Foundation for Cardiovascular Research and Education
A European clinical research organization focused on investigator-initiated and real‑world trials in cardiovascular medicine. FCRE coordinates multicenter studies across high‑volume vascular centers, provides protocol development, electronic data collection support, post‑market clinical follow‑up (PMCF) for medical devices, regulatory support for device development and early‑phase trials, and offers clinical trial project management and medical writing services.
Industries
Nr. of Employees
small (1-50)
Foundation for Cardiovascular Research and Education
Services
Design and execution of investigator‑initiated, randomized and real‑world clinical studies in cardiovascular medicine.
Execution of follow‑up studies to collect post‑market clinical data for CE‑marked devices in accordance with MDR requirements.
Advisory support for regulatory strategy, dossier preparation and planning of early‑phase clinical trials.
Support for electronic data collection and clinical data handling for studies.
Preparation of clinical and regulatory documentation and implementation of quality processes for studies.
Provision of clinical project managers, clinical research associates and trial assistants for study operations.
Design and execution of investigator‑initiated, randomized and real‑world clinical studies in cardiovascular medicine.
Execution of follow‑up studies to collect post‑market clinical data for CE‑marked devices in accordance with MDR requirements.
Advisory support for regulatory strategy, dossier preparation and planning of early‑phase clinical trials.
Support for electronic data collection and clinical data handling for studies.
Preparation of clinical and regulatory documentation and implementation of quality processes for studies.
Provision of clinical project managers, clinical research associates and trial assistants for study operations.
Expertise Areas
- Clinical trial management
- Investigator‑initiated and real‑world trials
- Post‑market clinical follow‑up (PMCF) and MDR compliance
- Endovascular and vascular device clinical studies
Key Technologies
- Electronic data capture (EDC)
- Real‑world evidence study methods
- Randomized controlled trial methodology
- Post‑market surveillance / PMCF
News & Updates
List of ongoing cardiovascular device studies coordinated or supported by the foundation, including studies on stent grafts, bioresorbable scaffolds, and randomized comparisons of endovascular approaches.
List of ongoing cardiovascular device studies coordinated or supported by the foundation, including studies on stent grafts, bioresorbable scaffolds, and randomized comparisons of endovascular approaches.