Xerum for pharma and regulated R&D teams
The rationale is as regulated as the result
Why a protocol was amended, what the discussion weighed, who signed off — all of it has to be traceable, and none of it lives in the system that holds the result. It lives in threads, decks and meeting notes, which is exactly the layer nobody has made auditable.
Sound familiar?
The decision is documented, the reasoning is not
An amendment is recorded. The debate that led to it — the alternative considered and rejected, and on what evidence — is in correspondence, and reconstructing it later is a project.
Assistants are unusable without traceability
A model that summarises internal discussion but cannot say which document, which version and which author is not something you can put into a regulated workflow, however good the summary is.
Approval trails live in a second system
The knowledge is in one place and the sign-off in another, so every audit is a reconciliation exercise between two systems that were never designed to agree.
What changes
Approval is part of the record
Members propose, owners decide — and an approved proposal's changes join the same history as everything else. The sign-off and the content are one trail, not two.
Nothing edited in place
Every version of every resource is retained by construction. There is no overwrite path to control, because there is no overwrite path.
Answers carry their source
Provenance ends at the origin: which document, which revision, which author, and the URL. A summary can always be walked back to what it summarised.
Isolated per organisation
Own container, own database, own storage prefix. The deployment story your quality and IT functions already ask for, rather than an exception you have to argue.
What this industry buys
Audit + curation
Two properties your existing quality culture already has words for — implemented as how the store works rather than as a procedure people follow.
- Every change: what, by whom, when, and why
- Approval by an owner before anything joins the history
- Any revision readable, so "as of the amendment" is a query
- One instance per organisation, replicated to its own prefix
Xerum is infrastructure for your discussion layer. It makes no regulatory claim and is not a validated system of record for trial data.
Related
Make the discussion layer as traceable as the data
Built today, not on a roadmap. Every property above is already how the store works.