Mobile adverse event reporting

Mobile adverse event reporting

Itransition developed a cross-platform mobile application that allowed healthcare organizations to automate adverse event reporting and improve patient care.

Case study

Mobile adverse event reporting

Customer

Our customer is a UK-based SaaS provider working in the pharmaceutical sector and delivering solutions used by top 30 global pharma organizations. The company focuses on drug safety and adverse event reporting solutions that ensure patient protection and product data quality.

The customer’s flagship product is a SaaS platform that allows medical specialists and patients to submit information about drug side effects and product complaints in real time. The platform simplifies pharmaceutical data collection and thus contributes to drug safety.

Objective

Side effect reporting becomes even more streamlined when the reporter can do it on the go, but there were no such mobile solutions on the market. So the customer decided to extend their web-based solution with a mobile application that would automate adverse event data capture and provide the opportunity to do it anytime and anywhere.

The customer chose Itransition to deliver the solution thanks to the previous successful collaboration and our hands-on experience in mobile application development for healthcare.

Solution

Itransition delivered a cross-platform mobile application that automates adverse event reporting and enables medical specialists and patients to submit all the necessary information on the go. The application ensures the standardized intake of product quality data and allows for remote collaboration between patients, clinicians, and pharma organizations.

The delivered solution supports the following user roles:

  • Healthcare professionals submit adverse reactions or patient complaints using their mobile devices, being able to capture and process critical data any time and at any location, without interrupting their workflow.
  • Patients report concerning symptoms without a doctor’s appointment, which streamlines adverse reporting and ensures patient engagement.

The application supports the offline mode with data synchronization, thus providing the opportunity to fill in concerning symptoms in any setting.

Besides, delivered as a SaaS product, the application provides white‑labeling support. It empowers organizations that adopt the solution to maintain total control of their brand through interface design and functionality customization.

Basic workflow

When a patient or a healthcare professional needs to report an adverse reaction, they log into the system and choose “Create New Report”. Then, they fill in the necessary information, including the suspect product that caused an adverse event, adverse event description, start date and end date, and contact information. The application also provides for intelligent questioning, triggering additional questions based on user’s responses.

After filling in the required information, users can review it and submit the report. The collected data is automatically transferred to a safety database that is used by pharma organizations to improve drug safety and minimize patient risk.

Workflow

Compliance and security

Due to the sensitive nature of the collected information, we ensured that the solution met HIPAA and GDPR standards.

Our team performed testing to detect rooting (for Android) and jailbreaking (for iOS) to ensure the protection of all the critical data, including personal health information. We also implemented SSL Pinning and added an extra encryption layer to guarantee secure client‑server communication and ensure uncompromised transmission of sensitive information.

Process

Itransition was the sole vendor responsible for application development, QA, and support. Since the scope of work and customer requirements were clear, we opted for the Waterfall development methodology. Yet, in the testing phase, we found out that some new functionality that was added throughout the project was not clearly described in the initial requirements. It was necessary to review the new functionality case by case in order to find out whether the change was a bug or a described feature. Therefore, our team turned to the Kanban methodology. This shift allowed us to quickly resolve appearing bottlenecks, improve prioritization, and get faster feedback from the customer, which also resulted in faster cycle times.

To ensure stable, predictable, and repeatable delivery process, during the project we set up and followed continuous integration and delivery (CI/CD) practices with continuous code review and quality assurance.

Our team was also responsible for the solution support and maintenance. We performed bug fixing activities and feature improvement, including GDPR form updates and moving offline‑submitted reports synchronization into a background process.

Technical overview

We developed the application using Xamarin.Forms toolkit. It consists of three modules, including an iOS application, an Android application, and a Portable Class Library that allows for centralized code sharing.

The reports are generated dynamically based on Journey Configuration. The report form consists of a set of fields divided into several screens. We developed the form using the Dynamic Form Rules so that the fields behave differently based on specific conditions. For example, field A is displayed only when field B has a certain value.

Results

Itransition delivered a cross-platform mobile application that automated adverse event reporting, enabling patients and healthcare professionals to capture, process, and report adverse event data on their mobile device in real time. The mobile application together with the customer’s web-based solution streamlined the reporting process leading to:

  • 95% reduced manual efforts associated with report creation
  • Twice more submitted reports
  • Twice faster report creation process
  • Timely feedback on drug safety