OUR PROCESSES CONSIST OF:
– Standard Operating Procedures
– Safety Management Plan
– Working procedures
– Forms and templates

PHARMACOVIGILANCE SERVICES:
– Review of Clinical Study Protocol
– Set-up of DSMB, DSMB reports
– Set-up and maintenance of safety database, SAE handling manuals
– Medical review of SAEs and follow-up
– Medical assessment of causality and expectedness
– Expedited reports (SUSARs) to CAs and ECs/Investigators
– SAE tracking and update of SAE documentation
– Coding (MedDRA, WHO-DD, ATC)
– Generation of CIOMS-I forms and line listings
– SAE reconciliation
– Periodic Safety Reports (PSURs)

Patient safety narratives are written with input provided by the Assign
cross-functional team, who are reviewing all available data and information
(e.g., pharmacovigilance database, clinical trial database, CIOMS forms,
hospital records, case report form).