Case Management and ICSR Processing

Veram Bioclinical Solutions offers comprehensive Case Management and Individual Case Safety Report (ICSR) Processing services, crucial for ensuring the safety and efficacy of pharmaceutical products. Our team is highly skilled in managing the entire process, from case intake and triaging to data entry, coding, and writing narratives. We use standardized dictionaries like MedDRA to ensure consistency and accuracy in coding, and we excel in conducting causality assessments and labeling assessments, essential components of pharmacovigilance.

Furthermore, our quality review and medical review processes ensure that all adverse event reports are thoroughly evaluated, meeting regulatory standards and best practices. We are proficient in expedited reporting to regulatory authorities, ensuring that safety information is reported in a timely manner. Veram Bioclinical Solutions' expertise in case management and ICSR processing ensures that our clients can trust us to handle their pharmacovigilance needs with precision and efficiency, ultimately contributing to the safety of patients using pharmaceutical products.