Outsourced publishing has a hand-off at its centre. The publisher assembles a sequence; the sponsor has to confirm what goes in it. Which documents, in which sections, which ones are new and which replace something already filed.

In most engagements that confirmation lives in email. The publisher sends a spreadsheet. The sponsor replies with comments in the body of the message, or in a marked-up attachment, or both. The publisher reads them, interprets them and re-keys them. Then the cycle repeats.

It works, mostly. But nobody can say at any moment whether the sponsor has opened the plan, how far they have got, or which of their comments has been acted on. And when something goes wrong — a document replaced the wrong earlier version — tracing how it happened means reading an email thread backwards.

Give the client the plan itself

DnXT’s client collaboration replaces the spreadsheet with the plan itself, shared by secure link.

  • The plan is built from the sequence. One action adds the documents being assembled to the plan, each in its CTD section, with the lifecycle operation proposed from what has been filed before.
  • The client signs in with a one-time code. No account to set up, nothing to install.
  • Each row is confirmed, or flagged with a note. The client sees what each document is, where it goes and whether it is new or replaces something.
  • The client checks the details on file. Application number and type, applicant, products, substances, indications and contacts are shown back for confirmation — so an error in the dossier is caught by the person most likely to spot it.

Know where it stands

Beside the plan, the publishing team sees who has it, when it was sent, whether it was opened, when the client was last active and how many rows are confirmed. When the client has confirmed or flagged every row, the team gets one email and an in-app notice listing what was confirmed, what was flagged and the client’s notes.

That alone removes a surprising amount of friction. “Have you had a chance to look?” emails stop, because the answer is visible.

Feedback becomes the change

The most time-consuming part of the old process is interpreting comments. “Please replace the earlier protocol with this one.” Which earlier protocol? There may be several versions in force across earlier sequences.

DnXT matches each note against the filed history. When the history gives exactly one answer, the change is applied and the row goes back to the client to confirm. When it does not — an investigator’s brochure with several versions in force, two consent forms, two protocols — the candidates go to the publishing team to decide. The system never guesses.

Check the plan against the sequence

Before publishing, every row of the confirmed plan is compared with the sequence: placed correctly, placed in the wrong section, placed with the wrong operation, not placed yet, or still waiting for its document. Anything in the sequence that the plan does not account for is listed too. The publisher can then apply the outstanding rows after a preview of exactly what each one will do.

Deliver it the same way

When the sequence is published, it is sent back through the same portal. The client downloads the same package the publisher would have exported, and every download is recorded. No file-transfer links, no uncertainty about which version was sent.

Rules that keep the record clean

  • Nothing is written to the dossier from outside. A client’s correction becomes a proposed answer for the team; only the team changes the record.
  • Ambiguity goes to a person. When a note could mean more than one thing, people decide.
  • Every step is audited. Sending, confirmations, feedback applied and documents linked are all in the audit trail.

For publishing partners and CROs, this turns the sponsor hand-off from the least controlled part of the engagement into one of the best documented. For sponsors, it means reviewing your own submission in a clear view, with your notes acted on rather than re-typed. DnXT’s own publishing services run on exactly this workflow.

DnXT builds eCTD publishing, submission planning, document management and dossier review software for regulatory operations teams. Book a demo to see a submission plan go from assembly to client confirmation to delivery.