EEG Brain Monitoring for Clinical Trials
Accurate, reliable, timely EEG data helps get critical drugs to market faster
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Clinical Trial Services:
EEG brain monitoring for clinical trials
Contract research organizations (CROS) and sponsors expect seamless execution of clinical trials that require EEG validation, with expertise built on solid experience. With tight timelines, rapid pipeline demands and budget constrictions, a trusted partner is essential. Lifelines Neuro delivers clinical trial oversight and execution with a dedicated team of registered EEG technologists since 2014.
Our internal EEG expertise can help you de-risk your trial with early consultation. Our EEG technologists are highly skilled (technical and adaptive) and experienced in pediatric as well as adult EEG and can be posted to participant homes, clinics, hospitals, and clinical trials sites.
With time-tested and reliable neurodiagnostic equipment and cloud-based software for rapid review, we can significantly reduce turnaround times for video EEG recording and review, which can ultimately reduce the time-to-market for critical drugs. Better systems mean more accurate, reliable, and timely data, helping to avoid costly mistakes for seamless execution of clinical trials.
Adjudication Services
Lifelines Neuro strongly suggests and offers Adjudication Services in all phases of trials. This service can alleviate sponsor concerns over potential decision threshold variability amongst Central Readers in EEG.
Why adjudication services?
For trials that have a potential central nervous system impact, adjudication services support:
Patient Safety
By ensuring abnormalities associated with seizures are systematically identified and confirmed prior to compound exposure.
De-risking of Clinical Trials
By ensuring the compound has functionally penetrated the blood brain barrier and any abnormalities associated with seizures can be attributed to compound exposure rather than under screened pre-existing risk.
Standardization of Endpoints
By ensuring that the criteria are standardized in the interpretation of EEGs, leading to more consistent readings across the subject population.
Regulatory Compliance
By demonstrating rigorous processes are in place to address safety concerns.
Mitigation of Inter-rater Variability
By providing a structured process for resolving differences in interpretation leading to more reliable results.
Adjudication Services Include:
- A highly skilled and regarded team of EEG readers, selected for their expertise in each trial application. Get the right reader for the right reason.
- Customization according to client’s needs:
- Standardized criteria for identifying abnormalities explicitly marked by each reader and adjudicator.
- Go/No-Go criteria implemented for exclusion, monitored inclusion, and discontinuation from trial.
- Standardized individual EEG reports with summaries per cohort.
- Machine Learning supported EEG reads through our partnerships.
Preparation and Support Services
Global clinical trials present logistical and infrastructure challenges, with compliance issues, and varying levels of EEG qualifications for site staff. Preparation, educational training, and validation of site staff are key to delivering successful outcomes. Our team provides highly effective live, remote and onsite training sessions, while our vigilance monitoring allows for real-time intervention and support during EEG testing.
Exceptional EEG means a more efficient clinical trial process
The Lifelines Neuro Clinical Trial Services EEG team can help enhance efficiency, decrease cost, and improve accuracy, – all with more effective outcomes.
We act as your EEG consultant, helping to navigate the complexities with turnkey solutions. Staff have a combined 248 years of EEG experience, with academic medical center and clinical trial experience.
Vigilance monitoring is provided by U.S.- based registered EEG technologists who proactively view live video EEG to monitor quality and troubleshoot in real time. This ensures high quality subject data is technically acceptable to control subject acquisition costs.
Our Global Project Lead is a physician with 30+ years in clinical trials, 15 with EEG, to expertly provide study and protocol design.
Highly qualified neurologists act as Central Reviewers, providing consistent EEG interpretation and assisting in study eligibility to improve study protocol efficiency.
Central Reviewers can also provide adjudication services.
Compact and easy-to-use, Lifelines Neuro’s rugged hardware and advanced EEG technology are used by top research centers around the world. The cloud-based platform provides consistency at all sites.
Data security features include:
- Systems are located in redundant SOC2 compliant data centers.
- Data transmissions are secured with the HTTPS TLS 1.2 protocol.
- Data encryption at the AES-256 level, at rest and in transit.
- Cloud solution fulfills the requirements of CFR 21 Part 11.
- Software offers unique user accounts with password complexity and dual factor authentication enabled.
- Remote support is offered through an encrypted platform.
Exceptional EEG means a more efficient clinical trial process
The Lifelines Neuro Clinical Trial Services EEG team can help enhance efficiency, decrease cost, and improve accuracy, – all with more effective outcomes.
We act as your EEG consultant, helping to navigate the complexities with turnkey solutions. Staff have a combined 248 years of EEG experience, with academic medical center and clinical trial experience.
Vigilance monitoring is provided by U.S.- based registered EEG technologists who proactively view live video EEG to monitor quality and troubleshoot in real time. This ensures high quality subject data is technically acceptable to control subject acquisition costs.
Our Global Project Lead is a physician with 30+ years in clinical trials, 15 with EEG, to expertly provide study and protocol design.
Highly qualified neurologists act as Central Reviewers, providing consistent EEG interpretation and assisting in study eligibility to improve study protocol efficiency.
Central Reviewers can also provide adjudication services.
Compact and easy-to-use, Lifelines Neuro’s rugged hardware and advanced EEG technology are used by top research centers around the world. The cloud-based platform provides consistency at all sites.
Data security features include:
- Systems are located in redundant SOC2 compliant data centers.
- Data transmissions are secured with the HTTPS TLS 1.2 protocol.
- Data encryption at the AES-256 level, at rest and in transit.
- Cloud solution fulfills the requirements of CFR 21 Part 11.
- Software offers unique user accounts with password complexity and dual factor authentication enabled.
- Remote support is offered through an encrypted platform.
Synthesys Brain Health is an exciting collaboration bringing together class-leading EEG hardware and software from Lifelines Neuro with Neurovative Diagnostics EEG exceptional reading and monitoring services to extend the global reach of our Clinical Trials team.
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