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, etc. 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
Benefits Delivered
  • Accelerated solution launch timeline by 20%
  • Delivered HIPPA, FDA (Medical Regulations) compliant solution mitigating regulatory risk associated with medical trials