400 narratives, 1 house style, and a submission date.
CSR patient narrative services draft the individual narratives a clinical study report requires for deaths, serious adverse events and discontinuations. Each is built to the ICH E3 structure in your house style, page-cited to the source data, and delivered for your medical writer's review and sign-off.
The reporting standard is published. So is the reviewer.
We do not build for a case type until we can name the standard that defines a correct output and the person who grades the file against it. In clinical study reporting, both are already published.
3 steps between the data and the report.
Send the source data and the template
Subject listings, source documents, the narrative template and your style conventions, in any format.
We return the drafts, page-cited
Each narrative in your template and house style, with the event chronology, exposure and outcome built from the source and cited to it, and discrepancies flagged.
Your medical writer reviews and signs off
The narrative is the sponsor's document. Medical assessment, causality language and sign-off stay with your medical writer and safety physician.
A drafted narrative, never a medical assessment.
We draft the narratives to your template from the source data and cite each statement to it. We do not assess causality, author a medical judgment, decide seriousness, or sign off a narrative. The narrative is the sponsor's document, reviewed and approved by the sponsor's medical writer and safety physician.
Where a subject listing and the source document disagree, the draft flags it rather than silently following one. A reviewer comparing narrative to source finds the discrepancy anyway, and a flag at draft stage is the cheapest place to resolve it.
The rules the platform never breaks.
EVERY LINE CITED
HIPAA, under a signed BAA
Every file is handled under our Business Associate Agreement, from the first byte.
Never trains a model
Your records are never used to train any AI model — ours or anyone else's.
Every line cited
If we can't cite it, we don't say it. Every sentence links to its source page.
Deleted after delivery
Files are deleted 30 days after delivery, with a full audit log of every access.
4 capabilities behind every narrative draft.
The narrative draft is 1 deliverable of the same platform that reads, sorts, and cites the whole record.
Medical Records OCR
Every source document read in full — subject listings, hospital records, laboratory reports, handwritten site notes — nothing skipped, nothing guessed.
Medical Chronology
Each subject's course builds itself into a chronology, so exposure, event onset and outcome sit on one axis.
Verifiable AI Citations
If we can't cite it, we don't say it. Every statement in the draft links to the source it was built from.
Medical Summary Reports
The drafts format straight into the CSR — your template, your house style.
CSR patient narratives, answered.
Send 1 file. We'll tell you what we can read.
No obligation. If the case type is buildable we'll scope it; if it isn't, we'll say so.