Therapeutics case studies

"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."

The sponsor in this case was a large pharmaceutical company that contracted ICON to manage and streamline the training and compliance workload for their phase 2 Alzheimer’s study.

ICON conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.

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.

ICON operationalized a hybrid decentralized clinical trial for participants experiencing bothersome Vasomotor Symptoms (VMS).

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.

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.