Abstract

SOFTWARES IN PHARMACOVIGILANCE AND CLINICAL TRIALS

Apoorva B.M*, Kiran L.J and Chethan Kumar S

Abstract

Software plays a crucial role in clinical research Starting from study start up to study close out. Software is accessible at any time from any computer with internet access. It helps investigators, co-ordinators and administrators to reduce burden and facilitate the trial with better communication between research team members. Integration of these software greatly enhance the speed and efficiency in maintaining, managing, planning, performing and reporting of the study data. For clinical trial management certain software like OpenClinica, RealTime-CTMS were used for patient management and recruitment, investigator management, regulatory compliance at the study site and CRO (Contract Research Organization) offices. ClinTrial, Macro, eClinical Suite were used in the Clinical Data Management for CRF(Case Report Form) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management and data extraction by the sponsor or CRO’s, where as Pharmacovigilance software like Argus, ArisGlobal, Pvnet were the drug safety databases used during the study and VigiFlow, VigiBase were used in post marketing surveillance by the sponsor site, CRO’s, hospitals, AMC’s(Adverse Drug Reaction Monitoring Centres) to store the safety profile and adverse event reports of the drug. Thus, these softwares are the great tools in clinical research domain to collect trial specific data to track study performance, schedule, monitor and many more.

Keywords: Softwares, Clinical trial, Pharmacovigilance, adverse events, CRO.