The Utrecht University Medical Center has used Mendix’s enterprise low code solution to create a powerful Research Online Platform application, which is now used by 6,500 end users in 45 countries

The European Medicines Agency (EMA) will collect data from at least 60,000 participants and conduct analytical studies
The key to the success of the Research Online Platform, built on Mendix’s low-code platform, is its flexibility and scalability
New features have been added to meet EMA requirements, such as repeated assessments
Beijing, China, February 24, 2022 – Mendix, a Siemens business, a global leader in the development of enterprise low-code applications, recently announced that Utrecht University Medical Center (UMCU), one of the largest public healthcare institutions in the Netherlands, has built a flexible workflow-driven digital questionnaire to help improve the quality of the system. To help some European countries document side effects of COVID-19 vaccines and booster vaccines for specific groups of people, the data will all be automatically submitted to the European Medicines Agency (EMA) for further study. The logic and content of the questionnaire was developed by Lareb and has now been integrated by UMCU into the institution’s mature Research Online Platform, built on Mendix’s enterprise low-code platform. The Research Online Platform helps researchers manage data when conducting large-scale global clinical studies.

Secure cloud environment and scalability

The Research Online Platform is currently used by 6,500 end users in 45 countries, including researchers, nursing researchers and monitors, and processes approximately 400,000 forms submitted by more than 350,000 respondents each year. In addition to developing complex workflows for large, long-term studies, the Research Online Platform enables researchers to collect global data in a secure cloud environment that complies with applicable laws and regulations such as the Good Practice for Quality Management of pharmaceutical Clinical Trials (GCP).

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With a survey of around 60,000 to 100,000 participants, one of the main challenges the study faced was the scalability and capacity of the platform. UMCU chose to replicate the Research Online Platform so that they could respond quickly even as the number of participants grew. In addition, in order to meet EMA’s research requirements, UMCU has set up relatively complex workflows and developed new capabilities.

Developing new features at a record pace

A special feature of this workflow is “repeat evaluation,” where side effect data entered before the query can be tracked in the next evaluation. For example, if a vaccinator reports signs of headaches at the first assessment, the app will automatically ask the vaccinator if they still have headaches at the second assessment. The use of corresponding repeated assessment questions to assess different side effects is the first of its kind. In addition, the auditor was a newly developed role in this study, using a universal dictionary to determine which category the side effects entered by vaccinators in an open message board fell into. For example, if a vaccinator enters “chills,” the auditor will record this side effect as “flu symptoms.”

After vaccinators register through an online form, a system called SLIM creates a profile for the user. SLIM will create anonymous users in the Research Online Platform, and to avoid matching research data with personal information, the data of the two systems is strictly separated. In the study, UMCU developers also developed the ability for others to fill out questionnaires on participants’ behalf.

Joost Schotsman, head of data management at UMCU’s Health Sciences Center, said: “I think the Research Online Platform is the best platform for this research, both in terms of scalability, flexibility and compliance. Because of the urgency of the EMA’s request, we are very pleased with the involvement and assistance of the Mendix experts. By working together, we are able to act quickly to prevent compromises on the availability and reliability of our research results.”

Joelle de Prez, Customer Service Manager at Mendix, said: “The Research Online Platform has become the technical basis for many clinical studies and is constantly evolving and improving. With its flexibility, the platform can carry out a variety of new research relatively quickly, standing out in the fierce market competition. We are very pleased that UMCU has chosen Mendix’s low-code platform to build this important new module, giving us the opportunity to contribute our expertise to this project.”