Kappa Santé
European contract research organization providing clinical development, real-world evidence (RWE) / HEOR, and medical device clinical investigation services across Western, Southern and Central Europe. Services include study design and start-up, multi-country trial execution, regulatory and ethics submissions (including CTIS/EU CTR), data management and biostatistics, pharmacovigilance, medical writing and publication support, and RWE generation with data sourcing and governance. The organization operates under a unified Quality Management System aligned to international standards and emphasizes senior-led teams and accountable project ownership.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Strategic planning and protocol development for interventional and observational clinical studies.
Feasibility assessments, site selection and study start-up activities across European countries.
Preparation and submission of regulatory and ethics dossiers for European clinical studies.
Program and project management, integrated stakeholder coordination, operational oversight and accountable delivery across study lifecycle.
Clinical data capture, database management, statistical analysis and RWD analytics.
Monitoring (on-site/remote), medical monitoring and pharmacovigilance support.
Strategic planning and protocol development for interventional and observational clinical studies.
Feasibility assessments, site selection and study start-up activities across European countries.
Preparation and submission of regulatory and ethics dossiers for European clinical studies.
Program and project management, integrated stakeholder coordination, operational oversight and accountable delivery across study lifecycle.
Clinical data capture, database management, statistical analysis and RWD analytics.
Monitoring (on-site/remote), medical monitoring and pharmacovigilance support.
Expertise Areas
- Clinical trial management
- Real-world evidence (RWE) and HEOR
- Regulatory compliance (EU CTR/CTIS, IVDR, MHRA)
- Biostatistics and clinical data management
Key Technologies
- CTIS / EU Clinical Trials Regulation (CTR) submissions
- IVDR and companion diagnostic regulatory pathways
- GDPR-compliant data protection and cross-border transfer mechanisms
- Real-world data (RWD) sourcing and analytics
News & Updates
Article reviewing ATMP clinical development challenges, regulatory updates and CRO selection considerations.
Guide describing how clinical trials are conducted in Spain, covering the regulatory environment, ethics review, site infrastructure and advantages of Spain as a research destination.
Guide explaining conduct of clinical trials in France, including regulatory framework, ethics review process and site infrastructure.
Article exploring differences between Western and Eastern Europe for clinical trial selection and the impact of CTIS/CTR.
Article describing current RWE/HEOR use cases, evidence generation changes, and AI governance considerations.
Recognition for sustainability practices and alignment of emissions reduction strategy with global climate science (EcoVadis, SBTi) and CDP reporting.
Article reviewing ATMP clinical development challenges, regulatory updates and CRO selection considerations.
Guide describing how clinical trials are conducted in Spain, covering the regulatory environment, ethics review, site infrastructure and advantages of Spain as a research destination.
Guide explaining conduct of clinical trials in France, including regulatory framework, ethics review process and site infrastructure.
Article exploring differences between Western and Eastern Europe for clinical trial selection and the impact of CTIS/CTR.
Article describing current RWE/HEOR use cases, evidence generation changes, and AI governance considerations.
Recognition for sustainability practices and alignment of emissions reduction strategy with global climate science (EcoVadis, SBTi) and CDP reporting.