Therapeutic Areas
Clinical Development for CNS and Neurological Diseases
Driving successful outcomes for CNS and Neurology trials is challenging
Second, only to Oncology, CNS, and Neurology clinical trials are incredibly complex and complicated to navigate. CNS trials are plagued with high failure rates at or before phase III, and therefore require careful risk mitigation throughout trial design and execution with close regulatory agency collaboration. That is why Veristat has built a team of scientific-minded experts who have supported more than 250 CNS/Neurology projects, including drug, biologic, and diagnostic trials. More than 35% of these treatments are for rare or ultra-rare neurological diseases or disorders.
Driving CNS and Neurology Treatments to Approval
Our diverse trial experience, coupled with our knowledgeable and experienced teams, allows us to confidently handle the most complex trials and patient populations with the attention and focus needed to navigate the neurological disease landscape.
At Veristat, our experienced teams are poised to plan and implement these efforts quickly providing:
- Development of regulatory strategy, expedited pathways, and regulatory agency interactions
- Clinical program planning, inclusive of statistical planning and analysis
- Agile patient recruitment strategies to support virtual trial and hybrid approaches
- Rapid deployment of clinical trial databases
- Virtual and remote clinical and medical site monitoring
- Data analysis and migration into CDISC formats
- Writing of clinical trial, safety, and regulatory documents
- Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.
|
|
|---|---|
250+project supported for CNS/Neurology Disorders |
|
35%clinical trials are rare disorders |
|
20%clinical trials are genetic neurological disorders |
|
Explore Our Recent Neurology Experience
Neurology Indications |
||
|---|---|---|
| Adrenoleukodystrophy | Epilepsy | Pain & Inflammation |
| Alzheimer's Disease | Friedreich's Ataxia | Parkinson's Disease |
| Amyotrophic lateral sclerosis (ALS) | Genetic Abnormalities | Pompe Disease |
| Attention Deficit Disorder (ADD) | Hearing Loss | Post-Operative Pain |
| Attention Deficit/Hyperactivity Disorder (ADHD) | Insomnia | Sanfilippo Syndrome |
| Autism Spectrum Disorder | Limb Girdle Muscular Dystrophy Type 2i (LGMD2i) | Schizophrenia |
| Canavan Disease | Lumbar Radiculopathy | Sjogren-Larsson Syndrome (SLS) |
| Cerebral Adrenoleukodystrophy (CALD) | Maroteaux-Lamy Syndrome | Sleep Apnea/ Sleep Dysfunction |
| Depression | Migraine | Stroke |
| Diabetic Neuropathy Pain | Multiple Sclerosis (MS) | Spasticity Due to Spinal Cord Injury |
| Dravet Syndrome | Nocturnal Foot and/or Leg Cramps | Spinocerebellar Ataxia (SCA) |
| Duchenne Muscular Dystrophy | Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) | Tardive Syskinesia |
Infographic
Marketing Applications Approval Record
Webinar Presentation
Future Trends on European Regulations on Medicines
Case Study
The Power of Publishing for an Efficient NDA Submission ...