Industry
Risk management for healthcare and pharma
Healthcare and pharmaceutical organisations operate in one of the most heavily regulated environments in the world. Patient safety, clinical trial integrity, regulatory approval pathways, and data governance all demand rigorous, auditable risk management. Norrsent provides a platform built for that level of scrutiny.
The challenge
Patient safety, regulatory scrutiny, and data governance leave no room for reactive risk management
Risk is fragmented across clinical, operational, and regulatory domains
Clinical trial risk, patient safety, pharmacovigilance, and regulatory compliance are managed in separate systems. There is no unified view of organisational exposure or a single source of truth for risk leadership.
Regulatory inspections require evidence that takes weeks to compile
When the FDA, EMA, or MHRA request evidence, teams spend weeks pulling together documents from disparate systems — under inspection pressure, with limited time to address gaps before the assessment.
Incident reporting doesn't feed back into risk registers
Adverse events and near-misses are captured but rarely trigger systematic updates to risk registers or mitigation plans. Root causes go unaddressed across the organisation, increasing the likelihood of recurrence.
How Norrsent helps
Patient safety and clinical risk
Maintain structured risk registers for patient safety, clinical trials, and care delivery. Risk scoring is aligned to your organisation's risk appetite and regulatory requirements.
Regulatory compliance (FDA, EMA, MHRA)
Map regulatory requirements to controls and processes. Generate evidence packages and compliance summaries ready for regulatory submission or inspection.
Pharmacovigilance and incident reporting
Capture adverse events and safety signals with structured forms and automated workflows. Full immutable audit trail for regulatory reporting obligations.
Audit-ready documentation
Every risk assessment, control test, and mitigation action is stored with a complete, tamper-proof history — so your team is inspection-ready at any point.
Common use cases
How organisations in this sector use Norrsent
Clinical and Patient Safety Risk
Structured risk registers for clinical trials and patient care with ISO 31000-aligned scoring, configurable risk appetite, and role-based visibility for clinical, compliance, and executive teams.
Regulatory Compliance (FDA, EMA, MHRA)
Map regulatory requirements to controls and processes. Generate structured evidence packages ready for submission or inspection — without weeks of manual document gathering.
Pharmacovigilance Incident Reporting
Capture adverse events and safety signals with structured forms, severity classification, and automated workflows. Every submission is backed by an immutable audit trail.
Audit-Ready Documentation
Every assessment, control test, and mitigation action is stored with a complete, tamper-proof history. Your team is inspection-ready at any moment — not just the weeks before an audit.
Get started
Talk to us about healthcare and pharma risk