Clinical Trials Services

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’s Expertise

CortiCare is the premier provider of EEG services including remote monitoring and physician interpretation, on-site data collection, and storage solutions. Our expertise includes EEG training, in-home ambulatory collection, operations, and of course hands-on monitoring and physician interpretation of EEG to ensure the highest standard of quality service. We work diligently with our clients to establish protocols, practices, and processes that have become an industry standard for cEEG monitoring.

CortiCare has been providing support for Pharma Clinical Trails since its initial involvement in the multicenter NeoLev2 trial (Pediatrics. 2020 Jun;145(6):e20193182. doi: 10.1542/peds.2019-3182.) which required remote monitoring of continuous Video-EEG of neonates in the trial to identify seizures in real-time for immediate treatment intervention according to the protocol.  Since then, the CortiCare Clinical Trials Unit (CTU) has been involved with Phase 1 and 2 Pharma Clinical Trials in the US and many other countries providing critical EEG services for safety and documenting response to treatment.

CortiCare is not a Contract Research Organization (CRO) but we work with CROs and sponsors to provide their EEG monitoring and EEG interpretation services required for in-patient or decentralized operations. CortiCare is fully compliant with the International Council for Harmonization (ICH) and Guidelines for Good Clinical Practice (GCP) which is an internationally agreed standard that ensures ethical and scientific quality in designing, recording, and reporting of trial data. We also follow the IPEG (International Pharmaco-EEG Society) guidelines as it pertains to EEG collection and 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 in a CRO location or decentralized for EEG collection in a subject’s home.

Data can be stored and managed on our AWS CortiCloud, with secure, HIPAA/HITECH-compliant access. CortiCare is certified SOC 2 Type 2 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’s Services for Clinical Trials

  • Consultation in protocol design for both DCT and Site-based trials
  • EEG/ERP/PSG equipment and supplies for data acquisition
  • REEGT Staffing for EEG collections pre or post-dose
  • Remote monitoring to ensure high-quality EEG and data integrity
  • Pharmaco-EEG collection and qEEG analysis
  • EEG study interpretation by board-certified and fellowship-trained neurophysiologists
  • Polysomnography and Event Related Potentials (ERP)
  • Secure data storage and processing on our CortiCloud data server

Decentralized and Site-Based Clinical Trials

CortiCare’s teleneurology technologies and mobile staffing support Decentralized Clinical Trials (DCT) expanding the diversity of the trial population and in some cases reducing the timeframe and cost to complete a trial phase. Generally, these trials are conducted remotely instead of at a site facility, with patients remaining at home during most of the trial. Here, interactions with sites take place using software, phone applications, and/or connected devices. These tools feed sites and sponsors crucial trial data while providing face-to-face connections with participants through technology.

CortiCare can assist CRO’s and sponsors in implementing DCTs by:

  • Providing qualified staff to travel to remote subjects to initiate in-home EEG collection
  • Support for gathering eConsent and other electronic documentation
  • Employ data acquisition system for short or long-term recordings with support for Internet connectivity.
  • Establish remote EEG monitoring to ensure high-quality recordings
  • Providing cloud-based data storage and secure access for timely data review
  • Ensuring compliance with all appropriate regulations and guidance

On the other hand, CortiCare has worked closely with several CROs and sponsors to support site-based trials when a controlled environment is needed for dose-escalation studies with specific timed interventions, and discrete data collection points.  We can staff the site with qualified EEG Technologists to meet scheduled protocol stages as well as provide appropriate EEG acquisition systems, data upload support, and a secure cloud server with managed access.

Data Processing Services for Clinical Trials

CortiCare’s CortiCloud data center provides secure EEG storage and manages several data analysis packages that can be employed to process the EEG data for deeper insights or to detect targeted biomarkers.

QEEG or quantitative EEG is an ideal non-invasive biomarker given its ability to directly measure real-time brain activity. Whether you need 24/7 safety EEG monitoring for epileptogenic CNS drug effects, or acquisition of high-quality EEG for quantitative analysis of complex pediatric populations, let CortiCare bring our EEG expertise to your

For more information on CortiCare’s EEG Clinical Research Services, contact us today.