Clinical Trials

Single source for EEG study design, data acquisition, management and interpretation in clinical trials for CNS pipeline drugs.

CortiCare’s Services for Clinical Trials

  • Consultation in protocol design for both DCT and Site-based trials
  • EEG/ERP/PSG equipment and supplies tor 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
EEG as Biomarker

EEG is an ideal biomarker for successful drug development, particularly in the evaluation of seizure liability and monitoring changes in sleep.

Decentralized and Site-Based Clinical Trials

CortiCare’s teleneurology technologies and mobile stalling 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 cooductecl 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.

Data Processing Services for Clinical Trials

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

QEEG or quantitative EEG is an ideal non-invasive biomar1’er 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 ot high-quality EEG for quantitative analysis of complex pediatric populations, let CortiCare bring our EEG expertise to your

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 tully compliant with the International Council for Harmonization (ICH) and Guidelines tor Good Clinical Practice IGCP) 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 collectioo 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