Successful pharmaceutical development, achieving safety results that protect both your investment and your patients requires perceptive management of Serious Adverse Event (SAE)/Adverse Event (AE) monitoring, analysis, and reporting. Pharmacovigilance safety database is the central repository for individual case safety reports or ‘ICSRs collected for a company’s medicinal product(s) from all sources globally. It is very important to ensure pharmacovigilance safety database is kept up to date with the latest regulatory requirements and validated to meet both international standards and business requirements. Because safety databases facilitate the reporting of individual and aggregate safety data to authorities and third parties and provides key information for the detection of safety signals and the ongoing evaluation of the risk-benefit profile of the company’s product(s).We provide technical services/staffing/solutions for the following Drug Safety applications:
Both systems 21 CFR part 11 fully compliant safety solutions which are an essential part of Good Pharmacovigilance Practice. They are accurate and accessible databases which allow rapid assessment of data for signal detection, aggregate report production and statutory electronic reporting of cases to the regulatory authorities.