Every study document, versioned.
The protocol, manuals, consent forms and amendments live in one registry, so the site knows which version is in force.
- Protocol and amendments
- Pharmacy manual
- Laboratory manual
- Consent forms
LIND47 turns a trial protocol and its manuals into your site's daily work, with every action traced to its source page.
Pre-launch. Built by a principal investigator. Seeking the first research sites.
6.1 SCHEDULE OF ACTIVITIES Screening occurs within 28 days before Cycle 1 Day 1. Study drug is given on Day 1 of each 21-day cycle. A complete blood count is collected before each dose.
The trial is designed elsewhere and executed at the site. LIND47 is one system for all your studies, whoever the sponsor. It does not replace the sponsor's EDC or IRT.
of protocols are amended at least once, and the site has to absorb every change. Getz et al., Ther Innov Regul Sci, 2024
“I have run trials where the protocol lived in a PDF and the operation lived in spreadsheets, vendor portals and memory. Every year brings more documents and more systems to fill in. LIND47 is the one system I wanted for my whole team.”
Six stages, illustrated with synthetic data.
The protocol, manuals, consent forms and amendments live in one registry, so the site knows which version is in force.
Visits, procedures and eligibility criteria are extracted as structured facts, each pointing to its page. Contradictions are flagged, not guessed.
| Procedure | SCR | C1D1 | C1D8 | C2D1 | EOT |
|---|---|---|---|---|---|
| Informed consent | X | ||||
| Physical exam | X | X | X | X | |
| Complete blood count | X | X | X | X | X |
| Study drug | X | X | |||
| PK sample | X | X |
The study team reviews facts beside their source. The package is published only after approval and electronic signature.
"Screening occurs within 28 days before Cycle 1 Day 1."Protocol v3.0 · §6.1 · p. 41
Visit windows, tasks, pharmacy and lab queues come from the published package. If a rule is not met, the task is held for a person to resolve.
Each event is recorded with the package version and the source page behind it.
A new amendment is compared with the package in force. The site sees which facts changed and what follows for consent, training and visits.
What the package drives, role by role.
Today's agenda, visit windows, due tasks, pharmacy and lab queues.
Enrollment, deviations and site health at a glance.
Preparation, dispensing, accountability and temperature log.
Kits, collections, specimen custody and shipping.
Site file completeness, deviations and CAPA.
A read-only remote view of coded records.
Each one links to a document, version and page.
Only signed packages reach daily work.
AI proposes. People review, approve and sign.
It fails closed and asks a person.
Design references, not certifications: ICH E6(R3), 21 CFR Part 11, LGPD.
Protocols, manuals and cited facts. No participant data.
Packages, visits, tasks, inventory.
Participant records, in a separate database.
Not yet commercially available, and not yet independently validated.
We are looking for a few research centers for the first evaluations. Tell us about your center and we will scope the evaluation together.
You will hear back from the founder.