Study Protocol, Renewal & Adverse Event (AE) Tracker

Web Development

Screenshots will be added soon

Project Overview

A centralized, web-based system to manage protocol submissions, continuing review/renewals, deviations, and AE/SAE reporting. Streamlines document versioning, approval workflows, deadline reminders, and audit trails for regulatory compliance.

Key Features

  • IRB packet assembly with version control and change logs
  • AE/SAE intake forms with severity grading and routing to safety monitors
  • Timelines, reminders, and evidence repositories for inspections

Project Details

  • Client: PharmaReg Solutions
  • Category: Web Development
  • Completion Date: December 10, 2023

Technologies Used

React.js / Angular (frontend), MongoDB (database), workflow engine

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