Intake
Omni-source case capture: spontaneous, literature, programs, and digital channels, deduplicated and triaged by AI at the front door.
>40%
reduction in processing cost
>50%
reduction in aggregate reporting time
Walk onto any safety floor. Safety experts are keying case data, chasing duplicates, and formatting narratives. Aggregate reports get dirty data and take months from DLP to complete. Signal detection is reactive and slow. The most expensive judgment in the company is doing the least judgment-heavy work.
And volume only moves one way. New products, new markets, patient programs, and social channels. A model priced per human touch breaks a little more each year.
Intake, triage, data extraction, narrative generation, and quality checks are becoming machine work with human oversight at defined gates. Routine cases will flow end to end with near-zero touches.
Regulators and leadership judge safety organizations on how early they see risk. Signal detection, evaluation, and benefit-risk management become the center of the function, staffed by the experts case processing used to consume.
Real-world data, patient programs, wearables, and social listening widen the intake far beyond spontaneous reports. Only automated pipelines with intelligent triage can drink from that firehose compliantly.
Health authorities are building expectations for AI governance in pharmacovigilance (PV). Validated systems, documented human oversight, and audit-ready decision trails become license to operate.
Every shift rewards the same thing: safety run as an automated, governed intelligence system with human oversight. That is the box we deliver.
Omni-source case capture: spontaneous, literature, programs, and digital channels, deduplicated and triaged by AI at the front door.
Insights from signal and risk activities feed back into surveillance, helping refine what the system monitors.
See how a top-three pharma reduced processing costs by 59% while achieving 97% accuracy with AI-powered automation.
Insights from 100 PV professionals across the USA and Europe, representing various seniority levels.
Explore the latest FDA REMS updates, ETASU requirements, and technology advances improving safety and patient access.
End-to-end ICSR handling with low touch and no touch automation tiers.
Continuous, multi-source surveillance with expert evaluation and documentation.
PSURs, DSURs, and PBRERs authored with AI assistance and expert sign-off.
RMPs, REMS support, and risk minimization measure design and tracking.
Automated global and local literature monitoring with intelligent triage.
Validated automation, audit-ready oversight models, and inspection support.
Touchless case processing uses AI to automate intake, triage, extraction, coding, narrative generation, and quality checks for routine ICSRs, with human oversight at validated control points.
Indegene runs this model through low-touch and no-touch tiers designed for compliance and scale.
PV organizations reduce cost per case by automating repetitive steps, standardizing workflows, and reserving expert intervention for exceptions and high-risk signals.
Indegene combines automation with governed operating models to lower case costs while protecting quality and timeliness.
The shift from cases to signals means safety teams spend less effort on manual processing and more on identifying, evaluating, and acting on emerging risks earlier.
Indegene enables this by moving routine case flow to automation and redirecting expert time to surveillance and benefit-risk decisions.
AI in pharmacovigilance is inspection-ready when systems are validated, human oversight is defined, and end-to-end decision trails are audit-ready.
Indegene builds these controls into delivery so health authority inspections can trace how automation decisions were made and governed.
Share your case volumes, data sources, and current cost per case with us. Indegene can assess the current operating model and develop an automation blueprint, compliance governance model, and cost-per-case improvement path.
Get the PV automation diagnostic.