A Chenvar HealthtechMedClarivaTM
A pharmacovigilance platform combining structured safety operations, medical review, regulatory workflows, validation and competency development.
MedClariva is not a case-management tool with extras. It is built around the whole safety lifecycle, and each stage is mapped to the module that carries it — with its build status stated.
Operations, practice, assessment and utilities — kept distinct so each can be evaluated, deployed and validated on its own terms.
The modules are layers of a single system, not fifteen separate products. A case entered once is the same record that a signal, a periodic report, the PSMF and an inspector later rely on.
Structured, coded cases feed signal detection and every periodic report.
Signal and benefit–risk conclusions feed the RMP, the periodic reports and the PSMF.
Oversight draws on every record above; Inspection Readiness assembles it for the inspector.
Regulatory rules and role separation govern what each user can see, do and sign.
The ICSR layer is designed as a chain: each step hands a controlled record to the next, so the E2B(R3) representation is derived from governed data rather than assembled at the end.
The E2B(R3) representation is in development. MedClariva makes no claim of E2B(R3) conformance, gateway submission readiness or acceptance by any authority. That claim will be made only against a declared, validated baseline.
A safety system is defensible when every change can be traced to a requirement, a release, a test and a person. These controls are part of the architecture, not a module added before an inspection.
Requirements mapped to implementation and verification evidence.
Identifiable software releases and controlled configuration states.
Documented test execution against defined requirements.
Controlled records, attribution, timestamps, signatures and history.
Deployment status, development status and validation status are independently declared.
| Product | Deployment | Development | Validation |
|---|---|---|---|
| PV SuiteSafety operations | Pilot access | Operational build | Validation in progress |
| ICSR / E2B(R3) layerWithin PV Suite | Not released | In development | Not claimed |
| PV AcademyCompetency assessment | Private beta | Operational build | Not applicable |
| PV SandboxSimulated workflow | Not released | In development | Not applicable |
| PV ToolsOpen utilities | Available | Operational build | Not claimed |
Built for teams that need structured, traceable and scalable safety operations — and have to demonstrate them to an inspector, a partner or a licensor.
PV professionals and learners: see PV Academy and Sandbox.
The competency layer of MedClariva. Academy teaches and assesses; Sandbox gives controlled, simulated experience. Together they produce evidence that a person can do the work.
Structured learning built on a fictional safety database and a versioned reference-safety corpus.
Private betaSimulated end-to-end workflow in the Sandbox, against synthetic data.
Not releasedCase files scored on causality, seriousness, expectedness and submission decisions — judgement, not recall.
Private betaA record of assessed performance that an employer or a sponsor can rely on.
Private betaSome decisions in pharmacovigilance are medical. For those, MedClariva provides qualified safety-physician input alongside the platform.
MedClariva was founded by Dr Varun Kumar Gone, a consultant physician in internal medicine who designed its clinical architecture himself.
The consequence is practical: the system was designed with a physician’s understanding of clinical safety information — what makes a case serious, what makes a narrative usable, and where a reviewer’s judgement has to be recorded rather than inferred.
Full record on ORCID.
Or discuss your PV operation first. Tell us what you run today and what you want the platform to take on.