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Safety work is messier than your SOPs. We create a map of what’s in your team’s heads.

Start mapping now See what you get
Case intake to submissionSample
Steps9The SOP says 7
Hand-offs4Across 2 sites
Unwritten rules4Written nowhere
Critical steps4Inspectors check these
Steps
7
Hand-offs
–
Unwritten rules
–
Minutes per case
–
  • Inspection-critical
  • Not in the SOP
  • Hand-off
What this process costs
Copenhagen30 min × €90/h€45
+
Bangalore46 min × €25/h€19
=
Per case76 min€64
× =
A year €385,000
The problem

Most of how your safety work runs isn’t written down anywhere.

The know-how sits with a few people.When they leave, changes and system migrations stall.
SOPs grow after every audit.Nobody can say which lines the law requires and which are habit.
Work breaks where it changes hands.A label update is due in 2 months, and translations take 4–5 weeks of that. One late hand-off and the deadline slips.
How it works

Your whole team is interviewed at once, in 30-minute calls.

The AI interviewer books each call on Teams, Google Meet or Zoom, when it suits each person. Nobody has to sit down with a consultant.

Interviews this week 0 in a call now
  1. CPCase processorBangalore · ENMon 09:00In callDone
  2. CPCase processorBangalore · ENMon 11:30In callDone
  3. INIntakeCopenhagen · DAMon 13:00In callDone
  4. MRMedical reviewerCopenhagen · DATue 08:30In callDone
  5. CPCase processorBangalore · ENTue 10:00In callDone
  6. QCQC leadBangalore · ENTue 14:00In callDone
  7. LSLiterature screenerCopenhagen · DAWed 09:00In callDone
  8. DQDeputy QPPVCopenhagen · DAWed 15:30In callDone
0 of 12 done
One interviewerOne call after another Weeks
NoeaAll calls at once Days
Timeline

One process area, mapped in 4 weeks.

Week 1Week 2Week 3Week 4
Kickoff1 hour with the process owner
Interviews8–15 people, all in parallel
Draft map
Validation workshopsWith your process owners
Handover
The mapSteps found, then checked
Your team's time
Process owner
about 4 h
Each operator
30 min
Total
about 10 h

With 12 operators. That covers the kickoff, the interviews and two workshops. Everything else is on us.

What you get

At the end of week 4 you get a map, a gap list and a roadmap. All of it is yours.

The process as your team really runs it.

Every step, who does it, how long it takes, and where it changes hands. Your process owners check it before it's final. Export it any time.

Set day 0Not in SOP
Who
Intake, Copenhagen
Time
3 min per case
Type
JudgementInspection-critical
Rule
Partner cases: day 0 is the partner's receipt date
Next
Hand-off to Bangalore
Checked
Process owner, workshop 2
ExportExcelBPMNPDF

Every place where your SOPs, your practice and GVP disagree.

Each gap links to its step and to what people said in the interviews.

SOP-PV-012 against practice4 gaps
  • ≠QC on every casePractice: serious cases onlyDiffers
  • +Duplicate check in a spreadsheetDone daily, not in the SOPMissing
  • !Day 0 for partner casesDone right, written nowhere. GVP Module VIWrite down
  • +Due dates tracked in ExcelOutside the validated systemRisk
  • ✓Medical review of serious casesSOP and practice matchOK

Each step marked as rule-based, judgement or inspection-critical.

So you can see where the hours go, and where an inspector expects a person.

One case, start to finish76 min
  • Data entry22 min
  • Medical review12 min
  • Assessment11 min
  • Duplicate check8 min
  • MedDRA coding7 min
  • 4 more steps16 min
Rule-based
50 min
Judgement
26 min
Inspection-critical
4 steps

A ranked list of what to fix first.

Ranked by inspection risk and time saved, including which steps could be automated later.

1Start now
Data entry22 min · low risk
Duplicate check8 min · low risk
MedDRA coding7 min · low risk
2Next
Validity check5 min · medium
Deadline trackingout of Excel
·Keep with people
Assessmentjudgement
Medical reviewjudgement
Set day 0write the rule down
Data and access

We talk to your people. We never touch your systems or case data.

  • No case or patient data. We ask how the work is done, not about cases.
  • No system access. We never log in to your systems or connect to them.
  • Hosted in the EU. We sign an NDA before kickoff.
  • You own all of it. Export the map at any time.
Price

One process area in 4 weeks, for a fixed fee.

PilotFixed scope
Process area
1, you choose
Interviews
8–15 people
Workshops
2, with your process owners
Time
4 weeks
You get
Map, gap list, roadmap
Price
Fixed fee

We agree the fee on the scoping call, before any work starts.

Add later if you want
  • More process areas
  • SOP clean-up
  • Vendor oversight model
  • Inspection-readiness review
  • Automate one step
Simon Ammann
CEO · hello@noea.ai

Start mapping now

We start with a 20-minute call to pick the process and the people.

Which process would you map first?

Used only to reply to you. Privacy

Questions

Before you ask.

Does Quality need to approve this?

The interviewer is a structured interview tool, not a GxP system. It never sees case data. Your process owners check and sign off the map before it's final. We're happy to walk Quality through it on a call.

Will our operators have time?

Each interview takes 30 minutes, at a time that suits them, in their own language. A short note from their manager before we start helps.

Who checks the map?

Every step is compared across interviews, then checked by your process owners in two workshops. Experienced pharmacovigilance people review the map before handover.

What happens after the 4 weeks?

The map is yours to keep. We can keep it up to date, map more process areas, or help you automate the first step on the roadmap. If you'd rather hand the work over, that's what Noea does.