Neuroscience & Psychiatry

Regulatory Strategy & Support

Neurological clinical trials face challenges like navigating evolving regulatory guidelines, obtaining informed consent in vulnerable populations, and defining meaningful endpoints while managing confounders like placebo response, all essential for compliance and trial success.

Allucent interacts extensively with international regulatory agencies to stay updated with the requirements and developments in neurological, pain, and psychiatric trials and treatments, in order to navigate the unique challenges these trials present including:

• Implementation of streamlined regulatory pathways and expedited approvals
• Patient–centric approaches
• Use of biomarkers and surrogate endpoints.

Study Design

Neurological clinical trials encompass a wide range of complex design challenges ranging from the assessment of brain penetration to enable translational PK/PD for dose selection, to high placebo response in certain psychiatric indications and pain, necessitating careful training and control measures. Neurological and psychiatric trials also often require multiple subjective assessment scales, demanding standardized and extensive rater training. Additionally, increasing use of invasive drug administration and fluid biomarker sampling, along with specialized imaging, further complicate trial execution and design.

The combined expertise of Allucents clinical pharmacology experts, regulatory strategists, biostatistical consultants, and medical affairs team provide robust and efficient design recommendations, from first-in-human neurological and psychiatric studies through to pivotal trials. This includes defining appropriate and clinically meaningful endpoints, dose optimization, managing placebo response, and supporting long-term follow-up to maximise quality and impact of the research, ultimately leading to better patient outcomes and more effective treatments.

Site Networks

Allucent has establish relationships with site and hospital networks worldwide with experience and expertise in conducting neurological clinical trials across all phases of development, including those requiring complex neuroimaging and neurophysiological monitoring by radiologists and neuroimaging specialists for image acquisition, interpretation, and protocol development.

Patient Recruitment & Retention

Ensuring diverse, representative patient populations in neuroscience trials is often required by regulators but may pose challenges to patient recruitment, particularly in rare neurological conditions. Additionally, many of these trials require prolonged follow-up periods, which may result in loss of study subjects over time.

Our Dedicated Patient Engagement Team offers tailored strategies to support patient recruitment, consent, engagement, diversity and compliance, working across neurological, pain and psychiatric conditions. To ensure patient participation is more accessible and less burdensome Allucent implements on-site, decentralized, and hybrid trial designs such as those that include DCT. By utilizing remote assessments, wearables, eCOAs, reliable caregivers, and site networks we can further enhance recruitment and retention strategies and improve trial success.

Preferred Partners

Allucent has an established list of industry leading preferred partners providing technology solutions that collectively enhance the design, implementation, and management of neuroscience clinical trials, including:

• EEG
• Neuroimaging (MRI, fMRI, PET, CT) acquisition and centralized reading
• ePRO & eCOA (including rater scales and training)
• Entry/exit interviews
• Wearables
• Fluid biomarkers
• Cognitive batteries

Our partners provide streamlined and efficient collaboration, ensuring patient safety and resulting in exceptional data quality.