Clinical Development History — What the Agency Asked, and Where You Answered
What Did the Agency Ask? Word for Word.
Read any application’s filed history as a clinical development timeline — protocol versions, agency letters and clinical holds — with every agency request in the agency’s own words, linked to the response that answered it.
Your regulatory history is in the submissions. Finding it is the hard part.
When a new team member joins a programme, or a meeting package is due, someone has to answer the same questions: how did the protocol evolve, what has the agency raised, which hold issues were answered and where, and what is still open.
Those answers are all in the filed sequences. In most companies they are reconstructed by hand, from a viewer and a spreadsheet, every time someone asks.
DnXT Reviewer builds the history directly from what you filed.
Built for the people who own the outcome
Clinical and regulatory leads
See the whole development story of an IND or NDA in one place before a meeting, without opening thirty sequences.
Regulatory writers
Find the agency’s exact wording and the response that addressed it, ready to cite in the next briefing document.
Due diligence and in-licensing teams
Understand an acquired programme’s regulatory history from its filings, not from a summary someone wrote.
The history, read from the record
Per-sequence timeline
Each sequence with its submission type, date and what it carried: protocols, amendments, consent forms, brochures, meetings, responses, safety reports and study reports.
Protocol versions
Every version of every protocol, with the filed redline or summary of changes attached to the version it explains.
Clinical holds
Holds placed, continued and removed, in letter-date order, from the agency letters you filed.
Agency requests, word for word
Hold issues under their regulatory basis, information requests, and additional requests in meeting letters — in the agency’s own words, with the full text one click away.
Linked responses
Each request is linked to the filed response that restates it, with the document, heading, page and answer — marked Answered or Quoted.
Study pages
Every document filed for a study across all sequences, grouped by type, with its datasets and define files by the sequence they were filed in.
Accuracy rules
No AI, nothing summarised
Requests and responses are read from the filed documents, not paraphrased by a model. What you see is what was filed.
A link means a verbatim match
A response is tied to a request only when the agency’s wording appears in it word for word. Anything that does not match is left unlinked, not guessed.
Unanswered is not unresolved
A request no response quotes is shown as such. It is never presented as an open issue it may not be.
Every fact shows its source
Each item is marked as read directly from the filing, or classified by a stated rule from its title and location.
Frequently asked
Which agency letters does it read?
Clinical hold, hold-continued and hold-removal letters, information-request letters, meeting letters and information requests filed as email chains, as filed in your sequences.
Does it use AI to extract the requests?
No. Requests and responses are read from the documents by fixed rules, and a response is linked only on a verbatim match.
Do we need to tag or prepare anything?
No. The history is built from the filed sequences each time it is opened. Nothing is typed in.
Does it work on imported applications?
Yes. It reads any application loaded into DnXT Reviewer, whichever tool published it.
Your history is already filed. Read it.
Load an application you know well and see its development history, agency requests and responses assembled from the record.
