Case studies
Working with our customers to reduce time to market, deliver on quality, provide deep therapeutic expertise, and enhance R&D ROI.
Highlights
We focus our innovation on the factors that matter most — accelerating time to market, reducing costs and enhancing quality. Learn more about how we've helped clients meet and exceed their goals in this selected library of case studies.
Proactive patient retention strategy in a GLP-1 RA trial
Explore how ICON successfully supported a sponsor’s cardiovascular outcome trial for a GLP-1 receptor agonist with 9,900+ patients with type 2 diabetes and maintained a retention rate of 97% over 7 years.
A small biotech success story
A small US-based biotech company was in a race to be the first to market with their lead targeted oncology product.
FSP partnership - sustained efficiency and ongoing innovation
The implementation of an FSP model across our partner's project management function, led to 20% cost efficiences and a 30% reduction in client burden.
By taking a site and patient-centric approach, and leveraging advanced tools and real-time data insights, we maximise patient access, recruitment, and retention—ensuring that every trial is conducted with efficiency, agility, and a commitment to improving patient outcomes.
All case studies
Select amongst our broad range of solutions and experience.
Pregnancy registry study with direct-to-participant and HCP data collection
Generating pregnancy safety evidence for rare disease therapies presents unique challenges, including extremely low exposure rates and geographically dispersed patient populations.
Descriptive Pregnancy Safety Study (DPSS) using PRIM model
To support post-marketing safety commitments, ICON implements the Pregnancy Outcome Intensive Monitoring (PRIM) approach, whereby data on exposed pregnancies are collected through enhanced pharmacovigilance processes.
Delivering pregnancy exposure evidence through a hybrid global model
Global pregnancy safety programs require flexible evidence-generation strategies that can adapt to regional regulatory requirements, operational constraints, and differences in expected pregnancy exposures across markets. ICON designed and implemented a hybrid pregnancy safety study combining a decentralised US pregnancy registry with a Pregnancy Outcome Intensive Monitoring (PRIM) approach across the rest of the world.
From Shanghai to Singapore: Strategic insights enable a biotech’s APAC expansion
The HSA operates reliance-based evaluation routes for products approved by recognised reference agencies, such as the FDA, EMA, TGA, Swissmedic, Health Canada, and MHRA. However, China’s NMPA is not currently among HSA’s reference agencies
Coordinating successful multi-regional inspections by FDA, PMDA and TFDA
The sponsor, an established biotech company with expertise in antibody drug conjugate development (ADC),
partnered with ICON in 2020 for support with a phase 3 clinical trial. ICON provided clinical operation and regional
oversight supports for the Asia Pacific (APAC) and Latin America (LATAM) regions.
partnered with ICON in 2020 for support with a phase 3 clinical trial. ICON provided clinical operation and regional
oversight supports for the Asia Pacific (APAC) and Latin America (LATAM) regions.
Accelerated enrolment in a lactation study
ICON exceeded enrolment expectations in a competitive lactation research environment, completing enrolment more than twice as fast as planned while achieving 100% participant completion through a convenient, participant-centric study design.
Proactive problem-solving preserves data integrity in lactation study
ICON rapidly resolved a critical sample stability issue, preserving data integrity while enrolling 8 participants and achieving 100% completion.
Lactation study of an FcRn inhibitor
ICON's targeted recruitment strategy accelerated enrolment, minimised screen failures, achieved 100% completion, and ensured timely study delivery.
Lactation study for two CGRP receptor therapies
ICON overcame complex recruitment barriers through targeted outreach and flexible scheduling, achieving full enrolment, 100% retention, and on-time delivery.
Complex oral semaglutide lactation study
Rapid recruitment and participant-focused support enabled ICON to restore study momentum, reduce risk, and achieve full completion in this rescue study.
Delivering high quality data in a complex heart failure trial
CardioResearch and ICON partnered to deliver a complex phase 1b–2a heart failure trial through collaborative expertise, governance, and innovative operational execution.
Solving complexity in early clinical imaging
ICON partnered with the University Medical Center Groningen to deliver a complex crossover study with 240 brain MRIs in 60 participants, delivering fast, consistent data and a seamless experience.
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