Prudentia has evaluated, developed, and remediated pharmacovigilance processes starting with individual case safety reports (ICSRs) across clinical trial and post marketing (receipt, processing, and submissions), to periodic reporting (PSUR/PBRER, PADER, DSUR, JPSUR, JDSUR), to signal detection, and overall risk management.

Case Processing

We evaluate and design global case processing solutions for companies with a range of ICSR volumes (from fewer than 1,000 cases/year to over 250,000 cases/year). Our experience spans multiple therapeutic areas, multiple geographies (US, EU, Japan, Latin America, South America, Africa, and Australia), and multiple submission types (paper, XML through gateway, XML through portal (EVWEB or WebTrader). We help companies design the PV organization and/or select an outsourcing solution.

Supporting PV Supporting Services

Prudentia understands that PV operations is dependent on several supporting processes. We have experience designing and implementing many of them. We author process documents (Work Instructions / Job Aids, SOPs, policies), training
plans, training curricula, and training materials. We design and implement ICSR compliance monitoring and quality management solutions. We author safety data exchange agreements (SDEAs) and manage the ICSR timelines and other
commitments associated with each agreement. We author and maintain Pharmacovigilance Safety Master File (PSMF). We implement processes for safety database (SDB) master data maintenance, distribution rules, and SDB change control.

Inspection/Audit Readiness

We help organizations prepare for inspections as well as implementing corrective actions from inspections. We conduct mock inspections and conduct audits that are both PV and IT/Systems focused.