ArisGlobal
13 Case Studies
A ArisGlobal Case Study
PPD, a global CRO with more than 800 safety professionals, faced the challenge of delivering scalable, cost-effective post‑marketing pharmacovigilance and keeping pace with continually evolving global regulations and reporting requirements. To offer clients a next‑generation, cloud‑based safety database that supports continuous regulatory compliance, PPD partnered with ArisGlobal and selected ARISg as the core pharmacovigilance platform.
ArisGlobal implemented ARISg in the cloud with E2B‑compliant electronic reporting, programmatic case uploads, rapid configuration and client read‑only access, enabling faster case processing and real‑time data review. The solution let PPD submit 33,000 cases to the FDA within two months, generate 260 SIE narratives and 110 death narratives for an ISR/adjudication, and clear a backlog of 55 PADER/PSUR reports within 12 months—delivering improved data quality, faster regulatory responses and on‑time submissions with ArisGlobal’s platform.
Cindy Elko-Simms
Vice President, Pharmacovigilance