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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

Mid-Size Oncology Sponsor

Accelerated to first patient in 4 months using the FAST execution model

Context

A mid-size oncology sponsor preparing for a pivotal Phase 3 trial with 150 sites across 12 countries, facing tight financing and regulatory milestones.

Challenge

Standard implementation timeline of 14 months threatened key financing and regulatory milestones. The company needed first patient first visit (FPFV) within 6 months to secure Series C funding.

Approach

Applied the FAST (Framework for Accelerated Study Setup and Timeline) execution model with phased governance, prioritised core workflows, and aligned clinical and technology owners in a single operating cadence. Used template-based study setup and parallel workstreams.

Outcome

Completed core deployment in 4 months versus a typical 14-month rollout, achieved FPFV 2 months ahead of schedule, and secured Series C funding at a 30% higher valuation.

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