Case Processing & Reporting
In pharmacovigilance, case processing is the essential activity that delivers data for the investigation of adverse effects that allows to notice new safety concerns and to intermittently evaluate the benefit to risk ratio related with the use of a pharmaceutical product. In order to ensure accurate analysis and take remedial step which in turn helps to protect patient health and allow safe drug use, processing safety data with precision and quality is essential. The majority of regulatory agencies require a safety services document called an individual case safety reports (ICSR), which cotains the information needed to report adverse events, product related issues, and consumer complains regarding any drug products.
Published scientific and medical literature is a important basis of data for monitoring safety profile and risk benefit balance of medicinal and biological products as well as medical devices, particularly in relative to the recognition of new safety signal or emerging safety issues.
Services offered:
• Receipt and triage of initial and follow-up cases SAEs, AESIs, SUSARs, ICSRs, regulatory cases
• Data entry
• MedDRA coding
• Similar Events Analysis
• Medical analysis/assessment
• Narrative writing
• Case closure
• Generation and distribution of follow-up queries
• Global expedited case reporting
• EudraVigilance reporting using EV Web and E2B (R3) compliance
• Reporting to Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators
• Reconciliation with external data collection partners (CROs, affiliates, partners, etc.)