Safety Technology, Reconciliation & Device Vigilance

“Establish a single global safety database with unified end-to-end workflows, secure cloud-based architecture, and open integrations.”

“Within one system, sponsors and CROs process and manage global and domestic adverse events for drug, biologic, vaccine, device, and combination products.”

“Outsourced Complaint & Adverse Event Reports (AER)”

“…Our global vigilance team comprises experts in clinical safety and vigilance for drugs (Pharmacovigilance), medical devices, food supplements, and cosmetics.”

“…To truly protect patients and anticipate regulatory expectations, safety teams need a deeper understanding of how a product is performing in the real world. But the data is…”

“…From regulatory strategy to medical device clinical investigation management and post-market surveillance & vigilance activity, we provide tailored, integrated regulatory…”

“…We provide post-approval safety monitoring to ensure your product remains in good standing with COFEPRIS — managing spontaneous adverse event reports, periodic safety reporting…”

“Veristat offers comprehensive and proficient support for pre-approval and post-market Pharmacovigilance (PV) and Medical Information (MI) services across various categories of…”

“The EVIDEX® background rate analysis tool provides an instant, cost-effective way to calculate background incidence rates of adverse events for specific conditions — all within a…”

“Tag, track, and route adverse events from multiple sources. Quickly flag potential issues, create tasks, and ensure timely follow-up while maintaining a robust audit trail for…”

“ASAP is the first validated active safety analytics custom built solution for the Life Sciences industry.”

“Since 1999, we have been analyzing healthcare data to identify side effects earlier, improve patient safety and outcomes, and guide better treatment decisions.”