Real-world data/evidence case studies
Learn more about our expertise
Learn more about our work from our library of real-world evidence/data case studies and explore our in-depth scientific expertise across disciplines.
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.
Optimising a fully decentralised Alzheimer’s study through Digital Risk Detection
ICON operationalised a fully decentralised clinical trial for a midsized pharmaceutical company running a proof of concept to evaluate self-directed scalable electronic health platform methods for communicating Alzheimer’s Disease (AD) gene and biomarker results.
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.
Transitioning from a Phase 3 study to an EAP
This case study highlights the strategic execution of an Expanded Access Program (EAP) across multiple global regions, Europe, Asia-Pacific, and Latin America, following a Phase 3 clinical study.
Rapid deployment of a compassionate use program
During the peak of the COVID-19 pandemic, a global compassionate use program (CUP) was urgently needed to provide compassionate use of a promising treatment. The program required rapid deployment across multiple regions to support hospitalized patients.
Consolidation of multiple protocols into a single LTE oncology study
To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required.
Integration of multiple oncology studies into a single OLE study
An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study.
From early engagement to award
An established customer sought to streamline patient follow-up across multiple clinical protocols, each involving different sponsors and assets, to support ongoing treatment and safety data collection.