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Case Studies

Representative outcomes from clinical safety governance and trial technology engagements. Client details are anonymised.

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Clinical Operations

Series B Cell Therapy Company

Consolidated trial systems and reduced reconciliation burden

Context

A Series B cell therapy company with 3 active trials across Phase 1 and 2, using separate vendors for EDC, RTSM, and safety systems.

Challenge

Fragmented vendor landscape created delays, duplicate workflows, and weak visibility across trial operations. Data reconciliation between systems consumed 20+ hours per week, and site staff struggled with multiple logins and inconsistent interfaces.

Approach

Conducted a comprehensive architecture audit, selected a unified platform strategy, and designed a staged migration plan across active studies. Prioritised data model alignment and phased vendor transition to minimise disruption.

Outcome

Reduced data reconciliation cycle time by 60%, eliminated two redundant vendor contracts saving $180K annually, and improved site staff satisfaction scores by 40%.

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