Cleverbit built a bespoke Azure platform that automates business continuity management for a leading global CRO, replacing manual spreadsheets with an end to end system for event creation, site notification, and compliant reporting across clinical trial sites. Delivered a month ahead of schedule, the platform is now live.
Eman Zerafa
Chief Technology Officer (CTO)
“I am very pleased with how the project has been executed. The team at Cleverbit has been very professional throughout, and they delivered the project one month ahead of the original scheduled delivery date. The quality of the output has been high and the communication has been excellent.”
THE SITUATION
When disruption hits, the clock starts
Pharmaceutical trial sponsors retain ultimate regulatory accountability for every trial they run, even when day-to-day management is delegated to a contract research organisation (CRO) such as the one in this case study. Under ICH E6(R3) GCP, that accountability does not transfer. When a disruption occurs, trial sponsors need a structured, auditable answer quickly: which sites are affected, are those trials still valid, does enrolment need to pause, and what must be reported
to regulators.
A leading global CRO is one of the world’s largest contract research organisations, managing clinical trials across a global network of sites in every major market. Disruption can force individual sites to pause or stop entirely. A pandemic limiting patient access, a cyberattack hitting site systems, or a natural disaster cutting off a region: each event affects sites differently, and the impact of every one needs to be logged and assessed so the overall effect on the trial is understood. The response has to be fast, structured, and fully auditable, because delays carry regulatory and patient safety implications that go well beyond the operational.
The CRO already had a process. When a disruptive event occurred, teams would manually identify affected sites, send emails to site managers, collect responses through spreadsheets, and try to consolidate the picture from there. It held up for isolated, localised disruptions, but events like the Covid-19 pandemic, which affected trial sites simultaneously across every major market, exposed the limits of the manual approach. It was not built for a global network of this size, and it could not
produce the structured, auditable output that regulators and trial sponsors expect.
THE BRIEF
To automate and digitalise that entire process end-to-end
From the first alert through to resolution: event creation, site identification, structured data collection, notifications, approvals, reporting, and compliance. All in one platform, replacing the spreadsheets and inbox threads with something built for the scale and governance demands of global clinical research.
THE APPROACH
Three decisions shaped the engagement
Analysis before anything else
Before a line of code was written, Cleverbit ran a structured seven-week Analysis Phase with the CRO's Business Continuity stakeholders, Single Service Leads, and IT teams. Five formal workshops, six supporting sessions, and a complete set of deliverables: user stories, architecture diagrams, wireframes, a visual design system, and a Project Definition Document that every stakeholder signed off on. The scope was agreed before delivery began.
A cloud model that simplified everything
During analysis it became clear that depending on the CRO's internal IT infrastructure would introduce delays and integration risk. Cleverbit proposed a dedicated Microsoft Azure environment, hosted and managed entirely by Cleverbit, with the CRO retaining full data and intellectual property ownership. The switch removed infrastructure complexity, kept delivery on track, and had no impact on compliance. The CRO got the data isolation of an on-premise solution without the burden of running it, and owns everything outright.
Formal change governance throughout
Every change during delivery, whether a new feature, an architectural adjustment, or a scope refinement, was documented, estimated, and signed off before implementation. The CRO had full visibility over budget and scope at every stage, and the team had a clear, shared record of how the product evolved.
WHAT WAS BUILT
Five capabilities, one integrated platform
Event management
Business Continuity Administrators (BC Administrators) create and manage disruptive events from a central dashboard. Each event captures the type, affected geography, and severity, and triggers the downstream workflow automatically. Events are logged with full audit trails from creation through to closure
Geographic site selection
The platform pulls live data from the CRO's CTMS and medical imaging platform to identify which trial sites fall within the affected area of each event. BC Administrators can review and adjust the site list before notifications go out, so the picture is always current and accurate.
Dynamic questionnaires
Rather than sending generic emails, the platform issues structured questionnaires tailored to the event type. Site Responders answer directly in the tool. Responses feed into a consolidated view that replaces the manual collation of spreadsheets and gives BC Administrators a real-time picture of impact across all affected sites.
Workflow and notifications
A controlled launch triggers automated notifications to all affected site staff. Role-based workflows route responses through Group BC Administrators for regional review before reaching Central BC Administrators for final assessment and sign-off. Every step is timestamped and logged.
Reporting and compliance
The platform generates structured reports exportable to the CRO's Enterprise Data Warehouse. Every action is captured in an immutable audit trail meeting EMA, ICH E6(R3), and 21 CFR Part 11 requirements. The CRO owns the full intellectual property of the platform.
Technical foundation
The platform runs in a dedicated Microsoft Azure environment, a bespoke cloud instance configured specifically for this workload. Integration with the CRO’s existing CTMS and medical imaging platform means site data flows in automatically, removing manual data entry and keeping the platform current without additional administrative overhead. Delivery followed Cleverbit’s standard AI-assisted Software Development Lifecycle (A-SDLC), applying AI tooling across requirements modelling, code generation, and compliance documentation.
"I am very pleased with how the project has been executed. The team at Cleverbit has been very professional throughout, and they delivered the project one month ahead of the original scheduled delivery date. The quality of the output has been high and the communication has been excellent."
Now in production
The BC Tool has entered live operation. Cleverbit and the CRO will review performance after the first 60 to 90 days of live use. The objectives agreed at the start of the project are the benchmark.
Response speed
Time from event creation to first site notification: the platform is built to compress what previously required manual coordination into minutes.
Reach
Questionnaire completion rates across affected sites at scale, measured against the full population of sites linked to each event.
Workflow efficiency
Time from event launch through to final approval sign-off, across the full role-based workflow.
Data quality
Completeness and accuracy of exports to the CRO's Enterprise Data Warehouse, and integrity of the audit trail for regulatory inspection.
User adoption
Active use across both the BC Administrator and Site Responder roles, across the CRO's global network.
The platform was delivered a full month ahead of schedule. What it does in production is what matters. We will report on that once live data is available.
At the client’s request, their name and identifying details have been withheld.