Learn regulatory AI by building the document, not by watching a demo.
In a single afternoon you draft a real clinical study report with Claude, working from a synthetic dataset, with the FDA and EMA compliance guardrails built into every step.
Most AI courses tell you what is possible. Amia University workshops put you to work. You leave with a finished CSR section and a process you can run on your own submissions the next morning.
A total of 142 subjects in the safety set reported at least one treatment-emergent adverse event over the 24-week period.
The most frequent event was mild headache, recorded in 18.3% of the active arm [AM-204 safety set]
No serious adverse events were considered related to study treatment by the investigator.
What you walk out with
A finished deliverable, and a process you can repeat.
A completed CSR section
Drafted end to end in the room, from the synthetic dataset to formatted, submission-ready output.
A workflow you can reuse
The prompts and the review loop, documented, so you can run the same method on your own study data.
A clear view of the guardrails
You see exactly where compliance checks sit, and where a human has to stay in the loop and sign off.
Confidence to do it for real
You leave ready to apply the process to a live submission, without guessing at what is safe to automate.
The workshop
Four steps, one finished section.
The whole afternoon is built around a single idea: you do not learn regulatory AI by watching it, you learn it by producing a real document with it.
90-second demo
Watch Claude turn raw data into a cited draft.
This is the moment the workshop is built around. We hand Claude a synthetic clinical dataset and watch it produce a first draft of a report section, with every claim traced back to a source.
Nothing proprietary is ever used. The dataset is synthetic by design, so you can learn the method without touching sensitive study data.
142 subjects reported at least one treatment-emergent adverse event.
The most frequent event was mild headache, in 18.3% of the active arm.
[AM-204 safety set]No serious events were considered related to study treatment.
What that looks like
Synthetic data in. A sourced paragraph out.
| Subject | Event | Sev. | Outcome |
|---|---|---|---|
| AM-0142 | Headache | Mild | Resolved |
| AM-0143 | Nausea | Mild | Resolved |
| AM-0151 | Fatigue | Mod. | Resolved |
| AM-0166 | Dizziness | Mild | Ongoing |
The most frequently reported treatment-emergent adverse events were headache and nausea, both mild in severity and resolved without intervention. [adverse_events.csv]
The afternoon, step by step
From the rules to the hand-off.
The guardrails, before the tools
We start with the rules: what has to stay with a human, where claims must be sourced, and how the compliance checks work. You set these up before you draft a word.
From synthetic dataset to a first draft
You load the dataset and produce a first CSR section draft with Claude, watching each claim get traced back to its source as it is written.
Review, correct, and cite
You run the review loop: catching unsupported statements, fixing figures, and confirming every citation holds up to scrutiny.
Format and hand off
You bring the section to submission standard and package the workflow so you can repeat it on your own study data.
Will this work for me?
Built for lean regulatory teams.
You don't need to be. If you can write a clinical document, you can run this workflow. There is no code.
That's who it's for. The method is designed for one-person regulatory functions and lean biotechs that need leverage.
You work entirely from a synthetic dataset. Nothing proprietary is used, so you can learn safely before applying it at home.
The approach is the same whether you write for the FDA or the EMA. The document changes; the method holds.
Free, no sign-up required
Watch one full mini-lesson before you decide.
A real excerpt from the workshop, not a trailer. Follow along as we take a single finding from the synthetic dataset and turn it into a cited paragraph of the report.
- ✓See the exact prompt that starts the draft
- ✓Watch a guardrail catch and flag an unsupported claim
- ✓Decide for yourself whether the method fits your work
Headache and nausea were the most common events, both mild and fully resolved.
Also inside the lesson
A short tour of the interface you'll be working in.
The safety and efficacy populations were comparable across treatment arms with respect to age, sex, and baseline disease severity.
Mean age at enrolment was 54.2 years, with 61% of subjects identifying as female [demographics.csv]
No clinically meaningful imbalances were identified between the active and control groups.
Your instructor
Chloe runs the room, start to finish.
Chloe designed the CSR drafting method you will use, and she stays on camera with you through the whole afternoon. When a prompt stalls or a guardrail fires, she shows you why and what to do next.
This is a working session, not a lecture. You share your screen, you draft, and she reviews alongside you in real time.
A 60-second hello
Meet Chloe before the workshop.
Reserve your seat
Painless to sign up. Painless to expense.
No payment is taken on this page. Tell us you're in, and we send the details, the invoice, and everything your finance team needs.
- ✓Itemized receipt, every timeA clean, itemized receipt so you can expense without a back-and-forth.
- ✓Purchase orders for teamsBuying several seats? Request a PO and we handle the paperwork once.
- ✓California buyersYour purchase may qualify through the California Employment Training Panel (ETP). Ask us and we'll help you check.
- ✓Key datesRegistration opens November 6. We confirm the cohort on December 15. Last day to sign up is December 31.
Questions