Neuroscience

With an established pedigree in Neuroscience, Biotrial provides translational solutions that closely link non-clinical and clinical development using in-house data validation and back translation. Biotrial’s excellence is driven by our team of in house and external neurologists’ experts as well as project management teams with significant expertise in Neuroscience trials. We offer an end-to-end solution for your Early Phase needs or bespoke services according to your needs.

Biotrial-Corelab-Neurology-Cardiology

Global Approach

Preclinical Services

  • GLP regulatory/early safety derisking (Core Battery)
  • Safety Pharmacology Studies: Follow-up and Supplemental Studies (abuse liability, memory performance, seizure liability, change in sleep
  • Biotrial’s CNS efficacy offer includes validated models (Psychiatry, Schizophrenia, Neurological Disorders, Cognition, EEG)

Clinical Services

Extensive early development expertise in Phase I and II worldwide:

  • Medical expertise & Scientific advice
  • Study feasibility assessment
  • Site selection / qualification
  • Site contracting & payment support
  • Clinical trial management
  • Regulatory services
  • Pharmacovigilance services
  • Clinical monitoring
  • Medical monitoring
  • Central lab services
  • Supply management

Biometrics

  • EDC and ePRO/eCOA
  • Central Randomization
  • DSMB/IDMC support
  • Data Management
  • Statistical consulting services and statistical analyses
  • CDISC Deliverables for FDA, PMDA (Japan) and NMPA (China) submissions

Core Lab Services

  • EEG Neurologist Reading
  • qEEG (spectral analysis)
  • Seizure/Spike Quantification
  • ERP (auditory, visual)
  • PSG, Sleep Endpoints
  • Source Localization
  • Functional Connectivity

Bioanalytical Services

Drug development programs support by developing and validating bioanalytical LC-MS/MS methods and performing high-throughput analysis for accurate quantification of drugs, from matrices such as blood, plasma, cerebrospinal fluid, and brain tissue.

Areas of Expertise

Brain1
Neuron1
Neurodevelopment

Neurodegenerative disorders

Alzheimer’s disease, Dementia, Parkinson’s disease, Multiple Sclerosis, Huntington’s disease, Osteoporosis, Rheumatoid Arthritis

Neuromuscular disorders

Amyotrophic Lateral Sclerosis (ALS), Duchenne Muscular Dystrophy (DMD)

Neurodevelopmental disorders

Angelman Syndrome, Fabry Disease

Fear
Diabetic Neuropathy
Back Pain

Psychiatry

Depression, Schizophrenia, Anxiety, Panic disorder

PNS disorder 

Peripheral neuropathy, radiculopathy

Pain

Back pain, Migraine pain, Neuropathic pain

Vascular
Insomnia
Epilepsy

Vascular Injury

Acute Ischemic Stroke, Diabetic Neuropathy, Peripheral Neuropathy

Sleep disorders

Narcolepsy, Insomnia

Epilepsy

Biotrial Therapeutic Areas Neuroscience Experts 2048x1296

Neuroscience Expertise

  • Translational approach from Non-Clinical to Clinical development.
  • Full-service Neuroscience solutions.
  • Flexible Processes and Solutions.
  • In-house & external neurologist experts
  • Partnerships with consultants, KOLs and expert investigators at universities, institutes, hospitals, and clinics
  • Non-Clinical, Clinical and operational expertise in CNS practices.
  • Global trial management teams with extensive experience managing and executing neuroscience trials

Pharmacodynamics tests & models

Our Clinical Pharmacology Scientific Services are numerous given our focus on Early Clinical Development and

Translational research. Different pharmacodynamic tests and models are available related to assessment of CNS effects,including ones that are relevant to pain, cognition and psychiatric disorders..

Both our clinics in France and in the US include dedicated CNS-testing areas where study participants can take these tests within a quiet and adapted environment.

Biomarker driven

EEG, ERP, PSG, Cognitive testing

Imaging (PET, MRI, CT, Sonography)

Wet: Ceresbrospinal Fluid (CSF) sampling

Human models

  • Panic attack: CCK challenge
  • Generalized Anxiety Disorder (GAD): CO2 challenge
  • Sleep disorders/Insomnia: noise
  • Cognitive disorders: Scopolamine challenge
  • Schizophrenia: Ketamine challenge
  • Daytime sleepiness: sleep deprivation
  • Pain models:
  • Acute Pain: Thermal, mechanical, cold pressor
  • Inflammatory Pain: UV induced erythema
  • Neuropathic Pain: Capsaicin alone or with UV
  • Cognition models:
  • qEEG measures in high frequency bands
  • ERP (P300 or SART+P300)
  • Information processing tests
    DSST, RVIP, Stroop Test, Simon Task
  • Attention/Vigilance tests
    CFF, SRT/CRT, DAT, PVT, CPT, TMT A and B, DV
  • Memory tests such as SWM, NWM, LMT, N-back
  • Neuropsychiatric questionnaires
    MINI, MADRS, C-SSRS, PANSS, BPRS, STAI, CDR, NPI, …b

Added Value

  • Neurologists’ medical network in Europe and in the US
  • Non-Clinical & Clinical development – Translational approach
  • Dedicated EEG & Sleep facilities: Preclinical unit, EU & US CPUs
  • Standardized process for robust endpoints
  • Global coverage

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