ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling. We specialize in efficient ICSR case processing and accurate ICSR reporting to support pharmaceutical companies in meeting global regulatory requirements.
DISCOVER MOREOur Comprehensive ICSR Pharmacovigilance Approach
Patient safety is at the heart of our process. Our approach integrates robust systems for collecting and managing safety-related data from diverse sources—including healthcare providers, patients, clinical studies, and scientific literature—to conduct in-depth cause-and-effect analysis. This process ensures that every adverse event, whether serious or non-serious, is captured and evaluated.
We leverage our expertise in ICSR case processing to transform raw data into actionable insights. By focusing on every aspect of the process, we help mitigate risks and enhance the safe use of medicines, thereby reinforcing our commitment to deliver high-quality individual case safety report services and overall patient care.
Our ICSR Processing & Submission Process
At DDReg, we adhere strictly to both global and national standards for ICSR Case Management. Our process covers all key stages—from case receipt, duplicate checks, and triage to data entry, quality checks, and comprehensive medical reviews. We ensure that every report is processed using E2B(R3) compliant databases integrated with WHO Drug Dictionary and MedDRA for seamless ICSR reporting.
In addition, our system maintains rigorous monitoring, tracking, and reconciliation processes with our customers. This structured methodology supports efficient ICSR reporting and addresses every detail of case processing steps in pharmacovigilance, ensuring precise and timely safety case processing for all submissions.
Our ICSR Case Processing Expertice
- Receiving adverse drug events, medical information queries, and product quality complaints
- Triage of initial and follow-up ICSRs, including SUSARs
- Case processing through E2B(R3) compliant systems integrated with WHO DD and MedDRA
- Quality checks and detailed medical reviews
- Timely submission of cases as per agency timelines
- Maintaining ICSR monitoring and tracking systems
- Reconciliation processes with customers
Ready to optimize your ICSR pharmacovigilance process and enhance your ICSR case processing?