns is saved until a person confirms it.
And every value has a known origin. Each device, instrument and lab system that sends data is on the study’s authorized list. And the investigator signs how the data flows, from capture to the sponsor.
Read, not re-typed. Caught before it happens. Billed when it’s done. Vigía. The AI operating system for clinical trial sites. Built by Perpetua AI.
Real screens from the prototype. Scheduling, eSource, eConsent, the regulatory binder, investigational product, participant payments and billing share one record.
Revenue comes from the clinical record, not a spreadsheet kept on the side. One ledger feeds every money screen and checks itself every time it’s read.
A completed visit earns its fee; a visit where nothing was done earns nothing. Start-up, IRB, annual and close-out fees are earned when their event happens.
Every fee comes from the budget version in force on the day the work was done, even when an amendment is entered late.
A coverage analysis marks each procedure sponsor-paid or standard of care. Standard-of-care items go to the billing office with the NCT number and modifier Q1.
Withheld amounts are tracked per line and billed on a holdback invoice at close-out.
Write-offs, reopening a closed month and off-schedule participant payments need a second person. Corrections are new lines, never edits.
A fingerprinted snapshot of earned, unbilled, receivables and cash, with a journal export for your accountant.
Paid from the IRB-approved schedule, with yearly totals per person and the IRS reporting threshold for each tax year.
Uses your own staff rates and overhead. Until you enter them, Vigía says “not set” instead of guessing.
Pick a period, a basis and a comparison. Every report reads the same ledger, shows the checks that tie it to the books, and hands your accountant a file.
FDA’s guidance on electronic source data calls for a list of every person, device, instrument and system authorized to originate source data, and a description of how the data flows to the sponsor. Vigía keeps the site’s side of both current, and the investigator signs it.
People come straight from the delegation log, with the tasks each may do
LiveDevices and systems are registered with the identifiers they send and their qualification
RegisteredDevice files are read only from a registered device, never guessed
RefusedLab results from a sender not on the list are kept, and flagged
FlaggedThe data flow shows itself out of date when the study or the list changes
Re-signThe investigator signs the list and the data flow
Signed
The data-flow description is built from the study’s visits, its originators and its EDC settings: what is captured, by whom, where the source record is, who reviews it and how it reaches the EDC.
The investigator approves the exact version reviewed, with re-authentication. Earlier versions are kept with their content and fingerprint.
Each device reading carries the device that produced it and the person who confirmed it, on the date it was authorized.
The originator list and the signed data flow go into the archive and the dataset export, ready for a monitor or an inspector.
Designed around ICH E6(R3), adopted by ICH in January 2025 and published by FDA as final guidance in September 2025, and around 21 CFR Parts 11, 50, 54, 56 and 312.
The prototype runs in your browser on fictional studies with synthetic participants. Nothing to install. It needs a password.