The NeuraMetrix solution provides Biopharmaceutical companies with a much more precise, accurate, and cost-effective Digital Cognitive Biomarker for Clinical Drug Development
The gap
The main issues for drug trials within neurological diseases and psychiatric disorders today are:
Measurements in clinical trials are often subjective, imprecise, lack repeatability and deliver poor statistical quality of results
Do not have good and early indicators of safety and efficacy
Difficult to successfully develop new drugs when the cohort is based on patients where the disease has already progressed beyond where the drugs can have an impact
No ability to monitor "in real-time" the effect on each trial participant
Difficult to measure cognitive side effects of their drugs
In neurology and psychiatry, diagnosis is often incorrect
Clinical trials are often very demanding on the subjects, including multiple visits to the clinic
NeuraMetrix' highly precise and easy to implement digital biomarker fills an important gap long sought after by the biotech and pharmaceutical industry
The NeuraMetrix clinical support software for neurological diseases and psychiatric disorders drug trials solves these problems:
Much more sensitive and less variable indicators of disease state and efficacy in drug trials
Objective measures of disease state, disease progression and response to therapy
NeuraMetrix have developed fingerprint for each disease, which the diagnosis can be compared to
Ability to identify patient segmentation strategies
Granular quantification of disease symptoms
Very automated system, with easy to use interfaces
Almost no burden on the patient - all in the background and no tests
This enables biotech and pharmaceutical companies to:
Deploy smaller, faster clinical trials
Get early warning signals of whether trial will be successful or not
Micromanage the set of subjects, dependent on the response to treat
Change the sample size of the trial very quickly, dependent on the result to date
Verify that a subject's diagnosis is correct
Increase prognostic enrichment: selection of patients at high risk of disease-related endpoints
Increase predictive enrichment: selection of patients sub segment with disease stages more likely to drug treatment
Have trials designs which include pre-randomization baseline "run-in" period to exclude patients whose symptoms resolve spontaneously or have highly variable baseline symptoms
Identify patients likely to adhere to treatment or other variables
Identify responders vs. non-responders by quantifying patient symptoms and track longitudinally
Make it easier for the cohort
Resulting in:
Faster go/no go decisions
Decreased variability
Decreased heterogeneity
Increased study power
Better management of drug trials
Fewer participants dropping out of drug trials
Less risk
Less cost
Headquarters
NeuraMetrix, Inc. 65 Merrimon Ave #1181 Asheville, NC 28801-2322 U.S.A.
NeuraMetrix is a Medical Device company. It offers a novel, unique, highly accurate digital biomarker to detect and monitor a range of Neurological diseases and Psychiatric disorders.
Copyright NeuraMetrix, Inc. (a North Carolina corporation) 2023. CE marked according to MDD Class I devices, directive 93/42/EEC. Not FDA cleared. Website produced by Pinevision