Connected Pharmacovigilance

CARA is not a standalone PV tool. Case management, risk plans, PSMF, and safety submissions live on the same platform.Predict, analyse, and react faster with a seamless platform for safety data.

Trusted by leading regulatory teams across life sciences

Bayer

UCB

PSUR efficiency improvement

0 %

PSMF compilation improvement

0 %

Medical Inquiries efficiency gain

0 %

Of top 20 pharma run on CARA

0 %

Explore Safety

Everything your Safety function needs. On one platform.

One Safety deployment. Connected capabilities not separate systems to license and stitch together.

Risk Management & Compliance

Risk Management & Signal Detection
PV System Master File (PSMF)
Safety Submissions & Distributions

End-to-End Safety Case Management

PV Case Management
Medical Inquiries & MedDRA Integration
Safety Data Exchange Agreements (SDEAs)

Built for regulated environments.

Designed to meet GxP · 21 CFR Part 11 · GDPR

Audit trails that already exist

Every action, every output, every change, captured automatically.

Data integrity by design

One data model across case management, risk plans, and submissions means no conflicting versions, no manual reconciliation.

Inspection readiness as default

Controlled lifecycles, version management, and access controls are built into every safety workflow.

Customer story

MERCK KGAA

Users benefit from faster process times, better performance in CARA than previous systems, and a single UI that is consistent across repositories, allowing for reduced training. IT has an easier task with system maintenance and a single common infrastructure for their systems.

Read the full case study

85,000 users
12 consolidated systems
18 million documents
21 CFR Part 11
PSMF compilation: three weeks to minutes.

AI underneath it all

Safety operations that are faster because they're safer.

CARA AI drafts PSURs, PBRERs, and DSURs, generates the PSMF directly from live governed data, and checks label/RMP/CCDS alignment before submission, inside your governance framework, not around it.

50–70%

Reduction in PSMF & PSUR/PBRER/
DSUR drafting time per cycle

Common Questions

Before you explore further

Is this one product or several tools stitched together?

One governed record. Case management, risk plans, the PSMF, and safety submissions all share the same data model — so a case’s MedDRA coding, the RMP it’s linked to, and the PSUR it feeds into are the same record viewed differently, not separate exports reconciled by hand.

What happens to our existing safety system?

Both migration and coexistence are valid. Some customers move case management, PSMF, and submissions fully onto CARA. Others keep an existing safety system in place and use CARA as the unified layer connecting it to Regulatory and Quality data.

Does connecting Safety to Regulatory and Quality mean giving up dedicated PV depth?

No — each function is a complete, dedicated capability. Case management covers structured and unstructured intake through E2B R3 output; the PSMF is compartmentalised and auto-compiled; submissions track to acknowledgement in every market. They share one data model because that’s what removes the reconciliation work between them, not because any one is a shortened version of a bigger tool.

Platform Connectivity

Safety data that doesn't stop at Safety.

When your safety records live on the same platform as Regulatory and Quality, everything accelerates. PSUR drafting draws from live regulatory data. Labelling changes flow into Quality workflows automatically. One source of truth for product data, labelling, and safety signals — no reconciliation.