Boosting the development pace and quality of a clinical trial software platform

Overview

Industry

Location

Biotech and Healthcare

USA

Technology Used

Amazon S3

AWS SES

AWS SNS

DataDog

Gitlab

Jitsi XMPP

Keycloak

Kubernetes (EKS)

Microsoft SQL

React Native

React Router

React.js

Spring Boot

Terraform

Project overview

We were tasked with building an independent, fully functional development team to accelerate the pace of development and improve the quality of a clinical trial software platform. We supported our client’s existing teams by strategically providing capabilities where they were most needed, which included scaling up their development capacity, filling critical skill gaps and significantly accelerating their time-to-market. The platform itself is a collection of modular software tools designed to collectively deliver solutions that facilitate clinical trials.

Client background

A provider of modern eClinical tools, founded by a team of industry veterans and technology innovators. The company specializes in developing AI-driven solutions that simplify clinical trial operations, helping study teams accelerate document creation, streamline workflows and manage trials efficiently.

Goals

The goal of the project was to establish a scalable and fully independent development capacity to accelerate the clinical trial platform’s overall development lifecycle. A core focus was placed on enhancing the existing platform's software quality, stability and performance. Furthermore, the project aimed to streamline the development process to significantly reduce time-to-market for new eClinical features and solutions. Ultimately, the partnership involved filling critical skill gaps in the client’s existing teams to ensure comprehensive project coverage.

Results

Accelerated development and quality assurance

The rapid implementation of new features, while simultaneously ensuring high code quality and stability, significantly accelerated the platform’s development.

Streamlined eClinical workflows

The implemented solution led to the successful launch of key modules like eCOA, eConsent, HomeHealth and eSource, each of which reduced manual processes and dramatically simplified operations for study teams.

Enhanced platform performance and scalability

The focus on cloud architecture improved the platform's performance and scalability, creating a more reliable and secure environment for all clinical trial users.

Improved user experience

New features, like offline support and integrated telehealth, enhanced the experience for both study participants and site staff, leading to better engagement.

Assured regulatory compliance and privacy protection

The platform is compliant with standards like FDA 21 CFR Part 11 and HIPAA, with advanced algorithms to redact personal information and keep participant identities confidential.