SynapCell's Expertise in Preclinical EEG
All tests are performed using EEG in vivo, in freely-moving and clinically-relevant rodent models of brain diseases.
Our EEG Biomarker approach can be used to objectively determine the potential pharmacodynamic efficacy of compounds tested, based on resting state EEG profiles, event-related (ERP, ASSR) or pharmaco-induced EEG Biomarkers.
Our EEG-based Cue® platform is the smart combination of a team of skilled neuroscientists, clinically-relevant rodent models, high-end recording techniques and proprietary signal processing.
Our pharmacodynamic assays use the robustness and translational power of EEG for:
- Lead selection (screening of small libraries of compounds)
- Lead validation (dose-response effects, pharmacodynamic effects, kinetic studies)
- Measurement of disease-modifying or neuroprotective potential
- Assessment of anti-epileptogenic or anti-epileptic effects (using non-convulsive animal models)
- Model phenotyping
- EEG Biomarker development and identification
- Program De-risking (pro-epileptic, seizure aggravating effect)
- Dose optimization, dose ranging
- Acute or chronic protocols
- Clinical-like, crossover designs
- Exploratory EEG programs, designed to help you shape your experiment from A to Z.
We are a fully integrated company, with our own animal and research facilities. As a French organization, the animal facility is certified by the French Ministry of Research and the Veterinary Services. Our high-level security system ensures access to the platform is restricted to authorized personnel only. Since 2017, our 4310-square-foot facility has the capacity to house over 400 animals. See Quality & Animal Welfare section for more details.
We apply the Three R’s (Replacement, Reduction, Refinement) to all our activities. In addition, all protocols are submitted for approval by an Ethics Committee. To support both internal and external R&D programs for our clients, we have developed three cutting-edge in-house platforms for Neurosurgery, EEG/ERP recording, and advanced signal analysis. As a result, all experimental stages are performed internally for optimum project efficiency, traceability, quality assurance, and cost optimization.
Cue® is SynapCell’s translational and predictive in vivo EEG Platform. The name Cue® originates from the letter “Q”, standing for Quantitative. It is also a inspired by the term from music, a domain that is actually closer to EEG than we might initially think. SynapCell’s core technology is capable of cueing specific electrical waves (biomarkers) from neuronal networks similarly to musicians extracting the best samples from a song.
Project Management
Maintaining close contact with the Sponsor is essential for both parties to agree on all milestones and deliverables for the study. This is done for each client from project initiation to completion, at every individual step. Your main contacts will be our Business Development team for the commercial and legal steps, our Head of Science for protocol and study design, and the Head of Operations for project coordination and reporting.
Once the commercial and legal steps have been completed, and the agreement between SynapCell and the Sponsor on the study details has been signed, the project is ready for launch. Depending on the nature of the study, it will be started within an average of 2 to 3 weeks, as soon as a planning slot is available.
On average, the first data become available between 3 and 6 weeks after the launch of a new study; the final report is generally produced within 11 to 15 weeks if the Sponsor’s compound is received on schedule. For example, for a full dose-response assessment of an anti-epileptic compound on the SynapCell MTLE mouse, model generation takes 7 weeks (Epileptogenesis phase), and compound testing takes 4 to 5 additional weeks.
We are committed to providing Sponsors with proactive feedback throughout the study. The Head of Operations maintains continuous contact with the Sponsor to organize logistics (e.g. compound shipment) or receive any necessary information for successful project management. At each important milestone during a study, a meeting with the Sponsor is arranged to update them on the latest results.
We do not conduct Toxicity or Safety Studies per se. Our offer is focused on preclinical efficacy studies that are performed exclusively in vivo on freely-moving animal models. However, the GAERS model can be used as a derisking model to identify seizure-aggravationg or pro-epileptic effects for any compound. Spike-and-Wave Discharges (SWD) could therefore be used as a safety EEG biomarker. In addition, we pay particular attention to animal welfare throughout our studies. If any potential toxic effect is observed, we immediately warn the Sponsor so that action can be taken.
Quality Assurance & Animal Welfare
Studies are managed starting with a study proposal followed by full study design. All animal procedures are carried out in accordance with the guidelines handed down in the European Community’s Council Directive 2010/63/EU on animal protection and welfare. Moreover, all processes, including animal welfare and experimental procedures, are documented in our Quality Management System.
All staff members involved in sponsored studies are accredited to perform animal experimentation and have several years of experience in neuroscience, pharmacology, surgery, signal recording or processing. Half of our team are PhD-holders, and everyone at SynapCell performing experiments is enrolled in a continuous training program certified by the French Ministry of Agriculture. Training programs may be internal or external.
All of our lab activities are carried out according to a set of Standard Operating Procedures (SOP) that are documented in our Quality Management System and made available to our customers on request. Efficacy testing does not require GLP compliance; however, our procedures do align with the OECD principles of Good Laboratory Practice [C(97)186/Final], ensuring rigorous Quality Assurance within the lab.
As you know, our experiments, exclusively in vivo, are carried out on translational models. All procedures comply with EU guidelines for the welfare and use of animals in research and are approved by an independent ethics committee, simplifying project initiation.
All studies are performed according to SynapCell’s local Standard Operating Procedures (SOP), inspired by the OCDE rules of Good Laboratory Practices [C(97)186/Final]. Even if preclinical efficacy studies are not required to be GLP compliant, SynapCell is aligned with the OCDE principles of GLP and applies its rules.
We are committed to protecting the confidentiality of your studies and data. Your studies are carried out by our people in a secure environment designed to safeguard your project data and other information.
We have implemented strict access control policies to protect our facilities, computer systems and files, and sensitive data.
IT security at SynapCell consists in protecting the company’s computer systems from theft or damage to hardware, software or information, as well as from disruption or misdirection of the services provided.
Security measures taken include controlling physical access to the hardware, as well as protecting against incidenys linked to network access, data and code injection.
According to these measures, Sponsor information is managed by 3 levels of security:
- Physical security: restricted access to the building, requiring a magnetic badge identifying SynapCell employees.
- Daily Backup: workstations are backed up to a central server once a day, and additional backups to a dedicated remote server are run nightly over the Internet.
- Information access: any incident or failure is automatically over-ridden thanks to a SPARE drive system.
In addition, all team members involved with the Sponsor’s project are committed to full confidentiality.
To find out more about our capabilities and how we can collaborate, please contact us
Quality Management at SynapCell
Let's Talk About Your Research Project!
More than a CRO, a team of collaborators – we are your neuroscience dream team specialized in preclinical EEG! We don’t just produce data; we’re your partners from concept to conclusion. We translate raw EEG data into meaningful and clinically relevant endpoints, delivering clear insights leading to data-based decisions. Choose SynapCell for cutting-edge science with an irresistible touch of fun!