Datatalk-CA Information

DataTalk Inc. keeps pharmacovigilance systems running, compliant and inspection-ready for biopharma companies. We specialize in Oracle Argus Safety and the E2B infrastructure around it: Argus Interchange, Axway B2Bi gateways, AS1/AS2 connections with health authorities and partners, and the move to E2B(R3). Our principal consultant, Calogero Alaimo, has worked with Argus since 2001 for companies including BioMarin, Gilead, Exelixis, CSL Behring and Bayer. What we do: • Argus Safety system ownership and support: configuration, reporting rules, E2B profiles, upgrades and patches • E2B(R3) implementation, hypercare and trading-partner onboarding (FDA, EMA, PMDA, MHRA and others) • Axway B2Bi gateway upgrades, migrations and certificate management • Computer System Validation under GAMP 5, 21 CFR Part 11 and EU Annex 11 • SQL validation of aggregate reports (PADER, DSUR, PSUR, line listings) • Disaster recovery and infrastructure for safety systems, on-premises and on AWS We work on an interim, part-time or project basis, remotely across the US and on-site in California. Contact: info@datatalk-ca.com