Full-spectrum pharmacovigilance — across drugs, devices, and software as a medical device — from a physician who builds the safety systems he advises on.
MedClariva is the independent consulting practice of Dr Varun Kumar Gone — a physician who has spent over thirteen years at the bedside and now works at the intersection of clinical medicine, drug safety, and health technology.
"Most consultants come from one of those worlds. MedClariva is built on all three."
The same judgement that guides a decision on an acute medical ward informs how a safety signal is weighed, how an AI model's output is reviewed, and how a digital health product earns clinical trust.
The practice exists for a straightforward reason. As medicine becomes faster, more data-driven, and increasingly mediated by software, organisations need clinical judgement they can rely on — not as a sign-off, but as genuine accountability. MedClariva provides exactly that, on demand.
A complete pharmacovigilance platform, built end to end and running live — structured ICSR intake, AI-assisted narratives, disproportionality signal detection, risk-management-plan authoring, benefit-risk synthesis, and periodic aggregate reporting aligned to global frameworks (PBRER, PADER, DSUR). Most consultants describe the work; this one demonstrates it.
Safety surveillance across every modality, held to a physician's standard.
End-to-end pharmacovigilance grounded in GVP and ICH principles — for medicines, medical devices, and software as a medical device alike — from individual case review to aggregate reporting and signal evaluation, delivered by a clinician who understands what the data means at the bedside.
Best fit for: small and mid-size pharma without an in-house safety physician, PVCOs needing qualified medical review, and biotech teams preparing for submission.
A clinician in the loop for the products shaping care.
Clinical and safety intelligence for digital health — helping AI, SaMD, and health-technology teams build products that are clinically sound, safe in the real world, and defensible to regulators.
Best fit for: digital health and AI diagnostic startups, clinical-decision-support developers, and healthtech founders who need genuine clinical accountability.
Senior clinical judgement, without a full-time hire.
Independent clinical review, medical writing, and medical-affairs support across the medical-product lifecycle — the perspective of a practising physician, available by project or retainer.
Best fit for: organisations that need experienced clinical judgement on demand, and teams scaling medical and scientific content.
Over thirteen years of frontline clinical experience, international physician qualification, formal pharmacovigilance training, and a working builder's understanding of health technology — in one practice.
Clinician-in-the-loop, not a vendor. Every engagement carries real clinical accountability — the same standard MedClariva would bring to a patient.
The full publication record — spanning SaMD and continuous-biosensor pharmacovigilance, drug safety, and clinical-AI governance — is on ORCID (0009-0002-1639-6428), with new work added on a steady cadence.
Tell me what you're building or what you need reviewed, and you'll get a clear response on how I can help and a defined scope.