Cleverbit built a bespoke Azure platform that automates business continuity management for ICON, 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) like ICON. When a disruption occurs, trial sponsors need a structured, auditable answer quickly: which sites are affected, can clinical research still be conducted, does enrolment need to pause, is resupply affected, and what must be reported to their clients.
ICON 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 everyone needs to be logged and assessed so the overall effect on the trial is understood. The response must be fast, structured, and fully auditable, because delays carry regulatory and patient safety implications that go well beyond the operational.
Previously ICON had a purely manual process. When a disruptive event occurred, a time-consuming site selection process was conducted, follow-ups were mainly organised by email and feedback was consolidated in spreadsheets. It held up for isolated, localised disruptions, but events like the Covid-19 pandemic, which affected trial sites simultaneously globally, exposed the limits of the manual approach. There was a clear need to build a solution that is flexible and scalable to meet the demands of all types and sizes of disruptive events.
The brief was to automate and formalise that entire process into a system-supported solution, end to end. From the first alert through to resolution: event creation, site and responder identification, structured data collection, notifications, delegation, 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
During analysis it became clear that depending on ICON's internal IT infrastructure would introduce delays and integration risk. Cleverbit proposed a dedicated Microsoft Azure environment, hosted and managed entirely by Cleverbit, with ICON retaining full data and intellectual property ownership. The switch removed infrastructure complexity, kept delivery on track, and had no impact on compliance. ICON got the data isolation of an on-premises solution without the burden of running it, and owns everything outright.
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. ICON 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 triggers the downstream workflow automatically. Events are logged with full audit trails from creation through to closure.
Geographic site selection
The platform uses data from ICON's existing databases to display site geolocation’s that assist with selecting trial sites that fall within the affected area of each event. BC Administrators can review and adjust the site list based on other attributes, before notifications go out, so the picture is always current and accurate.
Dynamic questionnaires
Rather than sending generic emails, the platform offers a questionnaire library and issues structured prebuilt questionnaires tailored to the event type. Responders answer directly in the tool or delegate completion to team members. 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.
WHAT WAS BUILT
Built for compliance from the ground up
Workflow and notifications
A controlled launch triggers automated notifications to all Project Managers or Functional Leads of affected sites. Role-based workflows route responses through Group BC Administrators for regional review before reaching Central BC Administrators for reporting to senior management. Every step is timestamped and logged.
Reporting and compliance
The platform generates structured reports exportable to ICON's Enterprise Data Warehouse or for visualisation using Business Intelligence Solutions. Every action is captured in an immutable audit trail meeting legal requirement. ICON 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 ICON’s existing systems 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 Framework (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."
WHAT COMES NEXT
Now in production
The BC Tool has entered live operation. Cleverbit and ICON 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.