Pharmacovigilance

We offer high responsive, customised pharmacovigilance services which are industry-standard compliant, ranging from small studies to complex, large multinational clinical studies and registries. Our pharmacovigilance services can be deployed individually or as a package.

SOCAR offers the following pharmacovigilance services:

	Design, development and implementation of the complete Adverse Event database
	Data entry of adverse Events reports for trials using paper CRFs
	Complete e-management of SAE reports for trials using e-CRFs
	Data query resolution and management
	Quality Assurance and Quality Control
	Patient narrative development
	Evaluation of medical integrity and completeness of the reported event
	Coding and validation of coding using MedDRA
	Periodic safety update reports