Despite the enormous steps that have been taken towards better understanding of central nervous system (CNS) diseases, healthcare systems worldwide face an unprecedented challenge in dealing with the unmet needs associated with neuropsychiatric disorders. CNS diseases, and mental health disorders are one of the major health challenges of the 21st century, especially in light of an aging population (Race et al., 2013).
SCOPE’s CNS / neurology team is here to help your clinical development program flourish with innovative recruitment strategies, strong site networks and local standard of care knowledge across an array of neurological disorder conditions. Our dedicated CNS project managers combine best practice and up-to-date knowledge of the relevant rating instruments in neurologic and psychiatric study development, in addition to strong local and global regulatory insight.
SCOPE`s team has conducted a variety of CNS studies across diverse major etiologies. With a full range of services and profound experience, we can define a strong development plan for your drug, device, or combination product and oversee the study from conception to delivery of the final report. We have successfully conducted more than 30 studies in neurology involving more than 1,200 clinical sites and 7,000 patients in both adult and pediatric indications. SCOPE has established networks of investigators across different CNS indications, by maintaining close relationships with neurologists, psychiatrists, pain/palliative specialists, and key opinion leaders.
We are able to provide rapid and accurate feasibility estimates at the outset. We build upon our long-term relations with experienced, qualified, and motivated sites to deliver your trial. From identifying the best sites, recruiting the right patients, to assuring assessments are properly completed by trained personnel, SCOPE can meet challenges and targets across a wide range of study designs and hard to recruit indications in CNS. Your program will be monitored by experienced clinical research associates, project managers, medical monitors, and scientists who are familiar with the specific nuances, pitfalls, and opportunities in these types of studies.
CNS trials rely on subjective endpoints, making the selection of appropriate psychometric instruments critical for demonstrating efficacy. Our team advises on guideline-conforming tools and ensures consistency through standardization and rater training.
To reduce patient burden, we prioritize technology-driven data collection, including e-PRO instruments, smartphone apps, and tablets. SCOPE collaborates with selected eCOA providers, and our monitors support study coordinators in training patients for accurate, timely data capture. Our experienced project managers proactively identify study risks, while continuous site communication ensures training, assessment, and data quality across all trial centers.
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