Clinical Trials Management (CRO)
As a Contract Research Organization (CRO), we provide all the necessary services for the conduct of clinical trials with medical products, ranging from obtaining the relevant permits and authorizations to initiation and monitoring
Clinical trials management and monitoring.
With the new REGULATION (EU) 2017/745, clinical research on Medical Devices has undergone a significant change and update. Companies intending to market their Medical Devices in the European Union will need to have updated clinical data on the performance and clinical safety of their product, for which in many cases, they will be requiredd to generate clinical data through clinical studies.
A clinical study, from its planning phase to the final report with results, interpretation, and conclusions, undergoes many situations and actions that require decision-making, some easy and some not so easy. There are several key moments in the clinical trial such as writing the protocol, selecting investigators, recruiting patients, closing the database, and understanding the results in the statistical report.
Conducting a clinical trial is full of challenges and unforeseen events. There is legislation and national and international guidelines that must be followed and applied, making it more complex and specialized.
At CARJES SOLUCIONES, our team includes personnel who are specialized in the management and monitoring of clinical trials, in accordance with the requirements outlined in Articles 62 to 82 of Regulation (EU) 2017/745 and its Annex XV, as well as the standard EN ISO 14155:2020 for clinical investigations of medical devices.
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Consultancy specialized in medical devicess, biocides and food and nutritional supplements.
C/ Puerto de los Leones 2, Planta 2. Oficina 12. 28220. Majadahonda. Madrid.
