Real Time Trials uses specifically designed pharmacovigilance and device-safety software and database set to
deliver our outsourced services. Our main safety database is PV-Suite™, a leading product recognised by numerous regulatory agencies worldwide.
PV-Suite is a process-driven pharmacovigilance software system that meets all international regulatory requirements including FDA 21 CFR Part 11. The software implements your business processes ensuring SOP compliance and on-time reporting. An integrated workflow engine generates process-driven “To-do-lists”. Along with comprehensive safety functionality, this gives you full control over your pharmacovigilance operations.
The software allows for comprehensive data entry, which has a complete audit trail of all entries and amendments. Data fields are validated right at the point of entry, including semantic checks (range checks and cross-field checks), which makes coding to MedDRA really simple. Each case that is entered has full eCTD management, where all associated correspondence and reports are loaded, ensuring a complete and transparent document history for each documented case.
The pharmacovigilance database has been designed according to the ICH E2B guideline such that every E2B data field maps to a specific database field. An electronic reporting function, generating all common international regulations (including FDA, CIOMS, EMA, MHRA, AFM, BfArM, AGES) is included to allow for smooth and seamless submissions of regulatory reports and electronic documents.