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Clinical Research Solutions

For over a decade, pharmaceutical, medical device companies and research clinicians have turned to us for clinical research services, diagnostics and therapeutic testing in the validation process for FDA approval. At BioSerenity we conduct Clinical research, Central Research Scoring Services (in US and International Trials) and Database Science Research.

Research Solutions

The Neuronaute will allow remote EEG recording in health care facilities or in the patient’s home. The Neuronaute can be used by investigators during clinical trials for:

  • Patient screening and selection: identify the best patient neurologic criteria for your clinical trial
  • Patient monitoring during the trial to detect potential neurological (EEG) changes and neurological (i.e.epilepsy) drug efficacy
  • Patients long-term monitoring for drug effectiveness and safety.

It consists of a 15 leads ECG for up to 14 weeks of recording in health care facilities or in the patient’s home. The Cardioskin can be used by investigators during clinical trials for:

  • Patient screening and selection: identify the appropriate patient cardiac criteria for your clinical trial
  • Patient monitoring during the trial to detect potential cardiac changes and cardiology drug efficacy and safety
  • Patients long-term monitoring for drug effectiveness and safety

Publications

Zero-crossing patterns reveal subtle epileptiform discharges in the scalp EEG 

Clinical diagnosis of epilepsy depends heavily on the detection of interictal epileptiform discharges (IEDs) from scalp electroencephalographic (EEG) signals, which by purely visual means is far from straightforward. Read full publication.

Building the case for epilepsy virtual clinics in the current healthcare environment

Access to quality healthcare remains a challenge that is complicated by mounting pressures to control costs, and now, as we witness, the unprecedented strain placed on our healthcare delivery systems due to COVID-19 pandemic. Read full publication.

Report of EEG finding on critically ill patients with COVID-19

In March 2020, we treated a cohort of 26 critically ill hospitalized SARS-CoV-2 infected patients who received EEGs to assess unexplained altered mental status, loss of consciousness, or poor arousal and responsiveness. Read full publication.

Assessment of signal quality measured with a smart 12-lead ECG acquisition t-shirt

Ambulatory ECG monitoring is typically achieved using portable de‐ vices with limited number of surface leads, autonomy, and length of recording. Smart garments with multiple conductive textile electrodes provide great promise to per‐ form continuous and comfortable ECG monitoring. Read full publication.

Comparison of the macro and microstructure of sleep in a sample of sleep clinic hypersomnia cases 

The purpose of this study was to elucidate the differentiating or grouping EEG characteristics in various hy- persomnias (type 1 and type 2 narcolepsy (N-1 and N-2) and idiopathic hypersomnia (IH) compared to an age- matched snoring reference group (SR). Read full publication.

Utility of home sleep apnea testing in high-risk veterans

The purpose of this study is to evaluate rate of incongruent outcomes (e.g., negative HSAT results despite high clinical symptomology) as well as differences in study quality metrics and predictors of OSA between veteran sleep patients and general sleep patients being evaluated by a home sleep test. Read full publication.

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BioSerenity, Inc.
3330 Cumberland Blvd. Suite 800
Atlanta GA 30339

1-800-753-3763