Scale your safety operations as your pipeline grows

Safety reporting obligations begin with the first dose in humans, so the system, its qualification, and the SOPs around it need to be ready before first-in-human dosing rather than alongside it. Because expedited SUSAR timelines are short and unforgiving, most teams want the system in place with time for qualification and training before the first patient is enrolled. IT provisioning on PVgenix takes about three days plus three days of setup documentation; your qualification and SOP work sits on top of that and should drive the timeline you plan against.

Study cases are assessed for seriousness and for unexpectedness against the version-controlled reference safety information in force, and cases meeting SUSAR criteria are routed to expedited handling. The regulatory clock determines Day 0 and the applicable expedited timeline per region, deadlines are tracked per obligation with alerts before breach, and the configurable rules engine resolves which authority receives which report in which format. The SUSAR determination itself is a regulated judgment made by your qualified PV personnel.

Treatment assignment remains blinded to the processing team, and unblinding is a controlled workflow step rather than an informal request — when it occurs, who performed it and when is recorded on the audit trail. Blinding requirements are configured per protocol, so studies with different arrangements coexist without a process workaround.

Yes. Study and protocol configuration covers study-specific reporting rules, reference safety information, blinding requirements, and expedited criteria, administered by your team without a code change. That matters more in clinical work than in post-marketing, because obligations vary per protocol by design, by region, and by any partner agreement in place.

Yes. DSUR outputs are generated from your study case population at the data lock point, including line listings and cumulative and interval summary tabulations, with every figure traceable to the case versions included at lock. The authored content and interpretation in the report remain with your qualified PV personnel; the platform supplies the data, the tabulations, and the traceability.

Out-licensing creates a safety data exchange obligation with the partner, usually formalised in a safety data exchange agreement. PVgenix supports licence-partner case reconciliation and clinical-versus-safety database reconciliation with a discrepancy tracking and resolution workflow. Note that the agreement itself — who reports what to whom, on which timeline, and how reconciliation runs — is a pharmacovigilance and legal matter owned by you and your partner, not something the software decides.

No. Post-marketing capability is part of the same platform: multi-channel spontaneous intake, literature monitoring, signal detection, and PBRER/PSUR support. A first marketing authorisation means configuring post-marketing obligations and reference safety information rather than migrating your clinical safety history into a different system — which is the point at which many growing companies otherwise face an expensive replatforming.