Built for clinical research sites and site networks
Every study is its own rulebook, and your coordinators run several at once
A research coordinator holds multiple protocols simultaneously, each with its own visit windows, its own sample handling, its own reporting timelines — and each amended on the sponsor's schedule. The failure mode is not ignorance, it is interference: applying study A's procedure while working on study B.
What actually breaks
Amendments supersede and the old version stays in circulation
A protocol amendment arrives and is filed correctly. The printed copy in the coordinator's binder does not change, and neither does the version they have internalised. Versioning here is not an administrative nicety, it is the thing a monitor writes findings about.
Study-specific procedures blur together
Sample processing, temperature handling, visit windows and permitted deviations differ per protocol, and a coordinator running four studies is relying on memory to keep four sets straight during a visit that is already running behind.
Delegation and training records are checked at the worst time
Who is delegated to perform which task, and whether their training is current for the current version, is a question that gets asked properly during a monitoring visit and informally never.
The documents this covers
- Protocols and amendment histories
- Study-specific manuals of procedure
- Delegation of authority logs
- Sample handling and shipping instructions
- Informed consent versions by study
- Standard operating procedures for the site
Who feels it
- Site director
- Clinical research coordinators
- Regulatory specialist
- Principal investigators
Why a governed corpus matters here
Research sites handle protected health information and are audited on document control specifically — which version was in effect, who was trained on it, when. That makes the boring metadata the valuable part: a retrieval layer that cannot tell a coordinator which version it answered from is not usable here.
Questions we get asked
Can it tell coordinators which protocol version an answer came from?
Yes — every answer cites the document it came from, and documents carry the date they were last verified. For this industry that provenance is more important than the answer text.
Does it replace our eTMF or CTMS?
No. Those are systems of record and should stay that way. This sits in front of them and answers the question, which is a different job — most sites have bought the first and assumed it did the second.
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