ICON plc services

Accelerating study start-up and delivering results with custom strategies and logistics solutions. ICON helps navigate the Cell and Gene Therapy journey by overcoming challenges and mitigating risks. Almost every cell and gene therapy clinical trial is novel in some way. Working with living therapies presents new and unique challenges to the traditional clinical trial model. With over 400 dedicated CGT professionals globally, ICON has developed tools and best practices to transform CGT trial design and execution, including an internal `Cell & Gene Therapy Academy` for training ICON staff. From site selection to study startup through execution, ICON provides project management, clinical services, product-specific logistics solutions, data flow, regulatory strategy and central laboratory services.

ICON`s cardiovascular trial experience, supported by a global team of experts. ICON has extensive experience in cardiovascular clinical research trials across the entire drug development spectrum. There is still significant unmet need within select cardiovascular/metabolic (CVM) disorders. Unfortunately, the cost of developing drugs and devices in this area has been rising steadily. ICON, a full service provider, takes a data-driven approach to developing strategies that will cut timelines and costs from First-in-Human (FIH) studies through post approval. We have over 25 years of experience conducting cardiovascular trials, with particular emphasis on key cardiovascular/metabolic indications: heart failure, lipid disorders, diabetes, renal insufficiency and renal transplant, arrhythmia, and rare diseases.

Focused on the unique needs of device and diagnostics manufacturers, ICON has broad experience in supporting trials of respiratory disease and infectious disease affecting respiratory function. The prevalence of respiratory diseases will continue to rise as our global population ages and the incidence of chronic diseases, such as COPD and asthma, increases exponentially. ICON has considerable experience in supporting trials of respiratory disease, infectious disease affecting respiratory function, and supporting investigational treatments in the biotech, pharmaceutical, medical device and diagnostic industries.

ICON has experience with a range of bio-engineered and tissue-engineered products. We help clients to meet clinical, compliance and FDA CDRH, CBER and international regulatory requirements.

ICON works with clients to meet your trial needs in blood banking. We can help you with clinical, compliance and FDA CDRH, CBER and international regulatory requirements for blood banking / blood collection related products and accessories.