We capture individual case safety reports from every source, around the clock, ensuring no adverse event goes unrecorded and every case enters processing complete and accurate.
Case Intake & Data Entry
Efficient collection and entry of Individual Case Safety Reports from multiple sources, ensuring data completeness and accuracy.
Source Verification
Verification of case information from healthcare professionals, patients, literature and partners to ensure reliability and compliance.
Electronic & Paper Intake
Support for both electronic and paper-based ICSR submissions, including email, fax and web portal intake.
Follow-up Management
Proactive follow-up with reporters to obtain missing or clarifying information for robust case documentation.
Data Quality Review
Comprehensive review of ICSR data for accuracy, consistency and regulatory compliance prior to case processing.
Regulatory Compliance
Ensuring all ICSR collection activities meet global and local regulatory requirements and audit standards.
Secure Data Handling
Implementation of secure systems and processes to protect sensitive safety data and ensure confidentiality.
Integration with PV Systems
Seamless integration of ICSR collection with pharmacovigilance databases and workflow tools.
