A bespoke clinical trial portal for a paediatric pharmaceutical study

The challenge

Proveca holds a European licence for a medicine treating chronic drooling in children, often associated with neurodisabilities. As part of their ongoing work, they needed to run a clinical study assessing the value of educational materials provided to healthcare professionals and carers.

Running any clinical study comes with strict requirements around how data is captured, stored, audited and analysed. Paper-based case report forms carry real risks, particularly when data needs to be transcribed into a database for analysis later. Electronic alternatives exist, but when Proveca assessed the available options they found the same problem with all of them: they were built for large, complex trials with extensive data requirements, which meant paying for a large amount of functionality that their study simply didn't need.

Proveca also needed to comply with Good Clinical Practice guidelines while keeping patient data fully confidential. That meant different users needed different levels of access depending on their role, which most off-the-shelf tools didn't handle in a way that suited the study's structure.

They needed a software partner who understood bespoke portal development, had experience handling sensitive patient records, and could help with the data analysis side as well.

What we built

We designed and built a bespoke .NET web portal hosted on Azure, scoped precisely to what the study required rather than what a generic clinical trial platform would provide.

The portal gives study investigators a clean, straightforward interface for entering patient visit data quickly and accurately. The format was deliberately kept simple so that clinicians could focus on the study rather than learning a new system.

Underneath, we built a SQL database with a full permissions structure aligned to the GCP access requirements. Different user roles see different data and have different capabilities within the system. Proveca's own admin team can manage user profiles, investigator recruitment and access rights themselves through a built-in admin interface, without needing to come back to us every time someone new joins the study.

Azure was the right choice for hosting given the security requirements around patient data. It removed the need for Proveca to invest in their own infrastructure while meeting the data security standards the study demanded.

Reporting is built in throughout. Proveca can run queries and analyse study data at any point, with complex information available quickly and in context rather than requiring manual extraction and processing.

The portal is fully responsive across desktop, tablet and mobile, which matters when the people entering data are clinicians who may be working from any device during a patient visit.