Clinical Development For CNS And Neurological Diseases
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 3, 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.
Explore Our Recent Neurology Experience
