Drug Safety and Pharmacovigilance Services
★ Pharmacovigilance/Drug Safety is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products.
★ Our team supports safety analysis right from the planning of investigator brochure to review of epidemiology data on large scale.
★ Astranix is equipped with fully supported safety database solutions like Argus Oracle health science safety and Arisglobal lifesphere safety multivigilance. Both systems are 21 CFR part 11 fully compliant safety solutions.
Our Pharmacovigilance services
★ Case Processing
★ Expedited Reporting
★ Aggregate Reporting(PSUR, PBRER, DSUR, PADER, PAER, SSUR)
★ Signal Management
★ Risk Management Plan