Safety & Pharmacovigilance Services

• Individual Case Safety Report (ICSR) processing and identification: At CUREXBIO, we ensure accurate collection, processing, and identification of ICSRs to maintain patient safety and regulatory compliance.
• Regulatory submissions (DSUR, PSUR/PBRER, PADER/PAER, periodic reports) : The basis to meet regulatory standards and compliance, is the timely preparation and submission of periodic safety reports
• Literature monitoring: To identify potential and emerging safety information for ongoing PV, CUREXBIO supports continuous monitoring of medical and scientific literature.
• Safety data evaluation and signal detection: To detect safety signals and enabling proactive risk management, CUREXBIO evaluates the safety data on demand.
• Safety database configuration and oversight (Oracle Argus or client platforms): For ensuring data integrity and compliance with global standards, CUREXBIO configures and manages safety databases.
• Benefit-risk analysis and risk management planning: To improve patient safety, we perform stringent benefit-risk analysis and implement risk management plans.
• EudraVigilance assistance : Assuring seamless communication with European Authorities with timely reporting and maintaining compliance with EudraVigilance
• In-licensed and out-licensed products management: CUREXBIO supports lifecycle management and market compliance by overseeing safety and regulatory obligations for licensed products.

We offer support for clients, ensuring seamless pharmacovigilance management from first-in-human trials to post-marketing phases. Our expert team and recognized processes fulfil compliant, superior safety reporting, constantly and on schedule.