Healthcare SaaS

Enterprise Clinical Trial Management Platform

Architecting a fully regulated, multi-tenant eClinical platform supporting the end-to-end lifecycle of clinical trials — from sponsor onboarding to patient data collection, IoT device sync, and FDA audit-ready reporting.

The Problem

Fragmented Operations & Regulatory Burden

Clinical trials are among the most operationally complex processes in modern medicine. Pharmaceutical sponsors, site investigators, and patients often work across fragmented systems — paper-based consent forms, manual CRF entry, disconnected patient communication channels, and no unified audit trail.


The regulatory burden (FDA 21 CFR Part 11, HIPAA, ICH-GCP) further compounded every technical decision. Without automated audit trails, immutable e-signatures, and role-based PHI controls, passing FDA and GCP audits relied heavily on manual documentation. Furthermore, decentralized trial models were impossible, limiting trial reach and increasing patient dropout rates.

Features & Solutions

End-to-End Trial Lifecycle Platform

Lifecycle Management

Sponsor registration, study & site setup, subject enrollment, visit scheduling, ePRO/eCOA diaries, eCRF data capture, drug supply, eTMF — all in one governed platform.

Electronic Consent

eConsent module with video recording, digital signatures, and time-stamped audit events satisfying 21 CFR Part 11 and ICH-GCP requirements.

IoT & Wearable Integration

Integrated seven health device platforms (Fitbit, Oura, Apple Watch, Dexcom CGM, Withings, ActiGraph, Circul) via OAuth2 and REST APIs into BigQuery.

Decentralized Trials

VideoSDK-powered in-app consultations enabled fully remote trial participation, unlocking decentralized clinical trial (DCT) models without site visits.

My Role

Director of Engineering & Architect

FDA 21 CFR Part 11 HIPAA ICH E6(R2) GCP GxP EU Annex 11 SOC 2 GDPR
  • Led the architecture, engineering, and delivery of the entire 34-module platform.
  • Translated complex clinical trial workflows and regulatory requirements into technical systems design.
  • Owned the system architecture document (SADD) and drove technology stack decisions.
  • Managed distributed cross-functional teams across parallel workstreams.
  • Collaborated directly with pharmaceutical sponsors, clinical operations directors, and regulatory leads.
  • Established CI/CD pipelines, code review standards, and SOPs to ensure audit-readiness and engineering predictability.
  • Led third-party compliance audits and maintained documentation governance throughout.
Tech Stack & Tools

Technologies Used

Laravel 5.8 (PHP) MySQL 8.x Redis React.js Vue.js React Native Ionic GCP BigQuery GCP Compute Engine OAuth2 Firebase FCM
Business Impact

Measurable Results

34
Functional Modules Delivered
7
IoT Platforms Integrated
7
Distinct User Roles w/ PHI Access
0
Critical Findings in Audits

  • Enabled pharmaceutical sponsors to run fully decentralized clinical trials (DCT) — removing geographic barriers.
  • Eliminated paper-based CRF and consent processes, reducing transcription errors and accelerating data review.
  • Passed third-party regulatory audits with zero critical findings, thanks to compliance-by-design architecture.
  • Continuous patient health metrics captured in real time via wearable integrations, enriching outcome data.
  • Multi-country deployment supported through language management and configurable study protocols.