On a pharmacovigilance platform, patient safety has the highest priority. In order to comply with the regulatory standards and guidelines, a company must identify, gather, and process ICSRs in a systematic and comprehensive manner before reporting to regulatory authorities, as an essential element of the pharmacovigilance system. The reports for products used during pregnancy, medication errors, off-label use, misuse, abuse, and other “special scenarios,” pertinent to the safe use of the pharmaceutical product are collected and managed through our robust pharmacovigilance system.

This data is then compiled from all available sources, including unprompted patient and Healthcare Professional (HCP) reporting, international literature, business partners, post-marketing studies, other solicited data gathering initiatives, and company-managed social media.

Our expert team can provide case file management, including collection, data filing, indexing (coding), medical evaluation, and follow-up, by providing such information to the client and reporting to relevant regulatory agencies, IRB, EC, and with investigators.