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.
Pivotal NDA submission trial in ALS
ICON exceeded recruitment objectives within the initial recruitment timelines during COVID-19 pandemic.
Early phase study for non-opioid pain treatment
A leading biotech company developing a groundbreaking non-opioid treatment for moderate-to-severe acute pain partnered with ICON to conduct a series of early-phase trials.
Overcoming activation and enrollment delays
ICON partnered with a drug development sponsor to conduct a global programme for Multiple sclerosis (MS) studies in over 2,200 patients.
Accelerated auxiliary medicine procurement for MASH trial
A biotechnology company required vitamin D distribution as an auxiliary medication for a phase 3 MASH and fibrosis clinical study. When the original supplement vendor was unable to support the study’s full global scope, the company engaged ICON’s Accelerated Pharmaceutical Solutions (APS) team to step in on short notice.
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High-priority cardiovascular study
ICON was engaged to support phase 2 study in patients with heartfailure and impaired systolic function. ICON’s proactive approach ensured the successful delivery of this complex study and enabled the client to make key strategic program decisions to advance their larger phase 2 trial.
PAC19 VCN ddPCR test
The PAC19 VCN digital droplet (dd)PCR test was validated by ICON to detect and monitor CAR-T (chimeric antigen receptor) cell expansion and persistence in patients receiving anti-CD19 CAR-T therapies.
Combined study with in vitro device investigating an oncology treatment
A study sponsor was investigating a biological treatment for oncology patients in addition to the standard of care chemotherapy. They sought regulatory support from ICON due to the study’s complexity, the geographic span and because the IVD was used out of its intended purpose.
Proactive patient retention strategy in a GLP-1 RA trial
Explore how ICON successfully supported a sponsor’s cardiovascular outcome trial for a GLP-1 receptor agonist with 9,900+ patients with type 2 diabetes and maintained a retention rate of 97% over 7 years.
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Regulatory Strategy in Clinical Development (EU)
"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."
program."
Increased compliance for complex Alzheimer’s disease study
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.
Multinational phase 1 biosimilar 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.
Exceeding recruitment timelines in a double-blind multiple system atrophy (MSA) study
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.