A large global pharmaceutical sponsor engaged ICON to stabilise, modernise, and scale Clinical Data Science (CDS) delivery across more than 90 active studies. The engagement required predictable execution, accelerated cycle times, and a unified operating model following vendor consolidation. ICON deployed an outcomes‑led Functional Service Provider (FSP) model spanning Data Management (DM) and Clinical Central Monitoring (CM), underpinned by disciplined governance, multi‑layer quality oversight, and a dual‑hub talent model.

The sponsor faced significant operational pressures during a period of rapid portfolio expansion and modernisation.

• Achieving ambitious corporate KPIs: Faster LPLV‑to‑DBL timelines and stronger lock readiness were essential across diverse therapeutic areas.
• Ensuring consistency at scale: More than 90 concurrent studies required harmonised processes and predictable delivery.
• Managing complexity across multiple data sources: Execution depended on co‑ordination across platforms, vendors, and external providers.
• Scaling resource rapidly and reliably: The model needed to support rapid ramp‑up without compromising oversight.
• Advancing modernised ways of working: The sponsor sought to embed risk‑based approaches, reduce manual effort, and strengthen standardised QC practices.

ICON implemented a structured, outcomes‑driven FSP model designed to increase predictability, elevate quality, and drive modernisation.

• Operating model and governance

Clear lines of accountability, harmonised playbooks, and transparent escalation pathways were supported by weekly operations reviews and real‑time KPI dashboards. ICON’s proprietary INSIGHT platform provided portfolio‑level visibility, surfacing live operational metrics and early risk signals to strengthen decision‑making and ensure consistent delivery performance.

• Multi‑layer quality system

A layered quality framework combined proactive risk identification, independent oversight, and defined performance thresholds. Vigilance 360, dipstick QCs, and database checks ensured sustained inspection readiness.

• Hypercare onboarding

A 30/60/90‑day onboarding model accelerated productivity. Resources typically reached independent performance by day 60 and stabilised by day 90.

• Functional management model

ICON provided active oversight of workload, quality, and task progress. Portfolio leads monitored KPIs, capacity, risks, and issue closure.

• Embedded innovation

Automation initiatives, refined process maps, and a standard library reduced variation. Six improvement streams delivered more than 30 workshops annually to accelerate modernisation.

ICON delivered measurable gains in quality, speed, and predictability across the sponsor’s global portfolio.

• LPLV‑to‑DBL reduced from around 28 days to 21 days, progressing toward a 14‑day target.
• Database freezes achieved 25% faster across comparable studies.
• More than 95% of DMCs, DBLs, and IAs delivered on time.
• Error rates reached 0.12% (queries) and 0.02% (listings).
• Zero data‑management‑related unlocks and zero major audit findings.
• Escalations reduced by approximately 75% year‑over‑year.
• Sponsor reported around 30% cost savings and 20–40% KPI improvement.

• Outcomes‑led delivery aligned to KPIs and cycle‑time targets.
• Shared, cross‑trained talent pools enabling rapid scale‑up and reliable continuity.
• Centralised shared services reducing duplication and accelerating onboarding.
• Standardised processes and playbooks minimising variation and strengthening consistency.
• Continuous improvement and automation enhancing efficiency and operational maturity.

Together, these capabilities created a streamlined, high‑performing FSP model offering measurable efficiency, predictable quality, and enduring support for the sponsor’s R&D modernisation and long‑term data strategy.

Partner with ICON to enhance data integrity, operational resilience, and oversight across your studies. 

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