Automating PV Case Intake and Triage

With the volume of adverse events increasing, organizations need to rapidly and cost-efficiently ingest relevant Safety cases into their PV database from an ever-expanding array of structured and unstructured data sources, including adverse event reports, medical literature, field case reports, and more.

To help expedite this process, we offer comprehensive case intake AI and automation, powered by the LifeSphere NavaX cognitive computing engine. Industry-leading capabilities such as GenAI-powered data extraction offer unmatched efficiency gains.

See the value of automation in PV case intake and triage, including:

• Driving up to 65% case intake efficiency gains with Advanced Intake, including GenAI-powered data extraction and narrative generation.
• Enable up to 70% faster reference processing using Literature Intelligence to automate the intake and management of medical literature.
• Enable up to 50% faster field case reporting with Reporter, utilizing secure mobile and web applications that enable real-time PV and medical information collection.

An Accelerated Approach to PV Case Processing

After Safety cases are ingested , organizations then need to accelerate the entry of cases into the PV database, automating key case processing workflows, including the reviewing, updating, and verification of incoming cases.

Amid skyrocketing case volumes, we provide comprehensive AI and automation, powered by LifeSphere NavaX, to offer significant time and cost savings in case processing, without compromising precision or regulatory compliance.

Accelerate case processing with our MultiVigilance solution, including:

• Creating case narratives with GenAI-powered Narrative Generation.

• Driving up to 80% efficiency gains with automated MedDRA coding.

• Automating product coding using CPD and WHODD.

• Automating follow-up, including query generation and correspondence.
• Streamlining quality and medical review via intuitive user interfaces.

Streamlining PV Case Submissions and Reporting

Once Safety cases are processed, it’s time for the submission and reporting of those cases, including generating and distributing regulatory submissions and reports to Health Authorities and other key global stakeholders.

To help fulfill global regulatory requirements, LifeSphere Safety solutions enable organizations to streamline and automate workflows across safety document distribution, real-time reporting, PV aggregate report authoring, and more.

Key benefits include:

• Accelerated global distribution using Document Distribution to send information to clinical sites, health authorities, and other key stakeholders.

• Robust, real-time Safety insights with Business Intelligence for reporting and sharing information with internal stakeholders, as well as partners and affiliates.
• 70% faster medical authoring using Advanced Compliance Docs to automate the creation of aggregate reports and other content generation.

Enhanced Signal Review and Assessment

Organizations need ways to rapidly identify and prioritize potential safety concerns that can arise for review and further assessment to comply with regulatory standards, minimize risk, and ensure optimal patient outcomes.

To address these needs, our Advanced Signals solution was designed to enable up to 80% faster case assessment in signal detection, including proprietary case completeness scoring to help prioritize high-quality and well-documented cases, as well as provides advanced analytics through Signals Intelligence for even deeper signaling insights.

Realize the Value of End-to-End PV AI and Automation Today

It’s time to operationalize AI and automation across the end-to-end pharmacovigilance (PV) ecosystem.

ArisGlobal is the trusted leader in Safety, with over 40 years of experience, and processing 12 million cases annually for over 220 organizations, including 60% of the Top 10 Pharma.

Now, by utilizing our industry-leading LifeSphere Safety platform, supported by our team of hundres of experts, it is possible to go live with industry-leading AI and automation across the PV lifecycle in months, not years, delivering tangible value you can see.

From case intake and processing, through submissions, reporting, and signal assessment, gain access to advanced AI and automation technologies powered by LifeSphere NavaX, to deliver unmatched time and cost savings today.

Ready to see how LifeSphere Safety can operationalize AI and automation across the full PV lifecycle?

Discover what leading life sciences organizations around the globe already have. Operationalize end-to-end AI in PV today with LifeSphere Safety.