Built by clinical safety experts, biostatisticians, and compliance engineers.
Zen Health was founded to solve two of clinical development’s most critical operational vulnerabilities: unverified pharmacovigilance case review and uncalibrated trial protocol feasibility.
In safety, sponsors delegate case processing to CROs but bear 100% regulatory liability when inspections occur. In clinical trials, fragmented protocol authoring and guesswork around enrollment timelines trigger multi-million dollar amendments and delayed market entries.
We built Zen Case AI and Zen Protocol AI to change that. Physician-centered, mathematically grounded, and strictly non-authoritative. Engineered for the medical review team that demands defensible case quality—and the clinical researchers launching tomorrow's breakthrough trials.
Meet the Team Building Zen Health
A multidisciplinary team of engineering, clinical R&D, product design, and executive leaders committed to advancing patient safety and clinical trial execution.
Soumyadip Ghosal
Building Zen Health, transforming pharmacovigilance medical review (Zen Case AI) and ICH M11 clinical trial protocol intelligence (Zen Protocol AI).
Archanaditya Sarkar
CHIEF OPERATING OFFICER
Sayan Dey
CHIEF TECHNOLOGY OFFICER
Rajdeep Ghosh
HEAD OF ENGINEERING
Amit Gorai
PRODUCT DESIGNERBoard of Advisory
Delivered by the named principals
Dr. Praveen Vadlamudi
Physician-Entrepreneur | CEO @ Aetos Healthcare | Scaling RPM, CCM, BHI & AI-Driven Virtual Care
Sherifuddin Sheriff Shaik
Physician | Clinical Research Expert | Medical Advisor to US & EU Pharma | BE Studies & Global CRO Oversight
Elias Tharakan
Architect of the industry's first unified EDC + RTSM + eCOA + Safety suite, powering 1,000+ trials across 90+ countries.
Dr. Ashok Srivastava
MD, Ph.D., MBA
Board-certified oncologist. 135 trials, 11 first-in-human, 27 INDs, 9 NDAs, 3 BLAs including AUCATZYL® (obe-cel) CD19 CAR-T.
Built for Clinical Safety, Trial Integrity & Audit Readiness
Omnichannel Ingestion & Standard Normalization
Connects directly to EMR/EHR, EDC, and safety databases (Argus, ArisG, Veeva). Incoming clinical data is normalized to FHIR R4 and ICH E2B(R3) schemas with quarantine logging for invalid payloads.
Deterministic Calculations & Monte Carlo Simulation
Eligibility rules (Criteria DSL) and feasibility simulations (Poisson-Gamma accrual) are computed strictly with deterministic statistical code, avoiding generative AI math hallucinations.
Credentialed Physician & PI Adjudication
Named board-certified physicians and Principal Investigators confirm, edit, or override AI recommendations with mandatory rationale capture. AI is strictly non-authoritative.
21 CFR Part 11 & Append-Only Audit Trails
Database-level triggers enforce write-only ledgers for audit records, reviews, and dual electronic signatures with OTP re-authentication. Produces inspection-ready exports for global health authorities.
Get in touch.
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