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.
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.
Understanding the breast cancer patient journey
A biopharma company sought a clear, data‑driven view of the HER2⁺ mBC patient journey to improve forecasting, brand strategy, and medical engagement, lacking a unified perspective.
Triple negative breast cancer
A large, multinational pharmaceutical company needed to better understand patient perspectives to optimize protocol and study design and operationalise a study for TNBC.
Prioritizing efficiency and fit for purpose strategy in digital risk detection
ICON operationalized a hybrid decentralized clinical trial for participants experiencing bothersome Vasomotor Symptoms (VMS).
Driving payer education and awareness
ICON delivered a multifaceted omnichannel awareness campaign to provide a seamless customer experience between print and digital channels for a drug to treat PPD.