Neurology and CNS Clinical Development

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 150 clinical trials, including drug, biologic, and diagnostic trials. More than 40% of these treatments are for rare neurological diseases or disorders. 

Driving a Broad Spectrum of Neurological Disorder 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 landscape.

At Veristat, our experienced teams are poised to plan and implement these efforts quickly providing:     

  • Development of regulatory strategy and agency communications 
  • Program Planning, inclusive of statistical planning and analysis 
  • Agile patient recruitment 
  • Rapid deployment of clinical trial databases  
  • Virtual and remote clinical and medical monitoring 
  • Data analysis, migration, and writing of regulatory documents 
CNS Trials and Neurology Trial Planning

Explore Our Recent Neurology Experience

Our expertise in  neurology covers a broad range of movement and mood disorders including:

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Learn More with These Resources

Case Study
Overcoming an NDA Refusal To File

Learn how the right biostatistical experts performed a quality review of the clinical data for an NDA that received a Refusal-to-File from the FDA.

Case Study
Stem Cell Therapy for Stroke Patients

A client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in patients following an ischemic stroke. The goal was to look at limb ...

Fact Sheet
Regulatory Consulting Fact Sheet

Regulatory planning for your clinical development program starts before and continues after you begin preparing your Investigational New Drug (IND) application. As ...

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