With the aim of promoting and improving the effectiveness of the services of the Andalusian Foundation for Progress and Health (FPS), belonging to the Ministry of Health and Consumer Affairs, is awarded to Soltel the analysis, evolutionary development and implementation of Biomedical Research Ethics Portal in Andalusia (PEIBA).

The FPS assigns the PEIBA project to Soltel

As a premise to this information, the current system used by the Public Foundation for Progress and Health presents several operational problems and technical dependencies, which hinder its management and use by users. It is for this reason that the FPS seeks to obtain a new information system that meets current and future requirements.

With regard to the above, the project initiative PEIBA, of utmost importance to the region, is awarded to SoltelThis portal requires the improvement of several strategic processes for the benefit of the Andalusian Foundation for Progress and Health, as well as the Optimizing the biomedical research process to ensure compliance with the highest technical, ethical, and regulatory standards.

Some objectives of this award

As to specific objectives, the PEIBA project defines the adaptation of the system to the required regulatory changes, evolving it so that it integrates with the electronic administration platforms of the Junta de Andalucía (in accordance with Law 39/2015) and developing a system that favors all biomedical research studies carried out in Andalusia.

On the other hand, in the context of operational objectivesOur company will process the authorization required by Order SAS/3470/2009, will handle the authorization process by the Autonomous Communities for carrying out biomedical research involving any invasive procedure, will guarantee electronic communication with the Administration (in accordance with Law 39/2015) and will adapt the system to the data protection regulations (GDPR).

Scope of service

Among a wide variety of planned functions, we highlight that the system will allow the record of all biomedical research studies that are to be carried out on human beings in centers in Andalusia, except those managed by the clinical trials portal of the AEMPS; the management of the communication of its beginning or the communication of its beginning with a request for a report from the CEi/CElm, for studies that require it (communication-request); the management of the rest of the communications or communication-requests that may be presented during the execution of the study as a result of the modification of the conditions of the study; the management of the expiry file that may be initiated for studies whose completion or withdrawal is not communicated; and the recording of tracking information that it is mandatory to record during the study and its control by the CElm.

What is the Biomedical Research Ethics Portal in Andalusia (PEIBA)?

The PEIBA It is the Integrated Information and Management System for Research Studies in Andalusia, which stands as the main channel for requesting ethical opinions in the region.

This innovative initiative, a pioneer in Spain, provides researchers, promoters, organizations, and authorized individuals with the opportunity to have their project evaluated, and to be able to download the corresponding ethical opinion quickly. simplifying the process and promoting transparency in biomedical research.

With this project, Soltel will significantly optimize the biomedical research process in Andalusia, ensuring compliance with the highest ethical and regulatory standards, and thus contributing to the scientific and health advancement of the region.

The system is already in production.

As has been shown throughout this article, the work carried out by Soltel is fundamental to Strengthen integrity and transparency in biomedical research in the region. Our commitment to technical excellence will allow this organization to move towards a future where public health and the well-being of Andalusian society are enhanced through a rigorous research process.

As of the date of publication of this article, The service has been in production since the beginning of the year; a service that will undoubtedly leave a significant mark on the promotion of ethics and scientific advancement in Andalusia.