Experience

Solutions

Central Nervous System (CNS) Disorders

Pharmaceutical companies developing new CNS products face special obstacles.  PAREXEL has global in-depth expertise in neurology, psychiatry, and neuroimaging that can provide strategic and practical support to simplify and accelerate your product development. We have recent experience in hundreds of studies involving several thousand patients. Specific indications include, but are not limited to, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, epilepsy, stroke, pain management, sleep disorders, ADD/ADHD, neuropathic pain, schizophrenia, bipolar disorder, depression, addiction, and anxiety.  With our experience and expertise, we have the ability to provide proactive solutions to potential clinical trial issues. 

Specific strengths of our Central Nervous System (CNS) experts include:

• Strategic insight into design and development of CNS trials. We have expertise incorporating use of state-of-the-art biomarkers and other approaches from our CNS ToolKit, diagnostic adjudication approaches to ensure randomization of appropriate patients into studies, and enhanced signal detection strategies to improve clinical trials sensitivity to drug, while reducing sample size.
• Seamless, end-to-end support of CNS drug development, from hospital-based First in Human studies to Proof of Concept, Phase III, and post-marketing study commitments. We use “learn and confirm” approaches with the same team members to ensure continuity across all phases of development.
• Demonstrated ability to manage complex central nervous system (CNS) trials in Phase I-IV in every region — North America, Latin America, Europe, Asia, and Australia.
• Extensive experience with medical feasibility studies, providing critical data about regions, countries, sites, investigators, standards/quality of care, and competing trials.
• Active engagement in medical education and ongoing clinical care of patients.
• Major commitment to internal CNS training for PAREXEL staff.
• Experience in academic medicine, hospital-based clinical practice, and clinical and laboratory research investigations.

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