AI for ADE and pharmocovigilance
Auralis powers AI pharmacovigilance automation, ensuring faster adverse event processing, MedDRA coding, and regulatory compliance.
Pharmacological safety teams face mounting pressures: rising case volumes, manual workload, under-reporting, and regulatory deadlines.
90% of adverse events go unreported in clinical practice
Adverse event case volume grows ~15% annually, roughly doubling every five years
Over 50% of safety process activity in pharmacovigilance is manual
$2,900โ12,100 cost per adverse drug case in high-income countries
What if every adverse event reportโfrom EHRs, call centers, portals, or social mediaโwas captured and processed instantly?
What if every case submission was compliant by design, with automated coding, validation, and audit trails?
What if safety teams focused only on medical review and risk analysis, while AI handled intake, duplication checks, and reporting?
Auralis AI agents make this possible, turning pharmacovigilance into a faster, compliant, and scalable process.
Capture reports automatically from call centers, portals, EHRs, and emails.
Apply MedDRA terms consistently with automated NLP.
Guide pharmacovigilance staff with compliant, context-aware responses.
Prepare and file reports with FDA, EMA, and local regulators on time.
Keep safety SOPs, coding rules, and FAQs updated and accessible.
Provide real-time claim tracking and updates.
Surface patterns across ADEs, literature, and social media for early alerts.
Maintain continuous QA and regulator-ready audit trails.
Pharma leaders trust Auralis to scale pharmacovigilance safely and compliantly.
A global pharmaceutical company specializing in cardiovascular and metabolic therapies. With trials across 25 countries and a growing patient base, its safety teams faced increasing case volumes and reporting complexity.
Berne, Switzerland
Pharmaceuticals
150,000+
Our safety teams were overwhelmed by manual intake and coding. Reporting delays exposed us to regulatory scrutiny. With Auralis, we automated adverse event intake and MedDRA coding, halved processing time, and achieved 100% on-time submissions. The impact on compliance and staff productivity was immediate.
Adrian DโSouza
Head of Pharmocovigilance
Routine intake, coding, and duplicates handled by AI
On-time submissions to FDA/EMA with automated workflows.
Every case logged with real-time compliance QA.
Safety staff focus on risk analysis instead of repetitive intake.
Agents handle complex cases without backlogs.
Whether it’s help desks, documentation, videos, CRMs, e-commerce, or customer support tools, Auralis enhances your workflow by integrating with all major platforms. Any platform with an API can be integrated with Auralis
We don’t just implement AI โ we make it work securely and seamlessly for your business. โจStarting from extraction and clean-up to ongoing optimization, we are with you every step of the way
We do the hard work. data clean-up, model training, integrations, monitoring, and maintenance โ all managed by us, so you donโt need a data science team.
Our solutions are shaped around you. We design, train, and optimize AI on your data and workflows. We donโt take generic models and try to fit you in like most of the other solutions in the market.
Instantly integrates with over 500+ tools that your team already uses out of the box. Anything with an API can be integrated with.
Seamlessly orchestrate public and open-source LLMs โ or bring your own โ and deploy them anywhere: cloud, private, or on-premise, with full flexibility to match your infrastructure and compliance needs.
Up and running in days, not months. We deliver measurable results quickly, without lengthy implementations or bloated consulting bills.
Compliance you can trust. Certified to industry-leading security and privacy standards (ISO, SOC2, GDPR, HIPAA-ready).
Choosing the right AI bot can make or break your customer experience. This guide walks you through the key questions to ask and factors to consider before investing in an AI agent for your business.
Looking for details to help you decide?
Here's why Auralis help you start saving today!
Adverse events are reported from many sourcesโEHRs, call centers, patient portals, even social media. Traditionally, staff must collect, re-enter, and validate this data manually. Auralis automates this step by ingesting reports directly from all channels, converting them into structured formats, and flagging incomplete entries. This reduces manual errors, eliminates duplication, and speeds up the time from report to review.
Yes. MedDRA coding is built into the workflow. Auralis uses natural language processing (NLP) to map free-text descriptions of symptoms or incidents to the correct MedDRA terms. The system ensures consistency across all reports, applies updates when MedDRA versions change, and supports custom dictionaries where required. This allows pharmacovigilance teams to maintain accuracy and compliance without expanding manual coding staff.
Auralis generates regulator-ready submissions for agencies such as the FDA, EMA, MHRA, and others. Each case is automatically formatted to meet ICH E2B(R3) standards, with timelines tracked and alerts triggered before deadlines are missed. Built-in validation checks reduce rejection risk, and every submission is logged in a full audit trail. This ensures inspections and audits can be supported at any time without last-minute document gathering.
Compliance is built in rather than checked after the fact. Each case goes through automated quality control at intake, coding, and submission stages. Rules for completeness, timeliness, and coding accuracy are applied in real time. Auralis maintains detailed logs of every interaction, creating a โsingle source of truthโ for inspections. This approach reduces exposure to regulatory fines and strengthens trust with oversight bodies.
Yes. Auralis integrates with leading pharmacovigilance and clinical platforms such as Oracle Argus, ArisGlobal, Veeva Vault Safety, and Medidata. Through APIs, it can connect to EHRs, regulatory submission gateways, and clinical trial data capture systems. This means companies can deploy Auralis without replacing their existing infrastructure, reducing time to value and minimizing disruption.
Auralis is architected to meet HIPAA, GDPR, and ISO 27001 standards. All data is encrypted in transit and at rest, and customer data is never used to train external models. EU data residency options are available for companies with strict locality requirements. Incident response procedures, 24/7 monitoring, and sub-processor transparency ensure security obligations are met. This gives pharmacovigilance leaders confidence that sensitive patient and trial data remain protected.
See what AI-powered support can do for your organization.
