The clock starts at day zero. The source documents arrive in pieces.
Pharmacovigilance case processing services turn the source documents behind an individual case safety report into a chronological, source-faithful narrative, page-cited throughout. The safety physician assesses seriousness, expectedness and causality; the narrative they read is built and traceable to its sources.
The reporting standard is published. So is the clock.
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 pharmacovigilance, both are already published.
3 steps between the source and the submission.
Send the source documents
Reporter forms, hospital records, laboratory reports, discharge summaries and follow-up correspondence, in any format.
We return the narrative, page-cited
A chronological, source-faithful narrative with the drug and dose history, the event course, and the outcome, each statement citing the document it came from.
Your safety physician assesses
Seriousness, expectedness, causality and the reporting decision are the safety physician's. We never assess causality or submit a report.
A narrative from the sources, never a causality assessment.
We build the chronological narrative from the source documents and cite each statement to its source. We do not assess causality or relatedness, determine seriousness or expectedness, decide reportability, or submit to any regulator. Those are the safety physician's assessments and the sponsor's obligations.
Where source documents disagree on a fact, the narrative records the conflict and cites both rather than silently picking one. An inspector comparing narrative to source finds the discrepancy either way; better that the narrative found it first.
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 case narrative.
The case narrative is 1 deliverable of the same platform that reads, sorts, and cites the whole record.
Medical Records OCR
Every source document read in full — reporter forms, hospital records, laboratory reports, handwritten follow-up notes — nothing skipped, nothing guessed.
Medical Chronology
The case builds itself into a chronology, so drug exposure and event onset sit on one axis rather than in separate documents.
Verifiable AI Citations
If we can't cite it, we don't say it. Every statement in the narrative links to the source document behind it.
Medical Summary Reports
The narrative formats straight into the safety database — your template, your conventions.
ICSR case 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.