For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
Endpoints in neuroscience trials can be influenced by many factors, including placebo effects, investigator biases, and patient expectations. We use continuous quality control, grounded in extensive global medical expertise, to maximize every patient’s contributions across the development journey, from Early Phase to Phase IV trials.
Neuroscience trials require close collaboration, between us, your team, and trial sites to meet your goals. Our team of board-certified neurologists and psychiatrists, global regulatory consultants, and experienced clinical research associates work closely with sites to improve staff qualification and training, patient selection, eligibility decisions, and instream monitoring of study conduct and data quality. At the same time, we work closely with you to develop novel designs, identify potential points of acceleration, and identify risks. The result? Refined, efficient trials.
Our experts in neuroscience
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.
Dementia: by focusing on disease biomarkers and meaningful outcomes for people living with Alzheimer’s disease and their caregivers, we apply our experience in new study designs, eCOA, raters’ training and patient centric approaches and leverage our global site network to deliver with excellency trials of all phases.
Movement disorders: we have successfully run all phases trials in all indications, including Parkinson’s and Huntington’s disease with our expertise expanding to cell and gene therapies and use of sensors as digital biomarkers.
Epilepsy: one of neuroscience’s strongest areas at Parexel with proven expertise working with biotech and enterprise and bringing Phase I assets to registration.
Neuroimmunology/Multiple Sclerosis: in addition to our delivery record, our team has strong clinical practice and pharma experience and focuses on the new era of MS/NMO/MOG research in remyelination and its challenges related to study designs, patient population, outcomes’ selection and combination of therapies.
Pain (including migraine, neuropathic pain): together with our trusted partners, we are addressing pitfalls of pain studies by focusing on sites’ and patients’ training and placebo response risk mitigation. Our regulatory experts, biostatisticians and MDs design accelerated and cost effective development strategies in new pain indications.
Stroke/Traumatic Brain Injury (including spasticity): experience conducting trials of symptomatic and disease modifying therapies by leveraging our site universe in neurology, rehabilitation medicine and intensive care units.
Neuromuscular disorders: broad experience across indications, including Myasthenia Gravis (MG), Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD) with a deep understanding of the science and the operational challenges of the area as well an established collaboration with Key investigators and sites across the globe.
Other rare genetic disorders: in collaboration with our CAGT and Rare Diseases Centres of Excellence, we deliver demanding projects by focusing on credible feasibility, patient centric and innovative solutions, including access to registries and cohorts.
Paediatric neurology: unique in house expertise in paediatric neurology and well established collaboration with advocacy groups in order to build realistic designs and address the needs of children and their families.
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.
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.
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.
Improve site selection, recruitment rates, and timelines with our study feasibility experts.
Design and execute trials for any indication with deep experience and innovative designs.
Tackle complex trials in all major regions, including North America, Latin America, Europe, and APAC.
Work with a stable, consistent team throughout the entirety of the project.
Pinpoint placebo effects vs. drug effects with enhanced signal detection strategies.
Access regulatory expertise in functional, cognitive, and behavioral endpoints across populations and indications.
Improving and accelerating clinical research in dementia by integrating the patient’s voice throughout the development journey
Jan 24, 2024
Regulatory considerations in designing clinical trials for Alzheimer’s disease
Jan 24, 2024
Increasing trial participation and population diversity in early-phase Alzheimer’s disease drug development
Jan 24, 2024
Building a program for patient-guided clinical research for Alzheimer’s disease
Jan 24, 2024