Central Nervous System

Clinical understanding of neurobiology is incomplete, contributing to central nervous system (CNS) clinical development programmes having among the highest failure rates across all therapeutic areas. CNS clinical trials bring specific challenges, including managing placebo response, incorporating soft endpoints, and require a particular focus on reducing patient burden.

Unsurprisingly this had led to a challenging of accepted and established norms by CNS drug developers.

We support sponsors in minimising development risk and maximising probability of success through:

• Access to the latest, applied technology innovation and processes
• Working with our highly qualified and therapeutically trained staff
• Real time data quality monitoring and analysis

Services for CNS, Pain and Ageing Diseases

Our Protocol Optimisation and Clinical Development Plans service is complemented with Adaptive Design competency and regulatory approved software. Our full-service study/program implementation and execution include: 

• Bioanalytical laboratories to support the development and analysis of biomarker assays in the neurodegenerative disease space
• Medical Imaging including neuroimaging, such as positron emission tomography and functional- or pharmaco-MRI
• Access to our global KOL expert and CNS site network including our Early Development Services (EDS) group  which has extensive experience in neuroactive drug development including 160+ Phase I and Phase IIa clinical studies with neuroactive agents.
• (Electronic) Clinical Outcomes Assessment and digital endpoints expertise
• Access to biobanks and patient registries
• Advice on use and implementation of innovative wearable technologies

Dedicated specialist teams

All staff assigned to projects, including project management, drug development, site identification, feasibility, and medical oversight attend customised training programs. Over the past five years, ICON have conducted phase I, II & III studies in various CNS indications. We also offer dedicated teams for rare and paediatric CNS programs.