Providing sponsors with innovative processes including protocol design, site training, and real-time data quality analysis
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
ICON's experienced neuroscience and drug development teams work across all areas of CNS research including:
- Alzheimer’s Disease
- Amyotrophic Lateral Sclerosis
- Diabetic Peripheral Neuropathy
- Multiple Sclerosis
- Parkinson’s Disease
Acute and Chronic Pain
- Inflammatory / soft tissue injuries
- Low back pain
- Migraine pain
- Neuropathic pain
- Rheumatoid and osteoarthritis pain
- Depressive disorders
- Biopolar disorder
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.
CNS, pain and ageing related disorders insights
ICON's experienced neuroscience and drug development teams regularly share their insights in industry publications and through ICON produced content in the form of blogs and whitepapers. Read more content from our experts.Read more