Reimagine Pharmacovigilance as a Data-Driven, Real-Time Signal Intelligence Engine.
As drug portfolios expand, global regulations tighten, and patient-generated data grows exponentially, yesterday’s manual or semi-automated PV systems fall short — in both speed and scope.
When PV practices fail to evolve, Life Sciences organizations face:
of drug recalls are tied to post-market safety signal oversight
of MAH inspection findings relate to late or incomplete adverse event submissions
Pharmacovigilance must move from reactive case processing to proactive, end-to-end safety intelligence.
Auto-generated CIOMS, E2B (R3), and XML packages for FDA, EMA, PMDA, CDSCO, and others
Shared annotations, audit logs, and reviewer workflows with version control
Visual SLAs and escalation workflows to meet regional regulatory reporting deadlines
Monitor product-specific safety trends, cohort anomalies, and risk ratios over time
Reduce manual workload while improving signal consistency and clarity
Consolidate case records across regions, affiliates, CROs, and legacy systems into a unified repository
NLP engines to identify duplicates, prioritize critical events, and extract relevant entitie
Capture adverse events from call centers, mobile apps, physician portals, social media, and wearables — in real time
Capture adverse events from call centers, mobile apps, physician portals, social media, and wearables — in real time
NLP engines to identify duplicates, prioritize critical events, and extract relevant entitie
Consolidate case records across regions, affiliates, CROs, and legacy systems into a unified repository
Reduce manual workload while improving signal consistency and clarity
Monitor product-specific safety trends, cohort anomalies, and risk ratios over time
Visual SLAs and escalation workflows to meet regional regulatory reporting deadlines
Shared annotations, audit logs, and reviewer workflows with version control
Auto-generated CIOMS, E2B (R3), and XML packages for FDA, EMA, PMDA, CDSCO, and others
In today’s environment, PV isn’t just about reporting — it’s about protecting patients, reputations, and market continuity.
We bring technology, automation, and compliance alignment together to help Life Sciences companies evolve their PV practices for both performance and accountability.
Deploy only what you need: intake, triage, coding, signal detection, or regulatory submission modules
Extend or enhance your existing infrastructure without starting from scratch
Automatically score and flag case reports for missing fields, ambiguity, or risk content
Trigger workflows based on market-specific timelines, seriousness criteria, or compound class
Track how fast signals are emerging — and how early you’re catching them
Audit trails, training logs, and dashboard views to prepare for any PV inspection or authority query
From intake to signal to submission — one interface for PV leads, compliance teams, and safety scientists
With INT., PV becomes a unified, transparent, and agile operation — not a bottleneck.
Let’s benchmark your current PV operations against industry best practices — and identify areas to automate, scale, and safeguard.
You’ll receive:
We go beyond maintaining operations—we empower businesses with data, insights, and best practices to stay ahead in an ever-evolving digital landscape.