Efficient collection and entry of Individual Case Safety Reports (ICSRs) from multiple sources, ensuring data completeness and accuracy.
Verification of case information from healthcare professionals, patients, literature, and partners to ensure reliability and compliance.
Support for both electronic and paper-based ICSR submissions, including email, fax, and web portal intake.
Proactive follow-up with reporters to obtain missing or clarifying information for robust case documentation.
Comprehensive review of ICSR data for accuracy, consistency, and regulatory compliance prior to case processing.
Ensuring all ICSR collection activities meet global and local regulatory requirements and audit standards.
Implementation of secure systems and processes to protect sensitive safety data and ensure confidentiality.
Seamless integration of ICSR collection with pharmacovigilance databases and workflow tools.