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One shared record for each study.

Most of the coordination on a study happens in email and attachments. The portal puts the contract, the timeline, the updates and the files in one place that both sides can see. It emails each side when the other does something.

The problem

A study run over email has no single record.

The sponsor’s spec is a PDF proposal. The status is whatever the last weekly email said. Files arrive as attachments with the same names as last week’s, and a missing column is found after delivery.

The portal changes where the study’s paperwork is kept. The science is done the same way as before.

What the portal does

Three parts, each written down once.

The contract comes before the study, the record is kept during it, and the deliverables come at the end. Both sides read the same copy of each.

  • The contract

    before the study

    The terms, the design table, and the checklist of deliverables, with the columns each file must have. The sponsor locks it.

  • The record

    during the study

    Milestones, updates, the animals registered to each group, and every notice that was sent.

  • The deliverables

    at the end

    Every upload is kept as a version and checked on the way in. The sponsor accepts it or sends it back with a note.

The checks

Every file is checked when it is uploaded.

The sponsor says which columns a table must have. The portal checks every upload against that.

  • Every named column is present
  • Every animal in the file is registered on the study
  • Each group has one row per animal still on study, at each timepoint
  • The control group’s values are within the agreed range
  • The check results are saved with that version, and the CRO sees them first
  • A file that passes goes to the sponsor, who accepts it or sends it back
  • A report with no shape is never read

The CRO fixes the file and uploads it again. The sponsor only sees files that passed.

tumour-volumes · shape
{
  "columns": ["animal_id", "group", "day", "tumor_volume"],
  "subject_column": "animal_id",
  "group_column": "group",
  "timepoint_column": "day",
  "control": {
    "group": "G1",
    "column": "tumor_volume",
    "min": 80,
    "max": 120
  }
}

How a study runs

The sponsor sets up the study, the CRO runs it, and both can see everything.

  1. 01

    Open

    The sponsor creates the study, adds its CRO, and writes the contract. The contract lists the files the CRO will deliver and the columns each must have.

  2. 02

    Run

    The CRO keeps the timeline up to date and posts updates on the agreed schedule. A death, a deviation or a dose excursion has its own update type, and the email subject names it.

  3. 03

    Deliver

    Files upload from the browser straight to storage and are checked on the way in. Each one appears on the checklist, and the sponsor accepts it or sends it back. Every step is logged.

For CROs

Nothing to install, and a track record you build up.

A CRO signs up once. After that, any sponsor can add it to a study. Every event arrives by email with a link, so nobody has to log in to find out what happened.

The portal counts every study a CRO delivers, by study type and species. Sponsors can read that track record. It never names the sponsor.

A server and a database, drawn in isometric projection, standing together.

Start with one study.

Set up your organisation, create a study, and write the contract. After that, you decide whether to keep going.

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