Non-GLP preclinical studies

As part of its services, SILABE offers to conduct on-site scientific studies on behalf of public or private research teams.

The site provides, both logistically and scientifically, for the conduct of non-GLP studies in the fields of pharmacology (proof of concept, pharmacokinetics or pharmacodynamics), gene therapy or for the validation of surgical protocols.

The activities undertaken by the platform include validating and scientifically justifying the chosen model, designing and optimising the protocol, drafting referrals or other requests for regulatory authorisations, ethical assessment of the protocols requested, conducting the experimental protocols, analysis of the data obtained and producing final written reports.

In practice, carrying out experimental studies on site requires the approval of a competent ethics committee and project authorisation issued by the Ministry of Higher Education and Research via the web-based platform APAFIS. Project authorisation requests are written by our scientific project leaders, who ensure that the use of non-human primates is relevant and well-founded, that it complies with current ethical regulations, and that the principle of the 3Rs is applied.

Through internal audits, SILABE’s internal animal welfare body (SBEA) ensures project compliance and, more specifically, compliance with the procedures set and validated by the ethics committee and the Ministry of Research. The SBAE also provides users with advice and participates in retrospective evaluations of research projects, a mandatory step for any study conducted on non-human primates.

In addition, a scientific and strategic council, composed of external members and experts in the field of animal research, supervises and validates all projects carried out at SILABE, ensuring that the ethical regulations set by the University of Strasbourg are met.



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