Clario has more experience in the design and conduct of neuroscience clinical trials than any other core lab in the world, highlighted by our support of the majority of Phase III Alzheimer’s Disease clinical trials incorporating imaging endpoints. Our world-class neuroscience team delivers specialized expertise in support of your trial, from protocol design through regulatory submission.
Unlock better evidence
Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. By capturing clinical data electronically, you can be confident that your patient’s data is high quality and regulatory-compliant. Put simply, eCOA avoids the quality and time issues associated with paper diaries and assessments, such as illegible answers, transcription errors and inconsistent or conflicting data. Clario’s eCOA solutions can also be easily integrated with connected devices, wearables or sensors to unlock additional evidence from your clinical trial.
Gain access to our world-class imaging expertise
Imaging for neuroscience clinical research can be extremely complex, often requiring qualitative and quantitative assessment of multiple imaging modalities. Clario understands the importance of high-quality imaging for neuroscience clinical trials and provides sponsors with end-to-end support across all neuroscience indications.
Reinventing clinical endpoint measurement
Clario’s complete wearable precision motion sensor solution delivers objective, high-frequency data combined with scientifically validated endpoints specific to your patient population.
CNS and neurological disorders in clinical research
Neuroscience clinical trials rely on the accurate collection of high-quality data for complex endpoints. We work together with clinical trial sponsors and sites to oversee qualitative and quantitative assessments to inform eligibility, safety and efficacy.
Clario can help you make sure you’re using the clinical research industry’s gold standard assessments and technologies for data collection, acquisition and analysis.
Clario’s innovative data collection tools and analysis methods can help patients and their caregivers with degenerative disorders such as Alzheimer’s disease, Parkinson’s disease, and Multiple Sclerosis more effectively report their symptoms while empowering study teams to objectively and quantitatively measure patient symptoms and functions. eCOA Multimedia, which captures audio, and images alongside traditional ClinRO, allows sponsors and study monitors to review and monitor data integrity.
Chronic neurologic dysfunction disorders
Clinical trials for functional disorders such as epilepsy, migraine and sleep disorders need robust tools, including medication management solutions and patient-reported outcomes (PRO) solutions that allow patients to easily and accurately report their symptoms and experiences in real-time, sometimes multiple times per day.
Patients diagnosed with neuropsychiatric disorders like addiction, depression and schizophrenia are afflicted with emotional, mental and behavioral symptoms that can make it difficult for them to accurately assess their condition. As a result, clinician-reported outcomes (ClinROs) are typically the primary endpoint in these trials. Objective measurements of a patient’s cognitive performance are also key, as both the individual’s diagnosis and treatment have the potential to impact a patient’s cognition.
When you partner with Clario for your neuroscience trial, we’ll help you control sources of error while providing you with high-fidelity data collected via several devices and modalities. We’ll also work with you to identify, quantify and collect data on subjective and objective efficacy endpoints and safety signals, including those that may have been impossible to measure in the past.
- Study design and protocol development. Our team works closely with sponsors at the outset to develop a protocol tailored to your neuroscience indication.
- Investigational site selection and support. We have experience working with thousands of imaging facilities throughout the world, constituting a global pre-qualified network of sites that will work for your study’s needs. We provide comprehensive imaging training to keep your trial running smoothly.
- Centralized image analysis. Our team has unparalleled experience in the assessment and quantification of neuroscience images.
- Regulatory expertise. We leverage our experience to support all aspects of regulatory submission.
Clario is the world leader in centralized imaging services, providing sponsors with comprehensive support for clinical trials across all neuroscience indications. Advanced medical imaging provides precise information on the brain, informing patient eligibility and drug efficacy. Molecular imaging and MRI protocols provide increasingly vital information, enabling sophisticated evaluation of disease states. Our comprehensive capabilities include acquisition and analysis of structural and functional MRI, MTR, ASL, DTI, neuromelanin, QSM, MRS and molecular imaging (FDG, amyloid, tau, FDOPA, investigational PET and DaTscan SPECT). Clario utilizes validated and compliant image processing workflows, as well as the latest state-of-the-art analysis methods for evaluating investigational therapies.
Capture outcome assessment data
Equip your trial with eCOA technology to collect ePRO diaries and eClinRO assessment including the Dyskinesia diary, the Hauser diary, the patient-reported electronic Columbia Suicide Severity Rating Scale (eC-SSRS), Expanded Disability Status Scale (EDSS), Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-COG) and the 6-Minute Walk Test, among others.
Measure cognitive and functional impairment
We offer easy-to-use digital cognitive assessments on our eCOA platform, and our precision motion sensor solution measures 100+ clinically validated endpoints using digital biomarkers.
Measure and monitor patient safety and disease progression
Collect and monitor patient safety and disease progression information with our cardiac safety and respiratory endpoints data collection technology. Clario offers early- to late-phase electrocardiogram (ECG) and blood pressure services. Also, Clario provides precise lung function testing to monitor drug safety using purpose-built devices and software customized to your protocol workflow for nearly 100% acceptable data in real-time.
Achieve improved accuracy and reproducibility in imaging
Clario offers advanced imaging technology, a network of thought leaders and a comprehensive range of imaging modalities, including fMRI and EEG.
Prioritize the patient
We review patient demographics, journey mapping and expectations during our solutions development process to ensure our data capture tools promote patient centricity in your trial.
Capture patient data at home
Clario’s advanced technology supports virtual or hybrid trial design in CNS studies, including virtual visits.
Clario’s therapeutic strengths and areas of focus include global support for clinical trials in:
- Alzheimer’s Disease (AD) and other Dementias
- Multiple Sclerosis (MS)
- Parkinson’s Disease (PD)
- Stroke and Stroke Devices
- Neonatal, Pediatric and other Rare Diseases
Additional indications our team has supported include:
- Angelman’s Syndrome
- Canavan Disease
- Contrast Agents
- Creutzfeldt-Jakob Disease
- Cushing’s Disease
- Down’s Syndrome
- Fabry Disease
- Hunter Disease
- Huntington’s Disease
- Intracranial and Intraventricular Hemorrhage
- MELAS Syndrome
- Molybdenum Cofactor Deficiency
- Multiple System Atrophy
- Progressive Supranuclear Palsy
- Psychiatric Disorders (Schizophrenia, PTSD)
- Spinal Cord Injury
- Traumatic Brain Injury and Brain Contusion
Talk to a specialist
Our team of experts is available to address any questions you may have about our neuroscience solutions. Submit your contact information and we’ll be in touch shortly.