Brain Monitoring for Clinical Trials
Real-time EEG Data, Monitoring, Management and Analysis with a Global Reach
Electroencephalography (EEG) is an ideal biomarker for successful drug development, particularly in the evaluation of seizure liability and monitoring changes in sleep. Sponsors with NDAs for neurological disease are adopting EEG for a wide range of functions: to track natural history, safety, pharmacodynamic assessments, and biomarker development.
CortiCare provides EEG clinical research services worldwide. CortiCare is a 21 CFR Part 11 compliant provider of clinical outpatient and in-patient EEG services. We serve hospital neuro-ICUs, Neonatal ICUs and Epilepsy Monitoring Units daily, compliant to all HIPAA standards.
CortiCare works directly with sponsors or CROs and operates its EEG monitoring and EEG interpretation services under GCP standards as required for in-patient operations. CortiCare is fully compliant with ICH, GLP, and GCP as it pertains to EEG and EEG interpretation. Our broad expertise translates to a single source for EEG study design, site selection, standardized data acquisition, management, and interpretation in clinical trials for CNS pipeline drugs.
Data can be stored and managed on our AWS CortiCloud, with secure, HIPAA/HITECH compliant access. CortiCare is certified SOC 2 Type 1 compliant on the Security Trust Services Criteria through an independent auditor and CortiCare adheres to GDPR and CCPA guidelines for personal data privacy.
Through our Advisory Board, CortiCare can team with leading academic institutions to provide in-depth analytics, in addition to the normal quantitative EEG analysis.
CortiCare EEG Clinical Research Capabilities and Activities
- EEG and video data uploaded to the secure CortiCloud™ AWS EC2 Cloud server
- EEG data processed for quantitative EEG analysis, sleep staging, and seizure detection
- EEG interpretation from our board certified highly experienced neurophysiologists
Consulting and Design
- Trial design and coordination with a team, includes a Scientific Liaison, Clinical Trial Project Manager, Lead Data Manager, Informatics Project Liaison, and a Regulatory Expert
Clinical Research Coordination Activities
- Protocol design
- Statistician support
- Pharmacometrics and biomarker development
- Custom database configuration
- Regulatory support
For more information on CortiCare’s EEG Clinical Research Services, contact us today.