NOVO PROVIGILANCE LLC

Individual Case Safety Processing (ICSR) is reporting of patient drug safety information to Regulatory Authorities in an expedited and non-expedited way. Processing of ICSRs with consistent quality and ensuring Regulatory timeline compliance is one of the primary responsibilities for the organization. NOVO PROVIGILANCE is inclined for this accountability.

• ICSR process starts with the receipt of cases from various sources – solicited (cases from clinical safety) and unsolicited (cases from healthcare professional and non-healthcare professional).
• Acknowledge and check the case validity, legibility and completeness.
• Performing triage, bookin of the cases and performing data entry in the global safety database.
• Perform quality and Medical review of each ICSR in the global safety database before finalizing the case.
• Generate and submit the CIOMS and MedWatch 3500 A drug reports to the appropriate Regulatory authority.

We provide case processing services covering all therapeutic areas. By providing and maintaining the latest Industries standards including lean strategies, to reduce case processing time and maintaining quality, accuracy, consistency and traceability are the fundamentals of our standards.