Hospital Clínico Universitario de Santiago de Compostela (CHUS) is the main Hospital in Galicia. It manages at present more than 100 research projects funded through competitive calls, more than 600 clinical trials as well as numerous collaborations with industry. CHUS is part of Servicio Galego de Saude (SERGAS), which is an autonomous administrative body responsible for the management and provision of health services in the Public National Health Care system in the Region of Galicia (Population: 2,772,533) working with a total budget of 3,788 M €. It includes a network of 14 hospitals of which 3 of them are university hospitals, 457 primary health care centres and more than 37,000 workers (7,314 physicians). Biomedical research and development is one of the most important activities of the SRG which in 2019 resulted in 2,000 biomedical publications. Fundación Instituto de Investigación Sanitaria de Santiago (FIDIS) is a non-profit entity and will provide, during the whole execution of the project, managerial and administrative services to SERGAS as a third party.
We lead WP1 (Clinical Network & Biobanking) and WP2 (Data Management). Concerning WP1, our main tasks are: (i) to maintain and organise the clinical network linking hospitals in Europe and partners in Gambia, Nepal and Taiwan; (ii) to consolidate, maintain, organise and administer the biobank, and to ensure that the biobanking process is undertaken within ethical, legal and social acceptability frameworks; and (iii) to organise the acquisition of RNA samples with matched clinical data of patients with infectious and inflammatory conditions through a combination of prospective recruitment and sample retrieval from existing collections; including vulnerable populations (pregnant women, neonate).Within WP2, we are in charge, together with our partners at Imperial for: (i) development of the Consortium Data Management Plan; (ii) assessment of cloud providers; (iii) development of electronic storage for case report form; (iv) storage of high-throughput gene expression data; and (v) storage and curation of intermediate data, results, and methods. The data team will ensure all important results, code, methods, and conclusions generated throughout the project duration is properly curated and disseminated. We also contribute in WP4 (Cross platform validation of PMSD transcripts), WP5 (Contribute to bioinformatic data-analysis), WP7 (contribute to development of virtual patients), and WP8 (pilot implementation study site).
Expertise on: 1) all tasks related to clinical studies preparation, design, regulatory, management and performance as well as recruitment of patients when necessary; 2) on genomics, transcriptomics and bioinformatics; and 3) on vaccines and infectious diseases. We jointly provide the clinical expertise of Translational Pediatrics and Infectious Diseases Unit (2018 and 2019 national award to the best ID unit) and Genetics, Vaccines, Infections and Pediatrics research group (GENVIP) (2019 Zendal research award), specialised in paediatric infectious diseases and clinical trials. GENVIP has extensive collaborative experience in big scale multi-centre studies related to infectious diseases and “omics”. GENVIP coordinates several international clinical consortia and it is involved in 8 EU-funded projects, namely, PERFORM (GA 668303), PoC-ID (GA 634415), PREPARE (GA 602525), EUCLIDS (GA 279185), Connect-4-children (GA 777389), ZIKACTION (GA 734857) and RESCEU project (GA 116019-3). GENVIP has a world-class Clinical Trial Unit and coordinates RECLIP, the Spanish clinical trials network. GENVIP laboratory has all the necessary infrastructures related to cell cultures, including specific area to work in sterile and biosecure conditions equipped with laminar flow cabinets, CO2 incubators and cell counters systems; as well as a cryostorage area. GENVIP also has a nanostring n-counter platform available, that allows direct directly analysis of hundreds of mRNAs, miRNAs, SNV, CNV or proteins through a molecular digital measurement in a single tube and in absence of any enzymatic reaction (no amplification or retro-transcription is needed). A high sensibility and reproducibility technology with a high multiplexing capability (up to 800 genes in a single reaction).
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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 848196