PPD and ArisGlobal | A Pharmacovigilance Success Story

PPD, a CRO with over 800 safety professionals, wanted a modern, cloud-based way to help clients manage pharmacovigilance compliance efficiently. It partnered with ArisGlobal, drawing on ArisGlobal's 30+ years of industry experience, to deploy a cloud-based drug safety database giving clients read-only access, rapid new-client configuration, E2B-compliant XML submissions and streamlined case processing. Documented results: within two months of signing, PPD submitted 33,000 cases to the FDA via programmatic upload with no manual entry; PPD produced 260 special interest event narratives and 110 death narratives with source documentation on schedule for an FDA ad hoc report; and PPD cleared a backlog of 55 periodic adverse drug experience/safety update reports for oncology and anti-infective products within 12 months, meeting all overlapping deadlines.

ArisGlobal makes the LifeSphere suite — safety-case management, signal detection and clinical systems used by pharmacovigilance and clinical-operations teams.

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.