Therapeutics case studies

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.

Global, full-service delivery for complex psychedelic trials

How ICON delivered a multinational psychedelic programme across 12 countries and 150+ sites.

Maximising data capture in obesity trials

A global Phase 2/3 obesity trial leveraged a scalable DXA imaging strategy to overcome equipment limitations and eliminate ‘silent attrition,’ ensuring complete visceral fat data capture across a diverse, multi‑site network.

ADME and ABA trial in solid tumor patients

This phase 1 oncology ADME and ABA study faced strict eligibility, screening, radiolabeled drug logistics, and 72-hour shelf-life constraints, requiring precise coordination, specialised expertise and patient recruitment.

Seamless collaboration on a complex co-sponsored oncology study in three APAC locations

A Europe-based biotech company that had recently gone public sought ICON’s support on a global oncology
study. The study investigated a novel treatment of advanced solid tumours in the head and neck.