Safety Database

Safety Database has a crucial place in today’s pharmaceutical industry. Patient safety is the prime and most important goal for pharmaceutical companies across the globe. With Safety Database, we will get one step closer to that.

The Safety Database acts as a repository for the Individual Case Study Reports (ICSRs) of the company’s products. It makes it easy to report and aggregate the safety data to third parties and the authorities. Along with that, these reports will also provide key information for the ongoing safety signals detection and risk-benefit evaluation of a particular product. All these reasons make it highly vital to make sure that the safety database of Pharmacovigilance is up-to-date according to the latest reporting requirements to meet the needs of regulatory compliance.

 

IGRS Services include -

• Complies with all current and emerging regulations, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.

• One solution to handle PV intake, case processing, submissions, analytics, and safety signals.

• Easily configurable dynamic workflows for expedited case processing.

• Provides powerful and actionable insights.

• End-to-end ICSR case-processing activities bundled with the PV safety database.

• PV safety database services (hosting, servers, implementation, upgradation, maintenance, and support).

• MedDRA & WHO DD Access, Upgradation, and Maintenance.

• Legacy PV Safety Database Migration.

• Electronic Gateway Profile Creation Services.