HIPPA compliant Clinical Trial Management Solution

Client Overview

US based healthcare startup offering next generation solutions for smart clinical trials including automated drug delivery, patient vitals monitoring & drug adherence

Business Challenge
  • Creating an innovative solution that would reduce complexity while maintaining effectiveness of clinical trials, reducing the time lines of clinical trials and increase patient engagement
  • Required expertise on HIPPA, FDA healthcare standards to make the solution compliant
VOLANSYS Contribution
  • Designed, developed Node and Angular based web application as well as React based iOS mobile application to monitor patient vitals such as blood pressure, pulse, weight-through end devices connected over BLE
  • Added support for health devices in web and mobile application (over BLE) to collect and monitor patient’s vital data
  • Implemented encryption on data storage and exchange using AES-256 to secure the confidential patient information
  • Developed patient log storage to maintain and check trial history of patient
  • Deployed clinical trial application on AWS cloud
  • Integrated Nodemailer with web and mobile application to send promotional and transactional emails to client’s customers
Technologies | Engineering Expertise

HIPPA | AWS Cloud | BLE | iOS | Connected Mobile Application | Web Application | FDA (21 CFR Part 11) | My SQL | Node.js | React | Testing

Solution Architecture
VOLANSYS-Clinical Trial Management Solution
Benefits Delivered
  • Accelerated solution launch timeline by 20%
  • Delivered HIPPA, FDA (Medical Regulations) compliant solution mitigating regulatory risk associated with medical trials