Scientific/Technical Advice
Support and scientific advice in the design of studies and drafting of research protocols to ensure the best scientific and technical standards. ensure the best scientific and technical standards.
Provide scientific-regulatory advice in a way that harmonises scientific and regulatory requirements in order to achieve rapid and efficient requirements are harmonised in order to achieve rapid and efficient authorisation of diagnostic and therapeutic and therapeutic aids and medical devices if necessary.
Clinical Operations Development
In order to support independent clinical research, the platform has a multidisciplinary team that enables the following activities to be carried out both nationally and internationally:
- Design and methodology
- Start-up and dealings with regulatory affairs.
- Coordination of studies and monitoring
- Data management and statistics
- Pharmacovigilance
- Scientific writing
Scope of action
In general terms, and always within the field of independent clinical research, SCReN directs its activities to carry out multicentre projects with a high impact on the National Health System:
- Clinical trials on medicinal products or medical devices (phases I-IV)
- Studies with medicinal product or medical device with other non-clinical trial designs
- Clinical trials with other non-drug interventions (e.g. surgical interventions)
- Observational studies with/without drug
Scope
SCReN in Spain
SCReN was created within the framework of the Strategic Action on Health of the 2013 calls for proposals, with the aim to objective of:
- To provide high-level scientific, technical and technological support to R&D&I projects in Health Sciences and Technologies, especially to integrated projects of excellence in Health Sciences and Technologies, especially to the integrated projects of excellence of the IIS accredited HRIs. Promote transversal projects within its area of action.
- Promote Spanish participation in international programmes and platforms.
- Promote innovation in health technologies as an instrument that contributes to the sustainability of the NHS. sustainability of the NHS. It continues its development with the AES 2017 plan and is currently supported by the AES 2020 call.
It is financed by the Instituto de Salud Carlos III and the European Regional Development Funds (ERDF).
SCReN in Europe
At the European level, SCReN is part of the ECRIN (European Clinical Research Infraestructure) which is the support and management body for independent multinational clinical trials. ECRIN is a not-for-profit organisation, and connects the national networks of clinical research networks, advising on and implementing the relevant EU legislation with the support of its members. Currently, 13 of the 28 countries of the European Union form part of the ECRIN and this number is expected to increase. Of these 13, 12 are member states with participation and 1 is an observer.
Global Situation
Since its inception, the platform has supported both national and international studies. It currently has 220 projects of which 30 are ECRIN projects. Below is a graph of the number of projects that have been incorporated into the platform, we show you a graph on the number of projects that have been incorporated annually:
| Year | Projects |
|---|---|
| 2013 | 19 |
| 2014 | 12 |
| 2015 | 15 |
| 2016 | 28 |
| 2017 | 31 |
| 2018 | 14 |
| 2019 | 18 |
| 2020 | 25 |
| 2021 | 41 |
| 2022 | 14 |