Enterprise DNA

Instead of Oracle Argus

Stop renting Oracle Argus. Own your drug safety system.

We build your version around your products, your markets and your procedures, bring your Argus cases across and run it for you. Start with the cases on the clock today.

Oracle does not publish a price for Argus. It licenses Argus by the number of cases you book in, not by user, as a quoted subscription or licence.

Get your version built See it working
  • check_circleYour data in a database you own
  • check_circleOpen source, no lock-in
  • check_circleBuilt and run by Enterprise DNA

The recurring bill

What your Argus agreement pays for

Oracle quotes Argus privately, by case volume. Here is what that agreement covers, set against owning the safety record yourself.

Globe

A database built for global pharma

Argus is sized for companies lodging cases in dozens of countries every day. A sponsor with a few dozen Australian and New Zealand cases a year pays for machinery it never turns on.

BarChart

A meter on every case

Oracle licenses Argus by case volume, not by user. A product launch, a recall or a busy month of literature cases moves the bill.

Building

A service provider in between

Many smaller sponsors rent Argus access through a vendor who hosts it and processes cases. You pay for their seat on the database as well as their people.

Settings

Validation and upgrades

Upgrading a validated safety database is a project: test scripts, validation documents and planned downtime. The work lands on your team or your vendor, on the vendor's timetable.

Database

Your cases inside someone else's system

Your safety history, the record an inspector asks for, sits in a licensed database. Leaving means an export project and an archive you keep paying to read.

Search

Reports someone else designed

The line listings and dashboards are the ones that were configured for you. A question nobody set up a report for waits for the vendor.

Your safety database

The weekly safety meeting, run from your own records

Cases

Every report booked in the day it arrives

A call, an email, a partner case, a journal article or a social media comment becomes a case with the date anyone in the business first heard of it.

  • check Day 0 starts the moment the reporter, patient, product and reaction are all known
  • check A case still missing one of the four asks for follow-up, not a guess
  • check Every reaction marked listed or not listed against your product information
  • check Duplicates are marked, never deleted

Deadlines

The TGA and Medsafe clock on every case

Seriousness and causality from your qualified person set the deadline that applies, and the clock shows it until the reference is recorded.

  • check 15 calendar days for a serious local medicine case, in both markets
  • check 2, 10 or 30 days for a device, by category of event
  • check 72 hours for a significant safety issue, 30 days for any other
  • check A medically relevant follow-up answer gets its own 15-day clock

Signals

Patterns the dashboard never charted

Ask in plain words whether something new is turning up, by ingredient, across both markets and overseas cases.

  • check Reaction terms counted for the last 90 days against the months before
  • check Terms your label does not list called out first
  • check A signal tracked from first look to the regulator notification
  • check Every deadline rule written down with its source

Records

Ready for an inspector

The records an inspection asks for come from the same place as the weekly work.

  • check An append-only record of who did what, and when
  • check Literature searches logged by market, with the search and the hits
  • check Partner reconciliations against each safety data exchange agreement
  • check Case reports and product safety summaries in your own branding

Make it yours

Design your own Oracle Argus replacement

Everything starts from the open-source base. Then it gets your name, the parts you run, your rules and your data from Oracle Argus. Try it here, and we build the real one.

2. What it runs

3. Make it fit

4. Your colour

Your business · your Oracle Argus replacement Your version
YB Your business

auto_awesome

Answered from your own database

Build my version

We build it from the open-source base, bring your Oracle Argus data across and run it for you.

What it looks like

Ask it like you would ask a colleague

Real answers from the demo data that ships with Drug Safety for Claude Code. It runs in Claude Code inside the Claude app, so it feels like any chat you already use.

forum

Drug Safety for Claude Code

Connected to your own database

Which cases are due to the TGA or Medsafe, and which are already late?

C-0003

Product
CVX-NZ
Regulator
Medsafe
Rule
serious
Day_zero
2026-10-17
Rule_days
15
Due_on
2026-11-01
Days_left
-3
Causality
possible

C-0006

Product
FLX-AU
Regulator
TGA
Rule
death serious injury
Day_zero
2026-10-23
Rule_days
10
Due_on
2026-11-02
Days_left
-2
Causality
possible

C-0002

Product
CVX-AU
Regulator
TGA
Rule
serious
Day_zero
2026-10-22
Rule_days
15
Due_on
2026-11-06
Days_left
2
Causality
possible

C-0010

Product
CVX-AU
Regulator
TGA
Rule
serious
Day_zero
2026-11-01
Rule_days
15
Due_on
2026-11-16
Days_left
12
Causality
-

C-0007

Product
FLX-AU
Regulator
TGA
Rule
near event
Day_zero
2026-10-25
Rule_days
30
Due_on
2026-11-24
Days_left
20
Causality
unlikely

Ask it anything

Ten questions your safety records answer

These run against the working demonstration today. Your own version asks them of your products, your markets and your case history.

chat_bubble Which serious cases are due to the TGA or Medsafe this week, and which are already late?
chat_bubble Which reactions keep turning up that our product information does not list?
chat_bubble How many days, on average, do we take from Day 0 to lodging a report, by market?
chat_bubble Which follow-up answers changed a case and have not gone back to the regulator?
chat_bubble Which cases are still not valid, and what is each one missing?
chat_bubble Which serious cases has nobody assessed for causality?
chat_bubble When did we last run the literature search for each market, and did it find anything?
chat_bubble Which partners have not reconciled their safety cases with us on schedule?
chat_bubble Which cases came from overseas, and how many involve a reaction our label does not list?
chat_bubble What goes into the next periodic report for Corvexa, and when is it due?

Switching

How to switch from Oracle Argus

In practice, the move is a case-listing export, a tested import, a review of flagged rows, and a short period of running both systems side by side.

  1. 1

    Export the case listing

    Export a case line listing from Oracle Argus as a CSV. Check that the listing includes the cases and details you need before you move on. The import brings across cases, reactions, seriousness, causality, and reports already lodged. Keep your original Argus records available, since MedDRA coding, electronic messages, and the Argus audit trail remain in your Argus archive.

  2. 2

    Test, then load cases

    Start with the import test run. It shows every row it cannot read, so review the results before loading the cases. Once you are ready, run the import to bring the records across. Cases already lodged stay lodged, while reportable cases that have not been lodged land on the reporting clock. Do not treat the test run as a replacement for checking the imported records.

  3. 3

    Review flagged rows

    Check every row the test run could not read, and confirm that the imported case details match the Argus listing. Pay particular attention to reactions, seriousness, causality, and whether a report was already lodged. Resolve any gaps before relying on the new database for active cases. Keep coding, electronic messages, and the Argus audit trail in the Argus archive for inspection.

  4. 4

    Run both side by side

    For a short period, keep Oracle Argus available while you check the new database against it. Compare active case details, seriousness, causality, lodged status, and the reporting deadlines shown for cases that are still reportable. Make clear to staff which system is authoritative for each action during this period, and reconcile any differences before you stop using Argus for new work.

  5. 5

    Switch off Argus use

    Once you have checked the imported records and completed the side-by-side period, stop entering new work in Oracle Argus and use the new database for your safety case work. Keep the Argus archive available for the records that remain there, including coding, electronic messages, and the audit trail. Retain it for inspection rather than treating the migration as a transfer of every Argus record.

construction

Where the real effort goes

The import is only part of the work. Most of the effort is mapping your own fields and working rules, then deciding how much history to bring across. The case import covers cases, reactions, seriousness, causality, and reports already lodged, while coding, electronic messages, and the Argus audit trail stay in your archive. Enterprise DNA handles the migration and setup work when you have them install and run it.

Not ready for a call?

Get your Oracle Argus switch plan by email

We will send you the step-by-step plan for moving your business off Oracle Argus, what the move really involves, and how we would do it for you.

One email with your plan. No spam, and you can unsubscribe any time.

Three ways to own it

Choose how much you want us to handle

Open source

Do it yourself

Free, open source

  1. 1 Clone the repo and run npm install, npm test and npm run demo
  2. 2 Open it in Claude Code, Codex, OpenCode or Cursor and ask what needs attention
  3. 3 Add your products and labels, then test your Argus line listing with a dry run
  4. 4 Put your logo on the case reports and product summaries in brand.json
Get it on GitHub

Built around your business

We customise it

One setup fee, then a retainer for ongoing work

  • check Your products, markets, reporting procedures and partner agreements
  • check Your Argus history, or another safety system's export, mapped and checked
  • check A web front end or an intake form for your call centre if your team wants one
  • check Your MedDRA coding and medical review steps built in
Get your version built

Omni by Enterprise DNA

We run it for you

One setup fee, then a retainer

  • check Installed with access, backups and ownership agreed
  • check The weekly safety review prepared for your qualified person
  • check Deadlines, follow-ups and partner reconciliations chased the same day
  • check Run through Omni by Enterprise DNA beside the rest of your business
Book a safety review

Questions

Instead of Oracle Argus, answered

What does Oracle Argus cost compared with this? expand_more

Oracle does not publish a price for Argus; it is quoted by case volume, often through a service provider, so bring your agreement. The free version has no licence fee; hosting and your agent subscription are separate. Enterprise DNA builds and runs your version for one setup fee, then a retainer.

Can it lodge reports with the TGA or Medsafe for us? expand_more

It drafts each report from the case and holds the deadline. A person lodges it through the regulator's online form or email, the way most Australian and New Zealand sponsors already do, and records the reference. If you lodge enough cases to want a direct electronic link, that is part of what Enterprise DNA builds into your version.

Who decides whether a case is serious or related? expand_more

Your qualified person, as now. The system records their assessment, shows the deadline that follows and keeps the history. It never decides seriousness, causality or whether a signal is real.

Can we bring our Argus cases across? expand_more

Yes. Export a case line listing to a spreadsheet file and the free version brings across cases, reactions, seriousness, causality and any report already lodged, with a test run first. Coding, electronic messages and the Argus audit trail stay in your Argus archive for inspection.

Is a database we own good enough for an inspection? expand_more

Inspectors ask whether cases were lodged on time, whether follow-up was chased, whether literature was searched and whether partners were reconciled. Every one of those is a record here, with an append-only log of who did what. Validating your version against your own procedures is part of the setup Enterprise DNA does.

Bring your case list and your Argus agreement

Spend 30 minutes with Sam. We will look at how your cases are booked in and lodged today, what is on the clock, and what your own version should do first.

Book a 30-minute call with Sam Get the free version

Drug Safety for Claude Code is free and open source, published by Enterprise DNA.

Done paying for Oracle Argus?

Get your version built