Clinical operations
Framing, feasibility, coordination, milestone tracking, risk anticipation and recovery of complex projects.
Observational studies, RWE & epidemiology
Scientific and operational structuring of non-interventional studies, registries, secondary data studies and real-world approaches.
Health data governance
Mapping of data flows, responsibilities, documentation, minimisation, security and consistency between scientific needs and GDPR.
GDPR, CNIL & compliance
Support for reference methodologies, DPIAs, DPAs, records, transfers, processors and compliance documentation.
Scientific & regulatory documentation
Protocols, framing notes, procedures, operational supports, responsibility matrices and ready-to-use documentation.
Sponsor, CRO & vendor coordination
Pragmatic interface between scientific, operational, quality, IT, DPO, vendor and decision-making stakeholders.
Processes, SOPs & quality
Critical review, simplification, documentary consistency and alignment with applicable real-life practices.
Rescue & operational remediation
Rapid diagnosis, prioritisation, issue correction and proportionate action plans to secure project continuation.