Pharmacovigilance software for teams that need enterprise capability without enterprise cost
A complete drug safety system covering the full ICSR lifecycle — multi-channel intake, AI-assisted extraction, coding, assessment, regulatory submission, signal detection, aggregate reporting, and QMS — delivered as fully hosted SaaS or a dedicated single-tenant deployment.
Why safety teams outgrow their current system
Most pharmacovigilance teams are not short of process — they are short of a system that matches the size of their operation. The options have historically been a legacy enterprise platform priced and scoped for large marketing authorisation holders, or a spreadsheet-and-email workflow that cannot survive an inspection.
Implementation measured in months
Legacy enterprise deployments run multi-month implementation cycles before the first case is processed — a timeline that does not fit a CRO winning a sponsor contract this quarter.
Licensing priced for large enterprises
Heavy per-seat licensing and a large infrastructure footprint push the total cost of ownership beyond what small-to-mid pharma and CROs can justify against their actual case volume.
Manual work that should not be manual
Re-typing case data from PDFs and emails, coding by hand, and tracking reporting deadlines in a spreadsheet consumes the time of the qualified people you hired for judgment, not data entry.
An audit trail assembled after the fact
When the evidence of who decided what, and when, lives across mailboxes and shared drives, inspection preparation becomes a reconstruction project.
PVgenix delivers the core drug-safety capability of an enterprise platform on modern, cloud-native technology — provisioned in days rather than months, at a cost profile built for CROs and small-to-mid pharma, with the audit trail captured as work happens rather than reconstructed afterwards.
One system for the full safety lifecycle
Cases move from intake through submission and on into surveillance and quality management on a single connected record — no exports between modules, no separate gateway product, no second system for periodic reporting.
Multi-channel case intake
Email, messaging and social channels, a web reporter portal, and file-based and API intake, with configurable forms and validation rules per tenant.
See how it worksAI-assisted extraction and coding
Automated extraction from PDFs, emails, and narratives with confidence scoring — with a qualified person reviewing and approving before a case proceeds.
See how it worksCase processing and assessment
Duplicate detection, follow-up versioning, seriousness logic, causality, expectedness against version-controlled reference safety information, and MedDRA / WHO-DD coding.
See how it worksRegulatory submission and exchange
A regulatory clock and rules engine, E2B(R2)/E2B(R3) generation, CIOMS I and MedWatch 3500A outputs, and a built-in AS2 gateway with acknowledgement reconciliation.
See how it worksLiterature monitoring
Scheduled searches, automated screening and triage, AI-assisted ICSR identification confirmed by a reviewer, and an article-to-case workflow.
See how it worksSignal detection
PRR, ROR, BCPNN/IC, and EBGM disproportionality methods with masking detection, configurable thresholds, and signal lifecycle management.
See how it worksAggregate reporting
DSUR, PBRER/PSUR, and PADER support with line listings and summary tabulations generated from one interval query at the data lock point.
See how it worksQuality management
Integrated CAPA, deviation, and change-control tracking with quality review workflows tied back to the cases that raised them.
See how it worksWhat makes PVgenix different
The comparison that matters is not feature checklists — it is what the system costs to run, how quickly it is usable, and who is left holding the manual work.
Rapid provisioning
The initial SaaS platform build takes roughly three days plus three days of setup documentation. After that, each new tenant is self-provisioned from the portal with no IT-team involvement. These are IT-setup timelines, not your full qualification effort.
No separate gateway licence
Gateway software is usually a separate product with its own licence and its own qualification scope. PVgenix ships AS2 inside the platform, on the same audit trail as the case that produced the file.
One codebase, two deployment models
Multi-tenant SaaS for CROs and teams without an IT function, or a dedicated single-tenant environment for data-residency-sensitive clients — with feature parity, because both run the same product.
AI that assists rather than decides
AI accelerates extraction, coding, and screening. Causality, expectedness, and seriousness sign-off stay with your qualified PV personnel, and every AI-assisted step is captured in the audit trail.
Validation-ready documentation set
A complete IQ/OQ/PQ package plus VMP, URS, FS, DS, RTM, and SOP templates are provided to support your qualification, with GxP, GAMP 5, and 21 CFR Part 11 alignment designed in.
Built for multi-client operations
Tenant isolation, per-tenant configuration and entitlements, and per-sponsor compliance reporting — the operating model a CRO needs when one team serves many sponsors.
Answers before the demo
The questions that come up in most evaluations. If yours is not here, ask it on the call.
Browse the full FAQPharmacovigilance software — also called a drug safety system or safety database — is the regulated system of record for adverse event data. It captures individual case safety reports (ICSRs) from every reporting channel, supports coding and medical assessment, generates and transmits regulatory submissions such as E2B files, and supports ongoing surveillance through signal detection and periodic aggregate reporting. Because it holds regulated records, it must provide access control, electronic signatures, and a complete audit trail.
Yes. PVgenix is multi-tenant by design: each sponsor is a logically isolated tenant with its own configuration, workflows, code lists, reporting rules, and access control. Once the initial platform is live, each additional tenant is self-provisioned from the portal with no IT-team involvement, and compliance metrics such as on-time submission rate are reported per sponsor.
The initial SaaS platform build takes approximately three days of IT provisioning plus three days for setup documentation handover. A dedicated single-tenant environment takes approximately three days to set up plus four days of documentation. Each new tenant after the initial build is provisioned from the portal with about one day of documentation. These figures cover IT provisioning and documentation handover only — your qualification execution, SOP authoring, UAT, and operational go-live are client-led and take additional time.
PVgenix is designed around 21 CFR Part 11, EU GVP, GAMP 5, and GxP principles, with role-based access control, electronic signature capture, tamper-evident audit logging, and tenant data isolation. It is delivered validation-ready and audit-ready with a complete IQ/OQ/PQ documentation package. Compliance in practice is environment-specific: qualification is executed against your environment, requirements, and SOPs, and that execution is owned by you or your QA/CSV team.
Yes. Region hosting options (including EU, US, and India) are available to support GDPR and sponsor-contract data-residency requirements, and a dedicated single-tenant deployment can be provisioned in the environment you require when full isolation and environment control are needed.
Yes. Third-party dictionaries and licensed content — including MedDRA and the WHO Drug Dictionary — must be procured and licensed by you. PVgenix integrates them into the application, including admin-controlled version management, but does not supply or license them.
Pricing depends on deployment model, tenant count, case volume, and the scope agreed for your requirements, so it is quoted per engagement rather than published as a list price. PVgenix is deliberately positioned at a lower platform and hosting cost than legacy enterprise systems, without heavy per-seat licensing. Our guide on pharmacovigilance software cost breaks down the cost components to compare before you request a quote.
See PVgenix on your safety operations
Request a 30-minute demo and we will walk the platform through your intake channels, reporting obligations, and review workflows.