The regulatory binder, without the binder.
Sites keep essential documents in a physical binder because that is what the process grew up around — tabs, dividers, wet ink, and a monitor who has to be in the room. An electronic binder keeps the structure and removes the need to be there.
- Tabbed structure
- Remote access
- Signatures
- Always current
- Sections in the index
- 24
- Filed and current
- 23
- Awaiting document
- 1
- Monitor access
- Remote
- Last opened by CRA
- 2 days ago
Visible to the monitor without a site visit.
Know what is in the binder without being at the site.
A paper binder answers questions only to whoever is standing in front of it. An electronic one answers them to the monitor, from anywhere — and paired with the eISF tracker it becomes a status view.
Check before you travel
Confirm what is filed, current and outstanding days before a visit, from anywhere.
The tracker says what is missing
The binder holds documents, the eISF tracker holds the expectation — together, what should be there.
Sites stop re-sending documents
No scanning and emailing a page the monitor could not see. It is already there, current version.
One filing, both files
A document needed in both the site file and the TMF is filed once and indexed in both.
Gaps surface between visits
An expiring CV or lapsed certificate shows while it is still fixable, not as a finding.
Time back on both sides
Less chasing for the CRA, fewer interruptions for the coordinator.
A binder sites will actually work in.
The organising structure sites already know, with the properties paper cannot have.
Tabbed sections
The familiar binder structure, configured per study rather than assumed.
Unambiguous versions
The current document is explicit; superseded ones are retained but clearly marked.
Electronic signature
Signatures captured with actor and timestamp instead of wet ink and a courier.
Gaps are visible
An empty section is distinguishable from a section whose document is not yet due.
Remote review
Monitors open the binder without travelling, and the site sees who accessed what.
One filing, two indexes
Documents required in both the site file and the TMF are filed once.
Connected in the same platform
Bring a binder you'd rather not carry.
30 minutes with a founder. We'll set up an electronic binder for one of your studies and show what a monitor sees when they open it remotely.