ICSR Case Processing
Individual Case Safety Reports (ICSRs) are pivotal in pharmacovigilance, serving as a prerequisite for evaluating the risk-benefit profile and ensuring the safe usage of medicinal products.
We manage various sources of Individual Case Safety Reports (ICSRs), encompassing clinical trials, patient support programs, non-interventional studies, disease and product registries, spontaneous reports, literature, legal sources, social media, regulatory authority cases, and cases from license partners.
At Pharmazone, every Individual Case Safety Report (ICSR) undergoes processing adhering to international quality standards in accordance with global regulatory requirements.
We have process
and systems set for:
Exchange with PV partners
Regulatory submission
Follow-up for missing and additional information
Quality check
Medical Assessment
Complete and accurate data entry
Medical Information Receipt and tracking
Downloading adverse event data from authority databases
Adverse event identification
As a comprehensive pharmacovigilance service provider, we monitor global regulatory changes meticulously via our robust Pharmacovigilance Intelligence (PVI) System. PVI consistently assesses the impact of evolving regulations on current pharmacovigilance processes, ensuring regulatory compliance and preparedness for inspections.
We employ a top-tier safety database supported by rigorous validation, secure infrastructure, certifications, and quality assurance. Our team is highly proficient in utilizing all functionalities of the foremost safety databases on the market.