Tenancy at the database
Row-level security enforces who can see what. Application bugs cannot leak across tenants.
Platform
MedClariva. The safety record.
Software a drug-safety function runs on, and training that proves the people running it can do the work. Status is stated plainly on every entry.
Pharmacovigilance
Medclariva
Pharmacovigilance technology and structured drug-safety training, for marketing authorisation holders, safety service providers and the people who staff them.
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PV SuiteSafety operations
Fifteen modules across ICSR management, signal detection,
aggregate reporting, literature surveillance, benefit-risk, RMP authoring, CAPA,
PSMF, QPPV oversight and inspection readiness. Multi-tenant, audit-logged, with
electronic signatures on every controlled action.
In production
02
PV AcademyCompetency training
Case-based assessment against structured rubrics, built on a
fictional drug safety database. Learners work real case files and are scored on
causality, seriousness, expectedness and submission decisions — not on
multiple choice.
Private beta
03
PV SandboxPractice environment
A safe environment for teams to run end-to-end safety
workflows against synthetic data before touching a validated system.
In development
04
Free toolsOpen utilities
Browser-based ICSR extraction and E2B(R3) validation, running
entirely client-side so no case data leaves the machine.
Available
Architecture
How it is built.
What makes a safety system defensible is not its feature list. It is whether every change can be traced to a person, a time and a reason.
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Writes through controlled procedures
No direct table writes from a client. Every change passes through a procedure that validates, authorises and logs it.
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Append-only audit
Audit records cannot be edited or deleted, including by administrators.
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Signatures on controlled actions
Actions that carry regulatory weight require an attributable electronic signature with a stated reason.
Get in touch
Tell us what you are building.
Partnership, pilot, procurement or investment — enquiries are read and answered by the founder, not a queue.