Clinical Research
Supporting decentralized home and facility-based trials; collecting high quality EEG data with GCP compliant processes.
“I have gotten a lot of feedback from parents that have said that they were really impressed with Michael and how great he was with their children during the EEG setup. They said he was very patient and made them feel comfortable. I know that the parents are always nervous about the EEG so you guys must have some great techs!”
– Clinical Research Coordinator, Chicago, IL
ABOUT OUR RESEARCH
- Neurotech has been providing remote-monitored EEGs in patient homes since 2006 and for decentralized trials since 2019.
- We are honored to help relieve the time and travel burden families experience during a clinical trial. We serve patients in their homes, schedule according to protocol, and work within family schedules.
- Our employed EEG technologists set up remote monitored EEGs for participants of all ages (including neonates) and abilities. Following strict, study-specific protocols, our staff works with families to provide an optimal EEG experience, facilitating trial recruitment.
INVESTED IN COMPLIANCE
Transforming lives. Facilitating enrollment.
- Neurotech has invested in GCP and FDA 11 compliant quality management systems to manage documentation in its eMTF and document training activities, internal protocols, and guidelines.
- As an experienced vendor for clinical trials, Neurotech has established processes in place for review of documentation, participating facing documents, secure communications, data transfer, and more.
- We work with each sponsor to follow the established protocols, customize EEG setups to include PSG (if needed), tracking KPIs, and meeting the unique needs of their clinical trial.
REMOTE MONITORING QUALITY
- Neurotech's monitored EEG testing virtually eliminates the need for expensive, repeated tests. Technical problems occur during long-term EEG tests. Without monitoring, these complications go undetected and patient EEG test results are compromised.
- All Neurotech Remote Monitoring Technologists work from secure office locations around the country - never from their home.
- When EEG reading begins, Neurotech's monitoring technologists log in to the recording equipment and begin intermittent monitoring. Technologists check hourly and verify the technical integrity of the EEG video, impedances, and the patient on camera. These hourly checks are documented in the Neurotech database.
- On-call technologists may be dispatched to fix technical issues that may occur during the monitoring. Remote monitoring technologists are available 24 hours a day, 7 days a week to answer patient questions or concerns.
EEG SERVICE QUALITY
- EEG Technologists are employed (never subcontracted) and based from secure office locations. All are experienced in serving adult and pediatric patients with behavioral disorders.
- Competencies are confirmed and reviewed annually with performance measures on the quality of the EEG setup.
- Continuing education is provided by epileptologists.
- Neurotech’s leadership is actively involved in both local and national efforts in the industry with our leaders serving on the boards of ASET, CSET, and local EEG organizations - playing key roles in developing EEG standards and quality measures.
GOLD STANDARD EEG SETUP
- EEG Technologists travel to patient homes to perform the EEG.
- Technologists explain the procedure to the patient/caregivers and apply 19-23 EEG electrodes using 10-20 international system with paste/tensive.
- The patient's head is wrapped to secure electrodes. This is done with attention to the patient's comfort.
- Patients are instructed to push the event button to mark seizures or events that occur during the recording period.
- The technologist will disconnect the EEG when the recording is completed.
OPTIONAL CENTRAL PHYSICIAN EEG INTERPRETATION
- Board Certified adult and pediatric epileptologists
- Credentialed according to Joint Commission Standards
- Data & reports on Neurotech's secure online Physician Portal
- Standard process: EEG interpreted 24-48 hours following upload