A CRO with over 20 years’ experience, compliant with standards (ICH, CDISC, etc.) and regulatory requirements (France’s Jardé law on research studies in humans, etc.)
Working with life sciences stakeholders, from the writing of protocols to the publication of scientific articles
PHARMA LABS – BIO/MEDTECHs – MD/IVD – COSMETICS – NUTRITION – VETERINARY
Phase II to IV studies
Transversal or longitudinal studies
Cohort studies, registries
Observatories, Post-MA studies
Develop and demonstrate the reliability of an automated measurement system for a diagnostic evaluation test for a disease.
Set up and lead a PMCF (post marketing clinical follow-up) and patient recurrence evaluation study.
Develop a clinical evaluation strategy for the CE marking of an image-processing algorithm.
Develop and apply a statistical (propensity score) and medical analysis method for a non-randomized study.
Determine the dose-response relationship and dosage to be used during a subsequent study phase for comparing the drug to placebo.
Set up and lead a prospective, multicenter phase IV clinical trial.