Scientific/Technical Advisory
Support and scientific advice in the design of studies and drafting of research protocols that ensure the highest scientific and technical standards.
Provide scientific-regulatory advice to harmonize scientific and regulatory requirements in order to efficiently and quickly obtain authorization for diagnostic and therapeutic means and medical devices if necessary.
Clinical Operations Development
With the aim of supporting independent clinical research, the platform has a multidisciplinary team that enables the following activities both nationally and internationally:
- Design and methodology
- Start-up and regulatory affairs procedures
- Study coordination 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 focuses its activities on conducting multicenter projects with high impact on the National Health System:
- Clinical trials with drugs or medical devices (phases I–IV)
- Studies with drugs or medical devices using designs other than clinical trials
- Clinical trials with interventions other than drugs (e.g., surgical interventions)
- Observational studies with/without drugs
Reach
SCReN in Spain
SCReN was created within the framework of the Strategic Action in Health from the 2013 calls, with the aim of:
- Providing high-level scientific, technical, and technological support to R&D&I projects in Health Sciences and Technologies, especially to integrated excellence projects from accredited IIS. Promoting cross-cutting projects within its area of activity.
- Boosting Spanish participation in international programs and platforms.
- Promoting innovation in health technologies as a tool to contribute to the sustainability of the NHS. Its development continued with the AES 2017 plan and is currently supported by the AES 2020 call.
It is funded 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 ECRIN (European Clinical Research Infrastructure), which is the body for support and management of independent multinational clinical trials. ECRIN is a non-profit organization that connects national clinical research networks, providing advice and applying current legislation in the European Union with the backing of its members. Currently, 13 of the 28 EU countries are part of ECRIN, and the number is expected to increase. Of these 13, 12 are full member states and 1 is an observer.
Global Situation
Since its inception, the platform has supported both national and international studies. Currently, it has 220 projects, 30 of which are part of ECRIN. Below is a graph showing the number of projects incorporated each year:
| Year | Projects |
|---|---|
| 2013 | 19 |
| 2014 | 12 |
| 2015 | 15 |
| 2016 | 28 |
| 2017 | 31 |
| 2018 | 14 |
| 2019 | 18 |
| 2020 | 25 |
| 2021 | 41 |
| 2022 | 14 |