Safety work demands accuracy, oversight, and traceability, not disconnected tools or external AI copilots.

CARA AI operates natively inside the CARA platform, supporting pharmacovigilance and safety documentation workflows while preserving human review, medical judgment, and controlled processes.

Safety operations with clarity, continuity, and control

Review safety documentation faster, without cutting corners

Reduce the manual effort required to assess aggregate reports, signal evaluations, and authority feedback.

Maintain alignment across safety documents and plans

Identify where labels, RMPs, and reports diverge as content evolves across versions and regions.

Improve oversight across the safety portfolio

Surface what changed, what’s missing, and what requires attention across ongoing safety activities.

Prepare confidently for inspections and audits

Demonstrate control, traceability, and consistency across safety documentation when regulators ask.

What CARA AI does inside Safety workflows

From manual processes to AI-powered efficiency

Compare safety reports and plans

Compare current and prior PBRERs, PSURs, labels, and RMPs to identify semantic differences and misalignment.

Align labels and RMPs

Cross-check safety information to ensure risks, mitigations, and wording remain consistent across documents.

Summarise aggregate safety content

Summarise PBRERs, DSURs, signal assessments, and Health Authority feedback into concise review-ready narratives.

Generate controlled draft content

Draft boilerplate sections for aggregate reports and first drafts for RMPs, safety variations, and inspection packs.

Localise safety documentation

Adapt safety communications and RMPs for regional use while enforcing controlled terminology (e.g., MedDRA, ICH, EMA).

Before

After

Assisted intelligence, inside existing Safety workflows

No exports. No parallel systems. No disruption to established governance.

Safety documents remain controlled within the platform
AI analyses content using structure, context, and intent
Related documents, risks, and records are linked automatically
Drafts, summaries, and comparisons are produced within existing review and approval workflows

Built-in, not bolt-on

Your content stays inside CARA.

Permissions and audit trail apply automatically.

Completely Compliant

No external AI tools needed.

Trust & Proof

Users

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Enterprise Clients

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SLA

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Expert Support

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Largest Life Science companies

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“CARA will reduce manual effort, shorten submission cycles…”

“Moving from a system with no versioning … was a real breath of fresh air.”

What Makes Us Different?

See CARA AI automate classification, extraction, summarization and generation across R&D, Regulatory, Safety and Quality