Case study: ePRO

We were contacted by Clincase to work on a new kind of project for them - we were to build a mobile application that would expand their business to a new market.

Challenge

Clincase is a long-standing company that has been handling medical data for their customers already for fifteen years. Until now, they've been mostly focused on their EDC (electronic data capture) software. However, they've noticed the trend to offer more patient-oriented approach to data from clinical studies and decided to expand their client offering by giving them a complex system that would take care of the whole process: from gathering data from subjects during a clinical trial, through data validation up to storing it in the EDC software for easy access later on.

However, that meant a completely new set of technical challenges: they needed to provide both devices and software for the subjects to use during their 2-year trials. As this was a new platform for them and there is a lot of strict requirements over the software quality and reliability they needed someone with the right experience to help. That's where we came in.

There were various requirements in this project that made it particularly challenging:

• To satisfy the strict data correctness requirements, the subjects needed to be able to enter data wherever they are - even when offline. That means we needed to build an offline-first solution with client-side data validation, submission queues and graceful handling of any connectivity problems.
• Of course, medical data is highly sensitive and its storage is covered by strict regulations. That means we needed to make sure it's encrypted at all times and protected from any unauthorized access.
• There was a series of requirementes that related not only to the app that we were about to build, but also to the device itself. For example, it needed to be locked down to only allow this particular app to be used by the subject.
• Reliability is paramount, the release process for medical software is complicated and we can't really "push a quick fix". On top of that, any mistakes connected with data entry or storage could invalidate the whole medical study, so the price to pay for bugs was extremely high.
• Lastly, the solution needed to give a smooth user experience even in the tightly resource-constrained environment of a low-end Android device that it was run on.

Process

We built the application as a React Native Android application, running inside a MDM solution that provided kiosk-mode functionality. It was tricky to get a smooth navigation experience with the low-end device that was to be used for the trials, but we managed to get satisfying application performance.

Offline processing

The offline requirement was another difficult one to handle, but with clever use of cryptography we managed to offer even a completely offline identity verification, which along with data encryption and implementing a request queue for data entry allowed the application to work completely offline.

Updating kiosk software

Another aspect that usually proves to be difficult for kiosk-mode applications is updates. We can't rely on the user to perform any update actions, nor can the device be regularly accessed by maintenance staff. Fortunately, basing the application on React Native helped us in that case, allowing us to use Code Push to provide smooth update experience with version reporting and verification.

Reliability

We followed all the industry best practices to ensure software correctness. We used TypeScript throughout the whole application to get compiler checks, not a single line of code could be added without a detailed code review, we wrote automatic tests and performed rigorous manual testing (both by the development team themselves, as well as outside testers).

However, our service wasn't limited only to writing code.

We worked closely with Clincase on every step of the way: from advising on the design, through choices of hardware and software to use, up till the final stages when we were assisting during the training calls with medical staff that will be overseeing the studies.

Results

The application is currently used in a 2-year long clinical trial that spans five countries and hundreds of subjects. Also, we're adjusting the application to become more configurable and able to easily handle different types of studies in more of a SaaS style.

Throughout the project Clincase gathered a lot of experience connected with launching a new type of service and handling new types of technical challenges.