Tina Jukich, VP and General Manager Clinical Trials: “Our team is dedicated to providing critical guidance and support from trial design to execution. This includes expert consultation in EEG and provision of original hardware, software, secure storage, staffing, customized workflow, cloud-capable safety monitoring, centralized reader access, and standardized reporting, as well as analyses to inform and de-risk clinical research.”
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. By bringing together Neurovative Diagnostics services and Lifelines Neuro’s hardware and software solutions, Synthesys can deliver end-to-end clinical trial oversight and execution with a dedicated team of registered EEG technologists.
Neurovative Diagnostics
Our internal EEG expertise can help you de-risk your trial with early consultation.
All technologists are qualified and highly skilled (technical and adaptive).
Our EEG technologists are experienced in pediatric as well as adult EEG.
They can be posted to participant homes, clinics, hospitals, and clinical trials sites.
By ensuring abnormalities associated with seizures are systematically identified and confirmed prior to compound exposure.
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.
By ensuring that the criteria are standardized in the interpretation of EEGs, leading to more consistent readings across the subject population.
By providing a structured process for resolving differences in interpretation leading to more reliable results.
By demonstrating rigorous processes are in place to address safety concerns.
Lifelines Neuro’s rugged hardware and cloud-based platform leverages advanced EEG technology and has been used by top research centers around the world. All equipment and software meets HIPAA, FDA, CE, and GDPR requirements. All clinical data has 256-bit encryption, with customizable reporting and full audit capabilities.
Our Vigilance Monitoring Team proactively views the live, video EEG (vEEG) from around the globe to monitor the quality of the recording and troubleshoot in real-time. This ensures subject data is of the highest quality and will be technically acceptable for the study, controlling subject acquisition costs.
Experienced physicians provide study and protocol design, saving trial time and costs. Registered EEG and Certified Long Term Monitoring technologists nsure recordings meet the study protocol requirements. Highly qualified Central Reviewers help to ensure consistent EEG interpretation and study eligibility. Training is available onsite or remotely for individuals or groups.
Our experienced logistics team controls shipments to trial sites around the world. We effectively and efficiently navigate the complex network of shipping documents including: Commercial invoices, FCC forms, import licenses, customs regulations, and, sometimes, the power-of-attorney for the receiving broker in each country.
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