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07 — Drug safety

Pharmacovigilance

Every adverse event captured, assessed and reported on time.

One system for drug-safety cases: intake from the website, phone and field teams, assessment with a full audit trail, and regulatory deadlines tracked from the day a report arrives.

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Type
Drug-safety case management
Users
PV officers, medical team, field staff
Intake
Web form, email, phone, field
Audit
Full audit trail

01 — In use

Pharmacovigilance

Interface shown with sample data.

02 — What it does

  1. 01

    Multi-channel intake

    Reports from the public website form, email, the call centre and medical reps in one queue.

  2. 02

    Case processing

    Triage, MedDRA coding, seriousness and causality assessment, follow-ups and closure.

  3. 03

    Regulatory clocks

    Reporting deadlines calculated from receipt and tracked to submission.

  4. 04

    Signals and literature

    Safety signals tracked and published literature screened for your products.

  5. 05

    Roles and audit trail

    Every change recorded, with role-based access for safety and medical staff.

  6. 06

    Reports

    Case listings and periodic summaries for management and the authority.

03 — Who it's for

Pharmaceutical manufacturers and distributors with a legal duty to collect, assess and report adverse events — on a clock.

Runs on its own — and connects with

How we deliver

From your process to production.

  1. 01MapYour process, roles and approvals written down before anything is configured.
  2. 02ConfigureWe set the product up on your structure, rules and data, in Arabic and English.
  3. 03TrainYour staff are trained on the work they actually do.
  4. 04RunMonitoring, support and the next module, by the team that built it.

Want to see it
on your own data?

Tell us how your team works today. We reply within two business days with questions, then give you a walkthrough based on your process.

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