Neuroscience

Maximize your trial’s impact with continuous quality control

Enormous advances in the understanding of how the brain works and development of treatment modalities are cause for great hope for millions of people affected by neurological disorders. As a CRO, Parexel is at the forefront of clinical research in neuroscience where much of the work of accelerating breakthroughs actually happens. Working with biotech and large enterprises worldwide, with a division dedicated to emerging companies, we cover all indications across neurology and psychiatry with a laser focus on operational excellence. Executing trials with precision and impeccable quality is fundamental to bringing new therapies to those who urgently need them.


 

Achieve your goals with our full-coverage neuroscience practice

Neuroscience trials require close collaboration between our team, your team, and trial sites to deliver on your goals. Our team brings dedication and passion to that collaboration, with deep experience and personal commitment that drives flawless execution. We assign resources with experience in the specific indication to every project. Close adherence to the strategic plan, the flexibility to adapt, continuous communications, and proactive problem resolution are key elements to controlling timelines and budget. Underpinning these capabilities are the technology tools embedded in our practice that enable early detection, trial monitoring, risk mitigation, and support for physicians (raters) who run assessments during the trial. We design and deliver studies that ensure patient safety, data integrity, regulatory compliance, and scientific rigor.

For our customers focused on advancing the science and developing treatments, we amplify their work with real-world alliances and established relationships with sites, investigators, and patients worldwide. There is no substitute for the breadth of our reach and the depth of our expertise as a large CRO.

Read the transcript

I'm very proud of my team. To see the talents, the expertise, medical directors with diverse backgrounds, different experience in academia, clinical practice, the industry all over the around the world, experts in different neurology and psychiatry indications they know clinical development very, very well. They are doing it for the patients and we are all patients at some point. So that's very important.

We are entering a new era when it comes to neuroscience. We've seen that with recent approvals of treatments in indications where for many years we were facing failures and disappointments. Scientists through research, hard work, efforts, understand better today the mechanisms of some of the diseases and therefore they find good ways to address the problem. So I think that's one important part of why neuroscience is very exciting nowadays.

The other is the patient's voice. Patients today are important stakeholders around the table. They are decision makers. They influence research, they influence the pathway of approvals and access to treatment. I think this is extremely important. But we have still some distance to cover, so we want them to be more active. We want them to be real partners because these are treatments for them.

Another point is that we're entering this era of addressing how to repair the damage and also how to discover diseases very early. So early diagnostics, the role of biomarkers and how to move towards precision medicine and prevention are really very important questions for neuroscience, because for many of these diseases, the moment that somebody gets symptoms equals many of the cells that are affected are already gone, so it's too late.

So we need to address this important need of discovering diseases early. Examining the general population and also maybe being more preventive than treating the disease when it's too late. When I think neuroscience at Parexel, I know that we are the reference for sponsors for difficult problems to solve. Alzheimer's, Parkinson's, multiple sclerosis, depression. These are key priorities for the world because there are great unmet needs there.

Experience in the past 5 years with neuroscience

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clinical and consulting projects
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enrolled patients
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active unique sites
Indications

Psychiatry

Psychiatry focuses on diseases characterized by alterations in mood, behavior, cognition and perception — like schizophrenia, major depressive disorder, bipolar disorder, anxiety disorders, and post-traumatic stress disorder. Our experience includes the use of novel treatments targeting important unmet medical needs, such as negative and cognitive symptoms in schizophrenia, treatment-resistant depression, and studies in both acutely ill and stable patient populations.

Our board-certified psychiatrists, in collaboration with biostatisticians and regulatory experts, are always ready to engage in study design optimization, methods to reduce placebo effect, and clinical development strategy. We also improve the interpretability of results by focusing on rater training, instream monitoring of data quality and study conduct, and risk mitigation strategies.

Mohit Verma, M.D.

Global TA Section Head, Psychiatry

Marija Grunauer, M.D.

Medical Director

Maeve O’Gorman

Senior Project Leader

Octavian Alexe

Clinical Operations Leader

Neurology

Neurology focuses on the diagnosis and treatment of diseases and disorders of the nervous system, which includes the brain, spinal cord, peripheral nerves, and muscles. Our experience includes a wide range of neurological conditions, such as epilepsy, Alzheimer's disease, Parkinson's disease, traumatic brain injury, and others.

Parexel's approach to neurology research combines scientific rigor, collaboration, patient-centricity, advanced technologies, and global reach to drive innovation and accelerate the development of breakthrough therapies for neurological disorders.

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Advantages

Trial designs for any indication

Our expertise in study design includes pediatric and adult, common and rare disease, shorter-term studies to evaluate symptomatic treatments, and longer-term studies to assess for disease modification. We bring expertise in adaptive designs, the use of external control arms, and the use of real-world evidence. We’re also well versed in state-of-the-art biomarkers, diagnostic adjudication, and signal detection strategies.


Seamless support across neuroscience drug development

We’ll provide support for any stage of your project, from hospital-based first-in-human studies to proof of concept; from dose-finding to Phase III confirmatory studies; and from long-term safety and post-marketing study commitments, to indication expansion. We have the experience and expertise to drive your research forward.


Extensive psychiatric & neurological capabilities

Our psychiatry and neurology clinical expertise includes capabilities like the continuous collection of cerebrospinal fluid for sampling, neuropsychological testing, and evaluation, and use of biomarkers and imaging for diagnosis and outcomes. We also offer comprehensive neuropsychological evaluations across the spectrum of cognitive aging.

Highlights


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