The Clinical Research Unit in Pharmacology and Toxicology (RCPT), located within the Department of Pharmacology, Toxicology, and Pharmacovigilance at the University Hospital of Limoges (CHU de Limoges), serves as a support structure for UMR-1248 Pharmacology & Transplantation.
It coordinates clinical studies sponsored by CHU de Limoges and INSERM, working closely with other units within the department (Biological Pharmacology and Pharmacokinetics, Pharmacometrics and Artificial Intelligence, and Environmental Toxicology and Occupational Health) as well as clinical departments involved in the projects (notably Nephrology, Dialysis and Transplantation, and Hepato-Gastroenterology and Nutrition). These studies primarily focus on immunosuppressive drugs, used in transplantation as well as in other conditions such as autoimmune diseases and cancer

Caroline Monchaud
Project Manager
The RCPT Clinical Research Unit supports members of UMR1248 in designing clinical research projects, collaborating with the sponsor throughout the entire process—from the initial research idea to its valorization. This includes: securing funding, literature review, formulating research hypotheses, regulatory compliance, drafting clinical research protocols, coordinating participating centers, managing biological samples, conducting pharmacology and toxicology analyses, data management, statistical analyses and pharmacokinetic modeling, preparing final study reports, presenting findings at conferences and publishing in scientific journals.
The RCPT Unit establishes and manages biological collections related to the research themes of UMR1248. It is a member of CRBioLim (Biological Resource Center of CHU Limoges) and is responsible for preserving biological resources (biological samples and associated data recorded in specialized software) in accordance with current standards. Its key focus areas include: “biomarkers in transplantation”, “autoimmune diseases”, “oncology biomarkers” and “biomarkers of response to anti-infective treatments”.
The RCPT Unit’s activities comply with Good Clinical Practices (GCP) and current regulations. Additionally, it collaborates closely with INSERM UMR1248 research and CRBioLim operations for biological sample management.
Consequently, RCPT’s activities align with the laboratory’s quality systems, which are accredited under the ISO 15189 medical biology standard and certified under the ISO 20387 biobank standard (CRBioLim).
Some examples
Marquet, P., Destère, A., Monchaud, C. et al. Clinical Pharmacokinetics and Bayesian Estimators for the Individual Dose Adjustment of a Generic Formulation of Tacrolimus in Adult Kidney Transplant Recipients. Clin Pharmacokinet 60, 611–622 (2021). https://doi.org/10.1007/s40262-020-00959-y
Monchaud C, Woillard JB, Crépin S, et al. Tacrolimus Exposure Before and After a Switch From Twice-Daily Immediate-Release to Once-Daily Prolonged Release Tacrolimus: The ENVARSWITCH Study. Transpl Int. 2023 Aug 1;36:11366. doi: 10.3389/ti.2023.11366
Premiers recrutements prévus à l’automne 2024
Premiers recrutements prévus à l’automne 2024