Beatriz Caballero Sanchez

As a full-service Contract Research Organization, our solutions include all the activities from design, setting up and monitoring of clinical trials and research studies, up to the management of data, statistical analysis, and medical writing, covering the whole process to introduce new medical devices and pharmacy products on the market.

Among the services that León Research offers we should highlight everything related to the setting up of clinical trials that refers to the development and review of protocols for trials, preparation of documentation adapted to the local law, obtaining the necessary approvals by the CEICs/IRBs and regulatory international to national authorities, the design and elaboration of case report forms, biostatistics and determination of the sample size, selection of the best sites and investigators, negotiation of site and investigators contract, and everything required to set up a study.

Another relevant aspect of the service we provide as a CRO is the development of the study including the monitoring and follow-up of the trial, the support on maintenance of the necessary documentation, selection visits, start up, follow up, audits and close out visits, and completion of the trial. In association with this services we include the medical writing and statistical analysis, as well as the management of the files generated during the study with a dynamic or permanent storage service for the generated documentation, aimed at not only the documentation of the studies for which the sponsor is responsible but also the documentation of the sites, researchers and other CROs.

Finally, in order to provide the best services to our clients, it´s very important to create a specific safety system to be followed to reduce the risks and increase the benefits of investigation medicinal products during the studies. Therefore, we provide a high-quality Pharmacovigilance Service during each study by creating a specific plan for the safety system to be followed to each study adapted to the Good Pharmacovigilance Practice Guidelines included on the EU Legal Framework. We offer as well, local representative QPPV(Qualified Person for Pharmacovigilance) in the countries that we work in: Spain, Italy, and Portugal.