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Bijection for Clinical Trials

Every visit on schedule. Every document, the right version.

Studies, sites, participants and documents in one record, with every visit and every document version tracked.

A study team tracks sites in one system, participant visits in another and essential documents in a shared drive, then reconciles them in spreadsheets before each monitoring visit. A missed visit window is often noticed weeks later.

Bijection links studies, sites, participants, visits and documents into one record. Each document enters as an immutable version, visit windows are dates the system acts on, and every deviation, approval and signature is recorded with its author.

  • Site activation

    Starts: A site is selected for a study

    1. List the documents and approvals the site still needs.
    2. Each item waits for its owner.
    3. The site opens for enrolment once every item is in.

  • Visit windows

    Starts: A participant’s next visit is due

    1. Remind the site before the window opens.
    2. Wait for the visit to be recorded.
    3. A missed window opens a deviation for review.

  • Protocol amendments

    Starts: A new protocol version is approved

    1. List the sites and documents it affects.
    2. Send the updated documents for signature through DocuSign.
    3. Each site moves to the new version once it has signed.

  • Monitoring visits

    Starts: A monitoring visit is scheduled

    1. Assemble the site’s open deviations, missing documents and recent visits.
    2. The monitor records findings.
    3. Each finding stays open with an owner until it is resolved.

  • Safety reports

    Starts: A site reports a serious adverse event

    1. Open the case with the participant’s visits attached.
    2. Track the reporting deadline.
    3. The safety lead reviews it before it is submitted.

  • Document expiry

    Starts: A site document is about to expire

    1. Ask the site for the renewed document.
    2. The request waits until it arrives.
    3. The new version replaces the old one, which is kept.

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