Patrick Legendre Email and Phone Number

BIO-INOVA / EUROFINS MEDINET Central Labs:Set-up and follow-up of international studies (phase I to IV) in various therapeutic areas (alcohol addiction, auto-immune diseases, cardiology, CNS, coagulation, microbiology, oncology…).Sponsors (pharmaceutical lab, start-up and CRO): AP-HP, Bayer, Cerexa, Durata, INC, Ipsen, Merck, Orion, Premier, PSI, Sanofi, Servier, Unilever etc..Tasks: Supervision of junior PM. Preparation of slides and presentations for bid-defence, kick-off and investigator meetings. Set-up of the SOW with the promoter. Design of the lab-kits and request forms for identification of the biological samples (bar-coded labels). Evaluation of the logistics for the shipment of lab-kits to the investigator sites (5 continents) and the shipment of biological samples back to the Central Lab for analysis.Writing of the Investigator Laboratory Manual: Procedures and guidelines to be respected (GCP / GLP) for sampling (blood, urine, stools, biopsies, bacterial or viral strains etc..): Type and order of the collection tubes to be sampled, centrifugation, aliquoting, labelling, ambient or frozen shipment (stability of the biological parameters) etc.. as well as rules for packing the UN3373 biological samples (IATA and customs regulations) and request for pick-up by international carriers.Internal coordination of the different services of the Central Lab (manufacturing and dispatch of the sampling lab-kits, reception and sorting of the biological samples, analytical labs (routine safety haematology and biochemistry analyses, PK/PD or esoteric analyses / CLIA validation) and data-management. Participation to the priming of the information systems for entry of the biological samples in the databases and LIMS connected to the automated analysers and freezers for prolonged storage and for the alert report to the investigators in case of critical lab value.

Clinical Monitoring for BIO-INOVA (March 1997 - Feb. 2002):CRA for the follow-up of 3 clinical trials related to nephrology and haemodialysis (1-Boehringer Mannheim Laboratory / Recopen study / Device for self-injection of calibrated quantities of erythropoietin) and oncology (2-Boehringer Mannheim / Ibandronate study / hypercalcemia in metastatic patient and 3-Hoechst Laboratory / Anandron 2000 study / prostate cancer at an early stage).Initiation visits: Presentation of the trial (CRF, medical devices and lab-kits etc..) to the medical team and collection of signatures for the administrative documents (TMF).Follow-up and close-out visits: QC check and correction of the CRF on site versus the source documentation (patient hospital file with lab reports and interpretation of medical imaging print-outs and scans etc..). Management of the patients consent and the distribution of treatment units as well as adverse events.NEGMA Laboratory (Nov. 1995 - June 1996): Initiation to clinical monitoring (co-monitoring) in the context of 3 trials (phases I, III and IV) for the same anti-arthrosis molecule (Diacérhéine).