Patient safety is the most important element of a pharmacovigilance (PV) system. Therefore, all pharmaceutical and biotechnology companies are required by regulators to identify, collect, and process Individual Case Safety Reports (ICSRs) in a methodical, calculated and robust manner. It is vital to health of a pharmaceutical and/or biotechnology company to report accurate and unbiased data to regulatory authorities in accordance with stringent requirements and timelines.

 

Our PV experts will partner with you to guarantee your case processing requirements are fulfilled in compliance with regulatory legislation.

We have deep knowledge in delivering PV services, and specialize in ICSR processing and analyzing safety data including case intake, data entry, coding, medical review, follow up, quality control, and reconciliation.

 

We support clients by delivering ICSR processing in a fully compliant and validated Argus safety database. Our system is robust and secure. We have a top of the line backup, business continuousness, and disaster recovery procedure in place. Gemini Group’s processes and system are regularly examined and have a best in class history of compliance. In addition, we also have extensive knowledge and experience with all major safety databases.

 

Accelerated and efficient reporting is a fundamental activity in any PV system, and we understand compliance is business critical. Our PV subject matter experts monitor regulatory intelligence and stay up-to-the-minute of any changes in regulations and update core regulatory reporting procedures appropriately.

 

We also have dedicated submissions teams who are qualified for electronic submissions to regulatory authorities.