Phase I to IV, guaranteed EMA/FDA compliance.
Small and mid-size pharma, biotechs, first-time sponsors. Interventional and observational studies, drugs and health products. CDISC standards on 100% of our studies, deliverables compliant with EMA and FDA.
Human-scale CRO: small and medium pharma/biotech organisations benefit from a single point of contact from protocol through CSR — without the overhead of a large CRO and without CDMS licence surcharges.
For sponsors, first-time or expert
From protocol design to the CSR, comprehensive expertise adapted to every regulatory stage — France and Europe.
Phase I to IV clinical trials
Protocol design, CPP/ANSM submission, multicentre setup, centralised monitoring, database lock. Full management of interventional studies in France and Europe.
Observational & real-world studies
Cohorts, registries, post-marketing studies. Longitudinal follow-up, patient ePRO, HDS hosting. Adapted to Phase IV studies and EMA post-marketing requirements.
Full biostatistics under SAS
Statistical analysis plan compliant with ICH E9, sample size calculation, centralised randomisation, interim analyses, TLF integrable into the CSR per ICH E3.
EMA / FDA compliance
CDISC SDTM & ADaM datasets, define.xml, reviewer's guide, MedDRA & WHO-Drug coding by certified coders, 21 CFR Part 11 audit trail. Turnkey international submissions.
Therapeutic areas covered
A pharma study to entrust?
First clinical trial, ongoing Phase I–II, or FDA submission in preparation — a senior team member will get back to you within 24 business hours with a methodological assessment.
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