FundeSalud participation in clinical trials
In the area of the Autonomous Community of Extremadura Fundesalud promotes relations between the Promoter, the Principal Investigator and the Extremadura Health Service subscription Contracts clinical trials with medicines and medical devices under Decree 57/2010, of March 5th. It also participates in the signing of contracts assuming the economic and administrative management of the funds for conducting clinical trials of drugs and medical devices.
Management Unit Clinical Trials Extremadura
Dedicated exclusively to the management of all activities related to clinical research, the Management Unit Clinical Trials Extremadura has among its main objectives promote translational clinical research, through a solid structure of support to researchers; encourage interaction and coordination between the different services of hospitals and research groups in order to promote new research projects with the highest possible quality and speed in their management; Translational boost clinical research projects and provide technical and administrative support to all research groups; clinical trials and attract industry to contribute to the promotion of clinical research in Extremadura, ensuring quick and quality management, an effective recruitment according to the study objectives and visibility to the transfer of results. Management Unit Clinical Trials is headquartered in the town of Mérida and has two offices that support the two provinces of the region.
Solicitation of Clinical Trial
Under current legislation the trial sponsor, or CRO represent you, you must sign a contract with FundeSalud and Extremadura Health Service following the procedure laid down in Article 4 of Decree 57/2010, whose Annexes I and II collect Models type Contract Clinical Trial Drug and Clinical Trial Agreement with Health Products respectively. Once properly completed the contract, or for any questions about it, you must send it to the address investigacionclinica@fundesalud.es
Links of interest
Clinical research with medical devices
FUNDESALUD C/ Pio Baroja Num 10 06800 Mérida Tel: +34 924 009309 Fax: +34 924 009304
