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Cori for sponsors

A small team, running the study like a large one.

Design, documents, submissions and amendments work from the living blueprint of your clinical trial, enriched with trusted external sources. Cori drafts and checks. Your team decides.

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Study CORI-2291

Startup · before first participant in

On track
4 workstreams2 open findingsOwner: VP Clinical Operations
Workstream progress for study CORI-2291
Protocol v3.1Authored and reviewed, 2 open findings
86%
Informed consent form, 6 languagesWritten from the protocol, in sync
100%
Submission pack, EU4 of 5 stages ready, CTIS
78%
Amendment 01Impact mapped across 4 documents
40%

Example study. On a real one, every number traces back to the person, import or model that produced it.

What changes

One copy of each document to chase. Every decision on record.

  • Modifications/Amendments

    Without Cori
    Each document re-edited by hand, and one copy gets missed.
    With Cori
    Everything the change touches is listed before you commit, then the affected sections are redrafted.

  • Oversight

    Without Cori
    Decisions buried in email threads.
    With Cori
    Each decision saved with its evidence and the person who approved it.

  • Team

    Without Cori
    Headcount grows with the portfolio.
    With Cori
    A lean team runs the trial.
A protocol section being authored in Cori, with a tracked edit, a suggestion showing the protocol paragraph it was drawn from, and a reviewer's comment against the same passage.
A suggested edit arrives with the passage it was drawn from, and your reviewer answers it in the same place.Sample study

Design to amendment

Decide once, and the rest follows.

Design and cost

See what a design costs while it is still a choice

Compare options on duration, cost and site burden. The budget is projected from the Schedule of Assessments and moves when the design does.

SCHEDULE OF ASSESSMENTSV1V2V3V4V5V6V7V8Physical examVital signsLabsECGImagingQoLA · 24 moB · 21 moC · 18 mo4 fewer assessments, cost updated
Sample study

Regulatory package

Every country pack drafted from the same protocol

The consent form, synopsis and country packs follow the protocol, and gaps are named while there is time to close them.

PROTOCOL FIRST, THEN THE RESTProtocolConsent formSynopsisCover letterCOUNTRY PACKSPLTranslatedESTranslatedDETranslatedCZTranslatedREADYProtocol, submission documents, 4 country packs

Modifications/Amendments

Change it once, and see everything it touches first

Before you commit, Cori lists every document, budget line and date the amendment affects. Once it is approved, Cori redrafts them.

Protocol6 sectionsConsent formRedraftedSoA2 visits addedBudget+ EUR 214kTimelineFPI + 2 weeksCountry packs3 to refileMODIFICATION/AMENDMENTEndpoint addedAPPROVEDAffected sections redrafted
See how it works in full

Oversight

A record you can hand an inspector.

It asks instead of inventing

When Cori cannot ground a section in your sources, it asks the person who knows.

Every action logged

If a log entry is ever altered, it shows.

A grid of study facts in Cori checked across the protocol, the Schedule of Assessments, the consent form, the budget and the analysis plan, with three of them flagged where the documents disagree.
The same fact, checked across every document that states it, and re-checked whenever any of them changes.Sample study

In only thirty minutes

See what a leaner trial looks like on your own study.

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