Methods


Clinical pharmacology studies from first in man to proof of concept studies: single, multiple dose tolerance, interaction studies, pk, special population

Phases II, III to mega-trials: traditional as well as innovative designs allowing optimisation, including adaptive and bayesian designs

Multiple outcomes, Time-to-event endpoints

Multivariate normal regression models, Generalised linear modelling

Medico-economic evaluation

Pharmaco-epidemiology, registries, meta-analysis, analysis of multidimensional data

Topics


Infectious diseases

Immunology Vaccine Research

Geriatric, Neuro-degenerative diseases

Rare diseases

Medical devices, Imaging studies

Nutrition

Cancer

Resource-limited settings

Trial Management


Site selection and monitoring, project management

ISO norm certification, CIC GCP

Biobank


Biobank facility (CRB) Bordeaux

Data Management


ECRIN Data Management Centre,eCRF (Clinsight, Macro) and database design (production and set-up), data-validation and cleaning

Multidimensional data – very large databases (ca. 300,000 patients, 10,000,000+ observations),omics data

Subcontracting


Theradis and LC2 (management of IMP, Accelence and Kappa Santé (CROs)
CATI, NeuroSpin, Pasteur Institute Lille, Saclay (Neuroimaging); CIC-IT Nancy (Imaging)

Dissemination - reporting


Support for grant applications

Report writing and co-writing of publications

Vigilance, Safety


Local department, renowned nationally and internationally