SCReN
The Clinical Research and Clinical Trials Unit of the Institute of Biomedical Research of Salamanca (UICEC-IBSAL) is one of the IBSAL’s transversal research support platforms. It has been integrated in the Platform of Clinical Research Units and Clinical Trials of the ISCIII (SCReN) since 2013.
The Clinical Research and Clinical Trials Unit of the IBSAL offers its services to researchers interested in conducting clinical trials:
- Clinical trials with drugs or medical devices (phases I-IV)
- Drug or medical device studies with other than clinical trial designs
- Clinical trials with other non-drug interventions (i.e., surgical interventions).
- Observational studies with medication
The Clinical Research Unit provides initial methodological support in the organization of studies, from the classification and start-up of the study to its closure. The services offered are related to the management, regulation and monitoring of clinical trials, observational studies and research projects. These services can be divided into 4 blocks according to the phase of the study they support:
1.-
Pre-start of the study: methodological support that covers the needs of the project by providing methodological and design advice, as well as participating in the selection of centers and researchers, in the preparation of the initial documentation (protocol, information and consent forms, data collection notebooks, etc.).
2.-
Start-up: activities appropriate to each type of project and the applicable regulations, including tasks related to regulatory procedures, payment management, taking out liability insurance, contract management, preparation of master files, monitoring plans, etc.
3.-
Study development: project management and monitoring, communication with regulatory agencies, report writing, etc., providing full support to researchers and promoters for the proper conduct of the study with high quality standards and according to GCPs, in order to meet the deadlines set.
4.-
Completion and closure: maintenance of management and monitoring activities (closure visits, report writing, communication with regulatory agencies, etc.) to ensure that the study is completed within the required data quality and integrity standards and in compliance with applicable regulations.