At León Research, we provide comprehensive solutions as a Contract Research Organization (CRO), covering all phases of clinical development.
• Year of foundation: 2007
• Number of employees: 48
• Alfonso García Cañamaque
o CEO
o Email: agarcia@leonresearch.com
• Héctor Urdiales Fernández
o Marketing Manager
o Email: hurdiales@leonresearch.com
Our team supports sponsors and manufacturers in the design, initiation and monitoring of clinical trials and research studies, ensuring a strategic and regulatory approach from the very beginning.
We manage all the processes required to bring a new medicinal product or medical device to market, including medical writing, data management and support during the regulatory submission process. In addition, we ensure an effective pharmacovigilance system both during study development and after marketing authorization, complying with the highest standards of safety and quality.
We also offer auditing services, either for investigational sites or complete studies, with the aim of ensuring proper conduct and preparing all documentation to successfully face any inspection or external audit. Furthermore, we act as Legal Representatives for clinical trials in the European Union, facilitating regulatory compliance for sponsors not established in the region.
Our services, in detail:
- Design and planning of clinical trials
- Site selection
- Regulatory Affairs-CTIS
- Contract Negotiation
- Monitoring
- Data Management and biostatistics
- Pharmacovigilance and Medical Device Vigilance Services
- Clinical Auditing
- Legal Representation in EU
-Archive
- Warehouse
We have a direct presence in Spain, Italy and Portugal, and operate internationally through AICROS, a European network of CROs that allows us to provide global coverage while maintaining high standards of proximity, efficiency and local expertise.
With a vision focused on quality, transparency and operational excellence, León Research is committed to being a reliable partner in the development of safe and effective medicines and medical devices.
