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Thallyx
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AI case processing for pharmacovigilance

Every case coded, narrated and submission-ready, inside the clock

Thallyx takes an adverse-event report in whatever shape it arrives, works it into a regulator-ready case, and escalates only the ones that genuinely need a safety physician.

Let’s talkSee how it works

It arrives looking like this

0 days

to submit a serious case. Seven if it is a fatal or life-threatening SUSAR.

Regulatory requirement

0k+

individual case safety reports a year at a single large marketing authorisation holder.

Industry estimate

$0–200

per case to process by hand. The reason this work went offshore in the first place.

Industry estimate

Timelines are regulatory requirements. Volume and cost ranges are widely cited industry estimates included to describe the problem — they are not Thallyx’s measured results.

The structural gap

The system of record was never the hard part

Argus and ArisGlobal are filing cabinets with workflow attached. They hold the case; they do not read the voicemail, decide whether it is even a valid case, choose the coded term, or write the narrative. That work is done by people — thousands of them, offshore, against a clock, at a cost that scales linearly with volume.

The contracts that pay for those people are worth billions a year and are pure labour arbitrage. That is the line item Thallyx replaces — not the software licence next to it.

Where every case begins

Four things have to be true before it is a case at all

Miss one and it is not reportable. Wrongly decide one is missing and you have lost a case you were legally obliged to submit. This judgement gets made hundreds of thousands of times a year, mostly by someone on their fourth hour of a queue.

01

An identifiable patient

Not a name — an initial, an age band, a sex, anything that distinguishes one person from another. Reports arrive without it constantly, and the follow-up request has to go out the same day.

02

An identifiable reporter

A consumer, a nurse, a physician, an author. Reporter type changes how the case is weighted and, in some jurisdictions, whether the clock starts at all.

03

A suspect product

Named, mis-spelled, described by indication, or given as a local brand nobody in the intake queue recognises. Matching it to the right product and dose form is where a surprising number of cases stall.

04

An adverse event

Reported in the language the patient used, not the language MedDRA uses. "Felt like my heart was going to jump out" is a real report and has to become a real coded term.

How it works

From a voicemail nobody wants to open to a case ready to submit

Four stages, run on every report, with the source document carried through all of them.

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.

How the agent is constrained

An agent in a GxP process has to be able to show its work

Four constraints decide whether your quality team can accept this at all. They are commitments in the agreement, not aspirations on a website.

01

Every field traces to a source span

A coded term, a seriousness call, a narrative sentence — each one links to the exact text in the source document that produced it. In a GxP setting an output nobody can trace is an output nobody can use, and an inspector will ask.

02

Ambiguity escalates, it does not resolve itself

The product's value is that only genuinely ambiguous cases reach a safety physician. That only holds if the agent is honest about which ones those are. Confidence is a routing decision, never a substitute for one.

03

The agent never decides seriousness alone on a fatal case

Death, life-threatening events and anything on your configured escalation list route to a human every time, regardless of how clear the agent finds them. Some decisions should not be automated even when they can be.

04

Nothing is asserted that the source does not support

Narrative drafting is where a language model is most tempted to smooth a gap into a plausible sentence. Thallyx leaves the gap visible and flags it, because a tidy narrative built on an inference is a regulatory finding waiting to happen.

Read the full compliance posture
Who it's for

Two buyers, opposite sides of the same contract

Pharma safety teams

Your headcount stops scaling with your volume.

Case volume grows with every product, every market and every new intake channel. Headcount cannot grow with it, and the quality cost of a stretched team lands on the QPPV. Thallyx absorbs the routine volume so your physicians spend their time on the cases that need a physician.

Per-case pricing, against a $50–200 human cost

Output lands in your existing safety database

Escalation rules configured to your SOPs, not ours

Pharma safety teams
CROs and BPOs

Your margin is a headcount arbitrage that is closing.

Case processing contracts are priced on offshore labour. When a client can buy the same throughput per case, the arbitrage disappears — and the vendor who moves first serves the same book with a fraction of the staff, at a better margin, instead of losing it.

Serve existing contracts at a materially lower unit cost

White-label under your own quality system

Your QC layer stays yours — we replace the keystrokes

CROs and BPOs
Start with your worst queue

Send us a month of cases you are behind on

We would rather be measured against a real backlog than a demo. Tell us the volume, the channels and the safety database you run.