Therapeutics case studies
How we maximise the value of our clients' development approach while reducing costs and timelines
Learn more on how we bring life changing therapies to market.
Providing empirically based guidance and built-to-spec models and solutions across every phase of clinical research and lifecycle management for therapeutic development.
Navigating biometrics complexity in a pivotal CAR T-cell therapy submission
This case study demonstrates how ICON’s specialist biometrics expertise supported a complex pivotal CAR T-cell trial, delivering robust safety and efficacy analyses and regulatory-ready support for submissions to the FDA and European Medicines Agency.
Exceeding enrolment and mitigating placebo response for better outcomes in Major Depressive Disorder trials
ICON partnered with a sponsor to deliver a 14-week multicentre double blind randomised placebo-controlled phase
2 study in Major Depressive Disorder (MDD). The study assessed a fixed dose of an innovative oral compound in 8
countries across 53 sites with 338 participants enrolled against a target of 324.
2 study in Major Depressive Disorder (MDD). The study assessed a fixed dose of an innovative oral compound in 8
countries across 53 sites with 338 participants enrolled against a target of 324.
Multilingual global label monitoring for late-stage oncology
By combining global labelling expertise, translation capabilities and adaptable document comparison workflows,
ICON delivered a reliable monitoring program that identified 100 label changes across 500 labels in four languages.
ICON delivered a reliable monitoring program that identified 100 label changes across 500 labels in four languages.
.jpg?crop=yes&w=1110&h=584&a=0,47&itok=5Gqrpzh3 "case study"){kind=icon}
Rapidly mobilised global labelling review supports oncology portfolio expansion
ICON Global Regulatory delivered a comprehensive label assessments and action plans, ensuring alignment between health authority, core, and local labelling requirements, resulting in a compliant global product portfolio and a contract extension for a second product.
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
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.
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.