Clinical Neurosciences (CNS)

Exceptional medical expertise, with diverse backgrounds in academia and industry

Endpoints in CNS trials can be influenced by many factors, especially those such as placebo effects, investigator biases and patient expectations. Continuous quality control is a critical element of medical and safety support. We know all endpoints must be protected to ensure that the patient’s contribution truly adds value.

Parexel’s CNS practice encompasses four specialty areas (psychiatry, neuromodulation, neurodegeneration/neuroinflammation and rare neurological diseases), each with novel developments underway that hold great promise for treating disease. Conducting clinical trials for these conditions demands close collaboration with sites, especially for staff qualification and training, patient selection, eligibility decisions and instream monitoring of data quality and study conduct. We also work with sponsors collaboratively to consider novel designs, points of potential acceleration and areas of risk.

Our CNS practice is distinguished by:
  • Expert medical team (clinical neurologists, psychiatrists, doctoral-level psychologists, neuropsychologists and neuroscientists) with strong understanding of the scientific developments emerging in clinical neurosciences, experienced in complex CNS clinical trials in Early Phase to Phase IV in every region – North America, Latin America, Europe, Asia and Australia.
  • Regulatory expertise in functional, cognitive and behavioral endpoints for use in CNS-related trials with different populations and indications.
  • Expertise in study design including: pediatric and adult; common and rare disease; shorter-term studies to evaluate symptomatic treatments; longer-term studies to assess for disease modification; adaptive designs; the use of external control arms; and the use of real-world evidence.
  • Experience incorporating state-of-the-art biomarkers and diagnostic adjudication approaches to ensure randomization of appropriate patients, and enhanced signal detection strategies to improve detection of drug/placebo differences.
  • Seamless, end-to-end support of CNS drug development, 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.
  • Study feasibility experts who provide detailed critical data about regions, countries, sites, investigators, standards/quality of care and competing trials to provide accuracy in site selection, recruitment rates and timelines.
  • Access to patient populations with neurological and psychiatric conditions.
  •  Dedicated Early Phase Clinical Research Units
    • Substantial psychiatry and neurology clinical expertise, including capabilities such as continuous collection of cerebrospinal fluid for sampling, neuropsychological testing, and evaluation, and use of biomarkers and imaging for diagnosis and outcomes.
    • Comprehensive neuropsychological evaluations across the spectrum of cognitive aging.

Over the last 5 years, Parexel's CNS experience has included:
 

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Specialties

At Parexel, Clinical Neurosciences is grouped among the four categories. Although there are commonalities among these, there are distinctions based on target types, therapeutic approaches, and study design.

Psychiatry

Psychiatry focuses on diseases characterized by alterations in mood, behavior, cognition and perceptions. Important diseases include schizophrenia, major depressive ...

Psychiatry focuses on diseases characterized by alterations in mood, behavior, cognition and perceptions. Important diseases include schizophrenia, major depressive disorder, bipolar disorder, anxiety disorders and post-traumatic stress disorder. Parexel’s experience includes the use of novel treatments that target substantial unmet medical need, such as negative and cognitive symptoms in schizophrenia and treatment-resistant depression, and conducting 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. Parexel understands the importance of rater training, instream monitoring of data quality and study conduct, and risk mitigation strategies to ensure interpretable study results.

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Rare Neurological Diseases

Of the approximately 7,000 rare diseases leading to significant morbidity, one in three has a neurologic component. Parexel combines our ...

Of the approximately 7,000 rare diseases leading to significant morbidity, one in three has a neurologic component. Parexel combines our neurological expertise with rare disease operational/recruitment excellence, regulatory consulting, cell and gene therapy practice, biomarker strategies, and innovative trial designs, realizing that every patient’s contributions are invaluable. Although the list of diseases is long, Parexel has substantial expertise in Duchenne Muscular Dystrophy (DMD), Amyotrophic Lateral Sclerosis (ALS), Huntington’s Disease, Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), to list just a few. This broad experience provides a basis for flexibly collaborating with sponsors on novel, less well-studied indications.

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Neuromodulation

Neuromodulation focuses on neurological disorders associated with changes in neuronal excitation, inhibition and signalling. These include epilepsy, pain, ...

Neuromodulation focuses on neurological disorders associated with changes in neuronal excitation, inhibition and signalling. These include epilepsy, pain, migraine, and peripheral neuropathies. In addition to traditional pharmaceutical approaches to treatment (e.g., small molecules, monoclonal antibodies), devices that provide neuronal stimulation are becoming important options in the treatment of neurological and psychiatric disorders. Parexel experts collaborate with sponsors to ensure quality delivery of study endpoints, including the use of digital biomarkers and wearable devices to provide continuous, objective data measurements. Parexel understands the need to have strong patient and investigator training, coupled with ongoing data-quality monitoring, for scales that capture subjective experiences like pain.

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Neurodegeneration/ Neuroinflammation

Illnesses characterized by the progressive loss of neurons, such as Alzheimer’s Disease and Parkinson’s ...

Illnesses characterized by the progressive loss of neurons, such as Alzheimer’s Disease and Parkinson’s Disease, are associated with substantial individual, caregiver, and societal costs. Except for Multiple Sclerosis, existing treatments target symptoms without being disease modifying. Emerging treatments to better target pathological conformations of proteins or to affect the brain’s innate responses to pathology offer promise for millions of patients. Parexel has strong expertise in identification of patients early in disease, designing studies to demonstrate evidence of disease modification, and employing adaptive design techniques to accelerate programs and optimize trial outcomes. Our translational medicine group provides expert advice for biomarker strategies and experimental medicine study designs that provide early evidence of target engagement and efficacy.

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