Therapeutic Expertise
CNS & Neurology
Our neuroscience team runs complex central nervous system trials, from neurodegenerative and movement disorders to epilepsy, migraine and stroke. We combine physician oversight with rigorous, standardised endpoint capture.
CNS programmes demand exceptional endpoint discipline: cognitive and functional scales are rater-dependent, disease progression is slow, and placebo response can obscure a real signal. We calibrate raters, apply centralised review and design fit-for-purpose endpoints so that treatment effects are detected reliably and are acceptable to the FDA and EMA.
Addressing common pain points in cns & neurology clinical trials
Rater variability on cognitive and functional scales
Subjective neurological and cognitive assessments are prone to inter-rater variability that can mask a true treatment effect.
We train and calibrate raters and apply centralised, blinded review to protect assay sensitivity across sites.
Slow disease progression and long timelines
Neurodegenerative diseases progress slowly, making change hard to measure within a feasible trial duration.
We integrate fluid and imaging biomarkers and enrichment strategies to shorten timelines and sharpen the efficacy signal.
Complex regulatory expectations
CNS endpoints and trial designs face heightened regulatory scrutiny.
Our regulatory team aligns endpoints and analysis plans with current FDA and EMA guidance from protocol design onward.
Resources
CNS & Neurology clinical trial resources
Alzheimer’s Disease Clinical Trials
Endpoint strategy and trial design in Alzheimer’s disease.
Parkinson’s Disease Clinical Trials
Navigating motor and non-motor endpoints in Parkinson’s research.
Multiple Sclerosis — Overcoming Clinical Trial Challenges
Design and endpoint considerations in MS trials.
Evidence & insights
CNS & Neurology white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
Optimizing Clinical Trials for Acne Vulgaris
White paper · PDF ↗Age-related Macular Degeneration Clinical Trials
White paper · PDF ↗Alzheimer's Disease Clinical Trials
White paper · PDF ↗Exploring Amyotrophic Lateral Sclerosis (ALS)
White paper · PDF ↗Generalized Anxiety Disorder - Clinical Endpoints, FDA Approvals, and Trial Enhancements
White paper · PDF ↗Understanding ADHD Clinical Trials
White paper · PDF ↗The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your CNS & Neurology clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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