One safety platform, every sponsor kept separate

For a CRO the deciding criteria differ from a pharma buyer's. Four matter most: tenant isolation you can evidence during sponsor due diligence; per-tenant configuration of reporting rules, workflows, code lists, and reference safety information without a vendor ticket; the cost and elapsed time of onboarding each additional sponsor; and per-sponsor compliance reporting such as on-time submission rate computed by the system. Core case processing tends to look similar across a shortlist — these four do not. Our CRO buyer's guide covers the full evaluation questionnaire.

In multi-tenant SaaS, data is logically isolated per tenant with tenant-scoped role-based access control on a least-privilege model, encryption in transit and at rest, and tamper-evident audit logging of every access and change. Where a sponsor contract requires physical separation, that client can be deployed as a dedicated single-tenant environment with an isolated application and database, optionally in a specified region. Both models run the same codebase.

After the one-time initial platform build — approximately three days of IT provisioning plus three days of setup documentation — each new tenant is self-provisioned from the portal with no involvement from our IT team and about one day of documentation. Those figures cover IT provisioning and documentation handover only. Sponsor-specific configuration, your qualification activities, SOP updates, UAT, any data migration, and training sit on top and are led by you, so plan sponsor go-live dates against your own timeline rather than ours alone.

Yes. Reporting rules, workflow states and review gates, intake form fields and validation, code lists, MedDRA and WHO-DD versions, reference safety information, notification and escalation rules, branding, and entitlements are all configured per tenant from the admin console. Study-specific reporting rules can be configured per protocol for clinical-trial cases, so one sponsor's multi-market post-marketing obligations and another's single-study SUSAR reporting coexist without conflict.

Yes. Submission tracking computes on-time submission rate from the submission records themselves, scoped per tenant and per authority, with overdue and at-risk queues surfaced to an accountable owner before a deadline passes. That is the compliance KPI most sponsor contracts require monthly, so it comes out of the system rather than out of a manually maintained tracker.

Yes, on the same case structure and the same audit trail. Clinical cases additionally support SUSAR identification and expedited handling, a blinding and unblinding workflow, and study and protocol configuration with study-specific reporting rules — which matters for CROs whose sponsor mix spans interventional studies and marketed products.

Not us. PVgenix is a software development provider: we build and deliver the application, the environment setup, and the supporting documentation. All pharmacovigilance decisions, regulatory interpretation, safety assessments, SOP content, and compliance obligations remain with the client and their qualified PV personnel — whether the QPPV sits with your CRO or with the sponsor is a matter for your safety data exchange agreement.

Case data can be exported in E2B format — the vendor-neutral transfer standard — along with source documents and attachments, supported by data migration tooling for field mapping and reconciliation where required. Settle export rights, formats, timelines, retention period, and any associated cost as contractual points before signing with any vendor, including us.