© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved
CARA AI runs where your content lives.
It inherits the security, governance, and compliance of the CARA Platform, across Regulatory, Safety, Clinical, and Quality.
One governed AI layer across Safety, Clinical, Regulatory, and Quality
Regulatory
See how regulatory teams use CARA to manage submission content, automate document assembly, and stay inspection-ready across every market.
Safety
Watch how safety teams process ICSRs, manage PBRERs, and maintain full audit lineage, without stitching together disconnected tools.
Quality
Watch how Quality Directors use CARA to manage the full GxP document lifecycle, reduce overdue reviews, and close the loop on corrective actions faster.
Clinical
See how clinical teams keep eTMF, protocol documents, and site records aligned, with the traceability and access controls inspectors expect.
Most enterprise AI sits on top of your systems, not inside them. Someone still has to export, move, and reconcile information by hand.
CARA AI doesn’t have that problem, because it isn’t a layer. It’s built directly into the CARA Platform, so every answer it gives inherits the platform’s existing rules.
CARA AI only reasons over current, correctly classified content; never duplicated or exported copies that can drift out of sync with the source.
Every interaction – human or AI – respects the roles, permissions, and retention policies already configured in CARA. Access never widens just because AI is asking.
CARA AI only reasons over current, correctly classified content; never duplicated or exported copies that can drift out of sync with the source.
PBRER highlights without reading 60 pages
Audit reports distilled to what actually matters
100 pages of trial data — clear insights today
Variation narratives and submission documents — not from scratch
PBRER first drafts and RMP annexes from live data
SOPs and CAPAs — first drafts in minutes, not days
Patient narratives and CSR sections — consistently formatted
Label changes checked against your PSMF, RMP, and submission history in one pass
Signal trends across your portfolio — spotted, not missed
Protocol deviations across sites — at a glance
Health Authority query patterns — anticipated before they arrive
Benefit-risk signals surfaced before reporting deadlines
Recurring deviations flagged before they compound
Data lock risks visible weeks before they delay timelines
Submission dossiers in local formats — without starting over
RMP annexes for multiple markets — technically consistent
SOPs across countries — technically accurate, no rework
ICFs in multiple languages — medically accurate across markets
Spend your time driving results, not drowning in documentation
Lower audit exposure with provable lineage
Faster cycles across teams; fewer handoffs
Lower cost per change/submission; fewer surprises
Widely regarded by our customers for our responsiveness, we offer unprecedented care and attention to deliver a high-performing platform for all your needs. CARA now counts over 1,000,000 users across industries worldwide, including 8 of the 10 largest Life Science companies.
© Copyright 2002-2026, Generis Enterprise Technology Limited, all rights reserved