Therapeutics case studies

ICON conducted a multi-centre study to assess the efficacy, safety, and tolerability of an anti-α-synuclein human immunoglobulin G1 monoclonal antibody in patients with Multiple System Atrophy followed by an open label extension.

A digital health lead at a large pharmaceutical company came to ICON Outcome Measures to find a wearable that could capture continuous cardiac rhythms and be used to detect QT prolongation.

ICON partnered with a biotech sponsor to optimise Case Report Forms (CRFs) for an oncology cell and gene therapy trial. By adopting iRECIST criteria and standardising CRF templates, we reduced data duplication, ensured accuracy, and provided flexibility for subject re-treatment.

A complex oncology study in multiple myeloma cancer experienced a 30% higher than anticipated enrollment rate, leading to a large data backlog. Learn how ICON implemented global remote monitoring to address the backlog and manage ongoing data volume.

This case study explores two Bayesian model-assisted designs in the context of early phase oncology clinical trials, focusing on their application and impact on study design. It includes a review of each design’s operating characteristics, proposed amendments, and simulations.

As a result of the multifaceted communication approach with sites and a strong partnership between ICON and sponsor, the study met its protocol-specified enrolment goal just 9 days beyond contracted Last Patient In date (LPI).

ICON delivered a multifaceted omnichannel awareness campaign to provide a seamless customer experience between print and digital channels for a drug to treat PPD.

Through close collaboration with a client, the ICON team provided the support necessary to advance a critical COVID-19 manuscript from outline through submission to acceptance in only 20 days.

ICON developed the first PKU-specific Quality of Life questionnaire available and validated in four age groups and seven languages.

ICON supported a randomised phase 3 study to examine the study drug in combination with nivolumab vs chemotherapy in patients with checkpoint inhibitor refractory non-squamous NSCLC.

ICON was selected by a mid-size biotech company to support a phase 1 dose escalation and cohort expansion study of an immune checkpoint inhibitor, in patients with advanced solid tumors. Mid-study, the sponsor was acquired by a large pharma company to which ICON has efficiently supported the transition to the evolving sponsor business model and operations.

A pharmaceutical client needed to better understand patient perspectives, concerns and awareness of that could impact the development of a vaccine for Human Cytomegalovirus (HCMV).