Client
A large (10K+ ppl) multinational corporation from New York used Elinext’s help to develop a compliant platform that would allow researchers to manage documents generated during the clinical trials. Our client is the industry leader in practical eClinical innovation. Their software for clinical trials simplifies and automates clinical processes, and a significant part of their development team are Elinext engineers.
Project Description
The web platform, in which development and maintenance were delegated to Elinext teams, allows to store and processing of documentation produced during the Clinical Trials.
An isolated room with enabled possibility to upload documents can be created for each client. Data processing way was to be configured. Processing like editing, conversion, signature, security assignment, metadata assignment and other features were implemented for the seamless work of clinical trials software.
Documents uploaded to the system can be included in Workflow, Audits, Collaborative Review etc. Also available is such support functionality as Q&A, FAQ, Dashboard, Reports, Search, Filters, configurable Views, Users\Groups management, and mobile application.
The development and maintenance of the web platform which enables these features (among others) are the responsibilities of Elinext developers, (A)QA engineers, and DevOPSes.
Challenges
The client had an operating web platform written on outdated technologies. They wanted to rewrite the application using new technologies. They hired a team from India that didn’t have enough experience working on clinical trials software and didn’t do a great job, so they found us to get the job done
The enterprise needed a workforce on several products on the same platform:
- Management System for the documents
- Clinical Trials Management System
- eFeasibility system
- Learning Management System
- Mobile app
- Quality assurance tasks completed within the full regression testing cycle.
Process
Throughout the project, the Elinext team has been working in close contact with the client. The total number of people working on the project is around 250+ ppl, and more than 60 workers are Elinext employees.
During the first two years of cooperation, our team used the waterfall methodology. As our team gradually improved the development process, gaining more experience in clinical trials software, we considered moving to Scrum.
As a result, the Elinext team adopted a system where each release (patch) takes approximately one month to complete. It includes in-house manual verification of the fix made and a full test automation round. For major releases that happen once a year, we run a full regression testing cycle.
Full QA involvement at all stages of clinical trials software development included:
- Requirements analysis based on AHA
- UX designers support
- Manual and automated verifications
- Release management
- SE team support
- UAT/PDC support and automation
- Additional development to support the process
Our teams use Skype and email for daily syncups and Microsoft Teams for planning and demo meetups. In addition, some of our team members have travelled to other countries to meet with the client and discuss further development plans once a year.
Elinext’s team size varied from 8 to 20 people during the early stages of the project. But it later grew, reaching 65 members, including backend and frontend developers, DevOps engineers, and manual and automation QAs.
At the same time, the client has employed about 250 people for the in-house and outsourced parts of the development all around the world.
Solution
From 2009 till now, the Elinext team has been developing a fully functional SaaS platform for clinical trials management and collaboration with the configurable modular interface and securely hosting files in a CFR-compliant centralized virtual data room.
Software for clinical trials is a live application. The development is going for 15 years. Major release once per 10-12 months. Patch release once per month.
In the course of work, the team worked on the following modules:
Module One: User management
The module included the possibility to create users with different roles and available functionality, as well as groups of these users.
Module Two: Documents management
The module includes all the required operations with documents: from creating documents in the system to configuring them, to eSigning, conversion to different formats, audit, export, and many more.
Module Three: Tasks, Q&A, FAQ
Self-explanatory: with the help of this module, one can create tasks and assign them to users, as well as Q&As and FAQs
Module Four: Settings
The module enables the possibility for very flexible system configuration based on the particular client's requirements following which is a must for prolific clinical trials software development.
The remaining four modules are Reports, Dataroom Management, Search, Help & Guides. Each of the modules is responsible for what it has in its title
The team also implemented all dashboards and metrics to review how clinical trials are held with charts, graphs, and diagrams. Using a report module, one can audit any action for the particular study.
Multiple documents can be imported to an archive or export documents’ metadata to HTML, EXCEL, or WORD files.
The system is deployed on 15 servers and has over 50,000 users. Testing documentation preparation and auditing comply with 21 CFR Part 11 guidelines. That shows our expertise in clinical trials software development.
Besides that, our DevOps team continuously working on test and production environment support. We automated the application deployment process to prevent any human mistakes and decrease the downtime of the servers.
Results
The project is ongoing, this is one of the biggest and most lucrative cooperations Elinext has with its customers.
New features are delivered on time, with major releases annually. We brought a lot of value to the platform with our consultation and expert opinions on the project, our client got clear feedback. Few long-awaited features had been implemented.
This is a live project that includes 3 multitenant servers and 10+ dedicated servers. New features are under development all the time. Additional side applications are under development. The customer is more than just satisfied with our services, the cooperation and work on software for clinical trials has been running for decades, and it doesn’t seem to be over shortly.
Related Case Studies
Our expertise extends beyond this project, as we have successfully delivered multiple solutions in related domains:
