Building a multi-tenant clinical trial platform for European healthcare

Clinical trials are among the most regulated activities in European healthcare. Every study requires protocol design, ethics approval, patient recruitment workflows, data collection governance, and regulatory readiness across INFARMED, EMA, and national standards. These tasks are fragmented across email, disconnected spreadsheets, paper forms, and vendor-specific systems. A single trial's design phase consumes three to four months of coordinated work from R&D, compliance, patient services, and regulatory teams — even before patient enrolment begins.

Worthmed, a clinical research organisation based in Portugal serving hospitals and research centres across Europe, saw this inefficiency as a structural market problem. Their customers — from Hospital CUF Descobertas to academic medical centres — were losing competitive advantage because they couldn't move from protocol concept to regulatory submission quickly. The cost wasn't only lost time. Delayed trials meant delayed patient access to new treatments and delayed revenue for sponsors.

They came to Twistag with a concept: a single platform where a clinical team could design a protocol, manage approvals, coordinate with multiple sites, and submit a regulatory package — all in one system. We built it from first principles as a full-stack product.

What we learned

Twistag designed the platform as a multi-tenant operating system for clinical research workflows, not a bolt-on tool. That meant starting with data: we modelled the entire clinical trial lifecycle — protocol structure, site networks, regulatory templates, audit trails, and patient cohorts — into a normalised PostgreSQL schema that could scale across hundreds of concurrent studies without compromise.

The frontend is Blazor WebAssembly, which gave us a key advantage: we write C# on both client and server. That shared language meant faster iteration, fewer type mismatches between UI and backend, and a smaller attack surface for healthcare security reviews. The backend runs on .NET Core using gRPC for inter-service communication instead of REST, reducing latency for real-time collaboration and cutting bandwidth significantly when teams build protocols in parallel.

FHIR compliance was non-negotiable. We built the platform to emit and consume FHIR bundles so that patient demographics, observation data, and clinical outcomes flow directly between Worthmed's system and partner hospital EHRs without translation layers. AWS S3 handles document storage with versioning for audit trails. Role-based access controls and cryptographic audit logging ensure every action is traceable, which is critical for regulatory submissions and quality oversight.

The MVP shipped on schedule with core protocol design, site management, regulatory templates for INFARMED and European standards, and FHIR interoperability. Our approach was hypothesis-driven: we validated each feature with actual hospital workflows before generalising. When Hospital CUF Descobertas onboarded, they brought real protocols. That feedback shaped the next three iterations.

What this shaped

Protocol design time compressed from 12-16 weeks to 6-8 weeks. That's not a process improvement — it's a structural acceleration. Studies that were blocked waiting for approvals now move. Hospital teams have real-time visibility into regulatory readiness instead of chasing status emails. Worthmed's customers — including multiple top European healthcare organisations — are onboarding because the platform works at hospital scale, not startup scale.

The working relationship between Twistag and Worthmed has scaled from initial MVP to ongoing product development, with the team shipping features regularly and pushing back on the roadmap when it drifts from what the market actually needs.

What this proved