Central Nervous System (CNS) and Neurological Disorders in Clinical Research


Central nervous system (CNS) and neurological disorders are challenging to diagnose and monitor, as many lack validated biomarkers or biomarker surrogates. Instead, CNS studies rely heavily on variable and subjective outcome assessments, exposing sponsors to a high risk of study failure. So how can you successfully demonstrate safety and efficacy with certainty?

With experience in 200+ CNS indications, ERT can help you control sources of error and and provide you with high-fidelity data collected via a number of devices and modalities. We’ll 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.

Curious about the possibilities for innovation in CNS research? Learn more about opportunities for advancing this therapeutic area while protecting ROI.

NEURODEGENERATIVE DISORDERS

Measure patient cognitive and physical impairment with precision


ERT’s innovative data capture tools and assessments can help patients with degenerative disorders such as Alzheimer’s, Parkinson’s, and multiple sclerosis communicate more effectively about their symptoms while empowering study teams to objectively and quantitatively measure their condition.

Monitor progression more holistically through eCOA Multimedia, which captures audio and photos alongside assessments.

NEURODEGENERATIVE DISORDERS
NEURODEGENERATIVE DISORDERS

NEURODEGENERATIVE DISORDERS

Measure patient cognitive and physical impairment with precision


ERT’s innovative data capture tools and assessments can help patients with degenerative disorders such as Alzheimer’s, Parkinson’s, and multiple sclerosis communicate more effectively about their symptoms while empowering study teams to objectively and quantitatively measure their condition.

Monitor progression more holistically through eCOA Multimedia, which captures audio and photos alongside assessments.

Capabilities

Capture Outcome Assessment Data

Equip your trial with eCOA technology to collect ePRO and eClinRO diaries including the Dyskinesia diary, Hauser diary, 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 via Cogstate on our eCOA platform, and our precision motion sensor solution measures 100+ clinically validated endpoints using digital biomarkers.


Reduce Bias and Data Variability

Our Advanced Training for raters, caregivers and patients is customized for every study and can help sponsors manage the risks of subjectivity or the placebo effect impacting their trials.


Achieve Improved Accuracy and Reproducibility in Imaging

ERT’s neuroimaging expertise is wide-ranging and includes MRI, PET, CT, and SPECT.


Measure Patient Safety and Disease Progression

Capture and monitor patient safety and disease progression with our cardiac safety and respiratory data collection technology.


Prioritize the Patient

By focusing on patient demographics, journey mapping, and experience, we ensure all of our solutions are based in patient centricity.

CHRONIC NEUROLOGIC DYSFUNCTION DISORDERS

Chronic Neurologic Dysfunction Disorders

Empower patients with real-time reporting and monitoring technology


Clinical trials for functional disorders like epilepsy and migraine need robust tools, including medication management solutions and PROs that allow patients to easily and accurately monitor and report their own symptoms and experiences in real-time, sometimes multiple times per day.

CHRONIC NEUROLOGIC DYSFUNCTION DISORDERS

Chronic Neurologic Dysfunction Disorders

Empower patients with real-time reporting and monitoring technology


Clinical trials for functional disorders like epilepsy and migraine need robust tools, including medication management solutions and PROs that allow patients to easily and accurately monitor and report their own symptoms and experiences in real-time, sometimes multiple times per day.

Capabilities

Capture Outcome Assessment Data

ERT’s eCOA technology collects ePRO and eClinRO diaries including the electronic Columbia Suicide Severity Rating Scale (eC-SSRS).


Measure Cognitive Impairment

Available on our eCOA platform, Cogstate’s fit-for-purpose digital cognitive assessments reduce start-up times, administration times, error rates, and placebo response rate. 詳細を見る.


Reduce Bias and Data Variability

With training customized for your study, you can be confident that you’re reducing the risk of capturing outcome assessment data that is biased or inaccurate.


Achieve Improved Accuracy and Reproducibility in Imaging

ERT offers advanced imaging technology, a network of thought leaders, and a comprehensive range of imaging modalities, including fMRI and EEG.


Monitor Patient Safety

Protecting patient safety is critical to any clinical trial. ERT’s precision cardiac safety solution can help you protect patients.


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.

Psychological Disorders

Improve eClinRo quality with training and assessment review


Patients diagnosed with psychological disorders like depression and schizophrenia are afflicted with emotional, mental, and behavioral symptoms that can make it difficult for them to accurately assess their own condition. As a result, 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 the patient’s cognition.

Assess and monitor progression with more clarity and certainty using eCOA Multimedia. Central raters are able to review audio recordings of these assessments to ensure consistent, high quality clinician assessments and scoring.

PSYCHOLOGICAL DISORDERS
PSYCHOLOGICAL DISORDERS

Psychological Disorders

Improve eClinRo quality with training and assessment review


Patients diagnosed with psychological disorders like depression and schizophrenia are afflicted with emotional, mental, and behavioral symptoms that can make it difficult for them to accurately assess their own condition. As a result, 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 the patient’s cognition.

Assess and monitor progression with more clarity and certainty using eCOA Multimedia. Central raters are able to review audio recordings of these assessments to ensure consistent, high quality clinician assessments and scoring.

Capabilities

Collect Clinician and Patient-Reported Outcome Assessments

Along with ePRO diaries, including the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS), ERT’s eCOA solution supports eClinROs, including the Hamilton Depression Rating Scale (HAM-D), Montgomery-Åsberg Depression Rating Scale (MADRS), and Positive and Negative Syndrome Scale (PANSS).


Reduce Bias and Data Variability

Training for patients, caregivers, and raters unique to your study can help sponsors address risks to data quality, like subjectivity, bias, and the placebo effect.


Measure Cognitive Impairment

Experience quicker start-up times and administration times as well as reduced error rates and placebo response rates with Cogstate’s fit-for-purpose digital cognitive assessments, available via ERT eCOA. 詳細を見る.


Capture Patient Data At Home

ERT has the technology to support virtual or hybrid trial design in CNS studies, including virtual visits.


Prioritize the Patient

We use a patient-centric focus in our solution design process based on demographics, patient journey mapping, and modern patient expectations.


Measure Patient Safety and Disease Progression

Using ERT’s respiratory and cardiac safety solutions, sponsors can capture and analyze valuable safety and disease progression data.

Other CNS Indications

Capture data with accuracy and precision


  • ERT has experience in more than 200 CNS indications, including pain, addiction, and sleep disorders.
  • Our science, project management, medical, regulatory, and technology teams are equipped with knowledge to help you improve your data quality and experience better trial outcomes.
  • We can develop homegrown and customized data capture tools for your patient population, and make sure you’re using the clinical research industry’s gold standard assessments and technologies for CNS data collection.

ERT CNS EXPERIENCE


157 APPROVALS
525K PATIENTS
7.2K SITES
1.7K TRIALS


専門家に相談


With decades and thousands of trials worth of experience, ERT has the knowledge and flexibility to provide proven eClinical technology solutions for your next central nervous system trial or post-approval study. To find out how our technology or services can fit your protocol, submit a contact form. A member of our team will be in touch with you shortly.