Lifelines for Pharmaceutical Trials and Research
EEG solutions with real-time support for pharmaceuticals, therapeutic devices, and other research trials.
Lifelines Neurodiagnostic Systems delivers proven experience supporting pharmaceuticals, therapeutic
devices, and other research trials around the globe. With extensive neurodiagnostics experience, a dedicated support staff, and widespread access to physicians and EEG technologists, Lifelines is a respected partner of pharmaceutical researchers world-wide.
Our established, turnkey, cloud-based EEG solution, iEEG Acquire, helps clinical researchers gain real-time access to data from anywhere in the world. By incorporating iEEG Acquire into studies, contract research organizations (CROs) and pharma research teams benefit from enhanced efficiency, decreased cost, improved accuracy, and more effective outcomes.
Our solution is founded on four main pillars: Technology, Global Support, Vigilance, and Logistics.
- Compact and easy-to-use, Lifelines’ rugged hardware leverages advanced EEG technology and has been used by top research centers around the world.
- Our cloud-based platform provides consistency at all sites.
- The ability to scale rapidly as FDA requirements change, including increased number of sites, protocol shifts due to FDA negotiations, and/or altered or expanded deadlines provides cost efficiencies.
- All equipment and software meet HIPAA, FDA, and CE requirements, while providing real-time data (EEG and video) through the cloud.
- The highest Advanced Encryption Standard (AES), 256-bit encryption of data is in place, end-to-end. This is the same level of encryption used by the US Government for highly classified information.
- Detailed, customizable reporting of all clinical data is provided. There are full audit capabilities for each individual user throughout the entire scope of the trial.
- Our technology is capable of exporting data in nonproprietary data formats, which expands the ability to broaden the analysis of the clinical data.
- Collaboration is also available for neuro biomarker development with specialization in epilepsy, dementia, early-onset Alzheimer's, and ADHD.
- The technical pharma support team is comprised of Registered EEG and Certified Long Term Monitoring technologists (R. EEG T./CLTM). This level of expertise ensures the recordings are technically acceptable for the success of the study protocol.
- Our team includes experienced physicians, who have completed multiple CNS trials, to provide study and protocol design. This proven experience saves trial time and costs.
- In addition to consistent EEG interpretation, our highly qualified, esteemed Central Reviewers can assist in situations regarding study eligibility. This will improve efficiency in the study protocol.
- Training is available onsite or can be given remotely to the trial site. Group training at investigator meetings controls training costs.
- 24/7, remote, real-time vigilance monitoring is given for all trial sites.
- Our support 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.
- vEEG data is transmitted to the cloud, monitored live, and made available for Central Review in real-time.
- Quality control checks from our support team ensure data is correctly blinded from the trial sites, prior to assignment to Central Review, meeting FDA guidelines to who sees what data, where, and when.
- Our experienced logistics team controls shipments to trial sites around the world. We effectively and efficiently navigate the complex network of shipping documents including: Proforma (commercial) invoices, FCC forms, import licenses, customs regulations, and possibly the need for a power-of-attorney for the receiving broker in each country. Keeping the shipment schedule in control saves time, so that a ‘domino effect’ does not occur, causing lengthy delays and increased costs for the clinical trial.