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What it does

A report arrives. A case leaves.

Thallyx is the processing layer between your intake channels and your safety database. It does the reading, the coding, the assessment and the drafting — and hands a physician only the cases that actually need one.

A synthetic voicemail worked into a case. Each stage resolves against a specific span of the source document, and anything the record cannot settle is flagged rather than assumed.

The pipeline

Four stages, run on every report

The source document is carried through all of them, so a reviewer can always get back to the sentence that produced a field.

01 · Intake

Intake, in whatever shape it arrives

A voicemail from a call centre. A scanned fax with handwriting in the margin. A PDF of a Japanese case report. A patient support programme export. An email chain with the event buried in the third reply. Thallyx reads all of it, transcribes and translates where it has to, and normalises it into one intake record.

Source documents are retained and linked, so every downstream decision can be traced back to the sentence that produced it.

Intake queue — live

Ingesting
audioVoicemail · MI line
Transcribed
imageScanned CIOMS form
OCR complete
pdfLiterature · JP
Translated
csvPSP export
Parsed

Normalised record

One intake schema. Source document retained and linked to every field it produced.

02 · Validity

Validity, and what to chase

The four criteria are extracted and checked. Where one is missing, Thallyx drafts the follow-up request naming exactly what is absent — rather than sending the generic template that comes back empty and burns another week of the clock.

Duplicate detection runs at this point, against the existing safety database rather than against the current batch alone.

Validity — four criteria

Identifiable patientFemale, 71
Identifiable reporterDaughter — consumer
Suspect productVeltarib (fictional)
Adverse event3 verbatim terms

Follow-up drafted

Batch number and concomitant medications not provided. Request names both, rather than sending the generic template.

03 · Coding

Coding and assessment

Events are coded to MedDRA at the appropriate level, with the verbatim term kept alongside the selected LLT and its PT. Seriousness is assessed against the defined criteria, expectedness against the reference safety information for that product, and causality per the convention your organisation uses.

Every selection carries the reasoning and the source span. A coder reviewing the case sees why, not just what.

MedDRA — verbatim to preferred term

“rash all over her arms and chest”

PT Rash generalised

“her face swelled up”

PT Face oedema

“couldn't breathe properly”

PT Dyspnoea

Seriousness

Hospitalisation

Expectedness

Unexpected

04 · Narrative

Narrative and submission

The case narrative is drafted in your house style, in chronological order, covering the patient, the history, the event, the treatment and the outcome — with nothing asserted that the source documents do not support. The case is assembled to E2B(R3) for onward submission.

Output lands in your existing safety database. Thallyx is the processing layer, not a replacement system of record.

Case narrative — draft

218 words

A 71-year-old female patient began treatment with Veltarib approximately three weeks prior to onset. On an unspecified date the patient developed generalised rash, followed the next day by face oedema and dyspnoea, resulting in overnight hospitalisation…

Every highlighted clause links to the source span that supports it.

Gap left visible

Onset date not stated by the reporter. Recorded as unspecified rather than inferred from the call date.

Escalation

The whole product rests on getting this right

Automating the routine is easy to sell and easy to build. Being honest about which cases are not routine is the part that decides whether a safety physician ever trusts the queue again.

Always, regardless of confidence

  • Death, or a life-threatening outcome
  • Anything meeting your configured 7-day SUSAR definition
  • Paediatric and pregnancy cases, where your SOPs require it
  • Products under additional monitoring or a risk management plan commitment

When the record genuinely will not settle it

  • Causality where the temporal sequence is contradictory
  • Expectedness where the RSI language is ambiguous for this presentation
  • A verbatim term with no defensible MedDRA equivalent
  • Conflicting accounts between reporter and source document

Never

  • Because throughput targets are behind
  • Because a queue is ageing toward its clock
  • Because a confidence score sits just over a threshold
  • Because the case is tedious rather than ambiguous

We are not replacing your safety database

Argus, ArisGlobal, LifeSphere, whatever you run — it stays. It is your validated system of record, your inspection history lives in it, and replacing it is a multi-year programme nobody wants.

Thallyx sits in front of it. Cases arrive in your database already coded, assessed, narrated and ready for your QC step — which is exactly what the offshore team was producing, at a fraction of the unit cost and without the queue ageing while someone is asleep.

Named integrations are agreed per engagement. Thallyx claims no vendor partnership or certification it has not signed.

See it on your own cases

Bring a month of your worst queue

A real backlog, with the messy intake channels and the cases that have been sitting at day eleven.