Auriga Research Private Ltd

Auriga Research Pvt Ltd is CRO offering Pharmacovigilance and Clinical Trials Services for Drugs, Device, Vaccine and Ayush Products. The Auriga Safety System (PV Database) is a cloud based easy to use, regulatory compliant, end to end Pharmacovigilance / Drug safety system. It is an all-in-one system that provides PV Intake, Case processing, AI, Analytics, Submissions /AS2 gateway and Safety signals capabilities under one platform. Here is the PV Services offered by us • Maintenance of PV Safety database for Drug/Vaccine/Device • Management of PV System Master File (PSMF/PvMF) • ICSR Case Processing and Reporting • Literature review and Surveillance • Periodic Aggregate Report Writing (PSUR/DSUR/PBRER/PADER) • SDEA Review and Execution • Training of team including setting up required SOPs for PV activities • Risk Management Plans & Risk Evaluation and Mitigation Strategies • Signal Detection, Assessment & Management • VAERS (Vaccine Adverse Events Reporting System) • Medical Device Vigilance (Materiovigilance) • Post Marketing Surveillance Studies • Pharmacovigilance Audit We offer end-to-end clinical trials services including Medical Writing, Regulatory Submission, Site Management, Monitoring, Data Management, Statistical Analysis and Clinical Study Report. The clinical trials operations are performed by using the following tools. • Master Data Management (MDM) – For maintaining of a database of sites and investigators. • Clinical Trial Management System (CTMS) for project management • eTMF for Trial master files and investigator site files to organize and store documents, • rSDV for remote monitoring and remote source data verification. • EDC system for creating and implementing eCRF at sites for data management. • Electronic QMS and eLearn We also offer Bioequivalence Monitoring, Pharmacokinetic Analysis and Cosmetic product studies safety & efficacy studies (IS4011:2018).