CNS trials are complex due to heterogeneous patient populations and subtle treatment effects. Our clinical trial design services incorporate the latest cognitive neuroscience research and statistical approaches to create protocols optimized for CNS indications.
CNS Clinical Trial Design & Optimization
Design smarter, more efficient CNS trials by integrating cognitive science principles and real-world patient insights to improve signal detection and reduce errors.
Overview
Our Services
CNS Clinical Development Planning
Strategic roadmaps integrating cognitive science, patient subtypes, and regulatory insight to guide CNS programs from preclinical to late-stage trials.
Hypothetical: A neurology-focused biotech progressing a GABA-modulating compound from IND-enabling studies to a Phase I trial in generalized anxiety disorder. We map a 24-month plan including translational biomarker workups, EEG safety thresholds, and parallel pre-IND meetings with EMA and FDA to align on cognitive endpoints and trial population.
Protocol Design and Optimization
Mechanism-linked cognitive endpoint design, adaptive trial strategies, and inclusion/exclusion logic for complex CNS indications.
Hypothetical: For a Phase II trial targeting executive dysfunction in early Huntington’s disease, we develop an enriched enrollment protocol leveraging cognitive screening tools, digital attention measures, and Bayesian interim futility analysiss.
CRO and Vendor Selection
Expertise in neuro/CNS-specific CROs, cognitive eCOA vendors, digital biomarker platforms, and neuroimaging services.
Hypothetical: A biotech developing a glioblastoma adjunct therapy aimed at preserving post-surgical cognitive function needed a hybrid neuro-oncology CRO and a digital cognition vendor. We ran a competitive RFP across EU and US, scoring on neuro-oncology delivery experience and wearable EEG integration.
Site Feasibility and Selection
CNS trial site identification based on prior cognitive trial performance, specialist access, and patient registry alignment.
Hypothetical: For a schizophrenia negative symptoms trial, we leveraged data from three global trial registries and 50+ publications to identify 18 high-performing psychiatric research centers across the UK, Brazil, South Korea, and Slovakia.
Trial Management and Oversight
CNS-adapted oversight including dropout risk analytics, rater reliability training, and cognitive signal monitoring.
Hypothetical: In a Phase III cognitive-enhancement trial for mild cognitive impairment (MCI), we built a live trial dashboard monitoring rater drift, dropout predictors, and digital performance consistence.
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