Independent Medical Consulting

Dr. Varun
Kumar Gone

MD · MRCP (UK) · ECFMG Certified · Hyderabad, India

Where clinical precision meets pharmacovigilance rigour and the intelligence of tomorrow's medicine.

Pharmacovigilance Clinical AI HealthTech Advisory Medical Review
VKG
13+
Years Clinical
MRCP
Royal College UK
GVP
PV Certified
3
Service Pillars
Scroll

A Clinician at the
Intersection

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.

🎓
MD Internal Medicine
Nizam's Institute of Medical Sciences
🏛️
MRCP (UK)
Royal College of Physicians, London
🌐
ECFMG Certified
International Medical Recognition
🛡️
GVP · ICH Certified
Oracle Argus · MedDRA · ICSR
"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.

Dr Varun Kumar Gone
Founder, MedClariva · MyCliniLedger · MyMediLedger

What MedClariva Does

I
🛡️
Pharmacovigilance & Drug Safety
GVP · ICH · Signal Management

Drug safety, held to a physician's standard.

End-to-end pharmacovigilance support grounded in GVP and ICH principles — from individual case review to aggregate reporting and signal evaluation, delivered by a clinician who understands what the data means at the bedside.

  • Medical review and quality oversight of ICSRs
  • Aggregate reports — PBRER/PSUR, DSUR, PADER authoring and review
  • Signal detection, evaluation, and benefit–risk assessment
  • Medical literature surveillance and causality assessment
  • PV system, SOP, and inspection-readiness advisory
  • Medical monitoring and safety-physician support for clinical trials

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.

II
🤖
Clinical AI & HealthTech Advisory
SaMD · AI Medical Review · Digital Health

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.

  • Clinical validation strategy and evidence design for AI/SaMD
  • Post-market safety frameworks and algorithm-change governance
  • AI medical review — clinical oversight, annotation and ground-truth review
  • Digital health regulatory and clinical-content advisory
  • Clinical product strategy for EMR and clinical decision-support platforms

Best fit for: digital health and AI diagnostic startups, clinical-decision-support developers, and healthtech founders who need genuine clinical accountability.

III
⚕️
Medical Review & Medical Affairs
Independent Review · Scientific Communications

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.

  • Independent medical and clinical case review
  • Scientific and medical writing — reviews, manuscripts, regulatory and educational content
  • Medical-affairs support — scientific communications, advisory-board preparation
  • Field-medical content development
  • Clinical training and content for health products

Best fit for: organisations that need experienced clinical judgement on demand, and teams scaling medical and scientific content.

A Combination That
Rarely Sits in One Person

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.

13+
Years Clinical
3
Service Pillars
Global
Remote-Ready
🇬🇧
MRCP (UK) Qualified
International physician qualification from the Royal College of Physicians, London — a globally recognised standard of clinical excellence, exceptionally rare among India-based internists.
⚖️
GVP & ICH Trained
Formal pharmacovigilance training: GVP modules, ICH-GCP, Oracle Argus Safety, MedDRA, APVASC, and ICSR processing — regulatory rigour grounded in clinical practice.
🤖
AI-Era Physician
Active healthtech founder building real clinical software. Published voice on the safety of AI and Software as a Medical Device. Uniquely positioned to evaluate and advise AI medical products.
🌏
Global Reach
ECFMG certified. Fluent in FDA, EU MDR, and CDSCO regulatory frameworks. Available for remote consulting engagements across geographies and time zones.
📄
Published Author
Active research pipeline spanning sepsis immunotherapy, SaMD pharmacovigilance, digital health, and AI governance — peer-reviewed and preprint publications.
🎯
Senior Engagement Only
Every engagement is personally led by Dr Gone. No junior handoffs, no outsourcing. Your work receives senior physician attention from brief to delivery.
Domains

Areas of Expertise

Pharmacovigilance & Drug Safety
GVP · ICH · Signal management · Aggregate reporting
Software as a Medical Device
SaMD safety · AI governance · Post-market surveillance
Clinical AI Evaluation
Medical review · Ground-truth annotation · Clinical accuracy assurance
Internal Medicine & Critical Care
13+ years frontline · Complex case review · MRCP (UK)
HealthTech & Clinical Product Strategy
EMR · Clinical decision support · Digital therapeutics
Medical & Scientific Writing
Manuscripts · Regulatory content · Scientific communications

Built on Verified
Expertise

Clinical Qualifications
Pharmacovigilance & Regulatory
Ventures & Authorship

Credentials at a
Glance

MRCP (UK) — Royal College of Physicians MD Internal Medicine — NIMS ECFMG Certified Oracle Argus Safety MedDRA Coding ICH-GCP ICSR Processing APVASC Clinical Trials — Johns Hopkins Drug Discovery — UC San Diego PG Diploma Cardiology — NYHA PG Diploma Endocrinology — RCP London MRCP (UK) — Royal College of Physicians MD Internal Medicine — NIMS ECFMG Certified Oracle Argus Safety MedDRA Coding ICH-GCP ICSR Processing APVASC Clinical Trials — Johns Hopkins Drug Discovery — UC San Diego PG Diploma Cardiology — NYHA PG Diploma Endocrinology — RCP London
ORCID Verified
https://orcid.org/0009-0002-1639-6428
All qualifications independently verifiable

A Published
Clinical Voice

Commentary · Preprint · 2026
From Pills to Pixels: Why Software as a Medical Device Will Redefine Pharmacovigilance
Therapeutic Innovation & Regulatory Science · DOI: 10.5281/zenodo.20439278

Further publications on sepsis immunotherapy, liquid biopsy in oncology, GLP-1 receptor agonist safety, and digital health pharmacovigilance forthcoming. A steady cadence of clinical commentary published here.

Three Ways to
Work Together

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.

Advisory Call
A focused session to pressure-test a safety, regulatory, or clinical-product question. Clear, accountable, senior physician perspective.
Project Engagement
Defined scope and deliverables — from a single aggregate safety report to a complete SaMD post-market surveillance framework.
Retainer / Fractional
Ongoing safety-physician or clinical-advisory capacity, without a permanent hire. Available by month or quarter.
Email
drvarunpv@gmail.com
📍
Location
Hyderabad, Telangana, India
🌐
Availability
Remote · Worldwide · Flexible
Send an Enquiry