Services portfolio

Beginning with the design and proposal, continuing with the development and ending with the results and their possible dissemination, SCReN puts a variety of services at your disposal that are tailored to the needs of your clinical research project.

• Design, start-up and regulatory management

  In SCReN we count on a team of methodologists who provide advice on the planning and design of phase I to phase III studies, post-authorization studies and observational studies. In addition, support is offered in stages as early as the review of scientific reports for public Calls for funding, to which the project may be eligible.

  Our start-up services cover every need, from the selection of centres and investigators, the protocol draft and supporting documents, the processing of administrative authorizations with the Clinical Research Ethics Committees (CEICs), the Autonomous Communities, and the Spanish Agency of Medicines and Medical Devices (AEMPS) and the management of insurance policies and contracts with the centres, through to the creation and management of dossiers and master files.

  In addition, SCReN has considerable experience in dealing with regulatory requirements and pharmacovigilance tasks as required at the start of the study, during its development and upon its completion. These include activities such as the registration and evaluation of adverse events, the notification of SUSARs, the processing and submission of periodic safety reports, the start and end of study notifications, and the preparation and submission of annual and final reports.

• Global monitoring and coordination

  In SCReN we perform global monitoring and coordination of clinical trials, both nationally and internationally (through ECRIN, or other collaborators...).

  In order to monitor the progress of the study and ensure compliance with the protocol and GCPs, our monitors implement a risk-based monitoring system. This includes both visits in person at the site (initiation, monitoring, closure) and remote reviews of the data, as well as fluid communication with the research team in each participating site. At the same time, we apply recruitment incentive measures and regularly send out newsletters, hold conference calls and make motivational visits.

• Data management and statistical analysis

  Our professional team performs all the activities required to ensure the quality of the data management. We collaborate in the design of the CRFs and the creation and validation of the databases, the management and coding of AEs and SAEs, as well as the validation of all clinical data. We also provide essential support in the preparation of statistical plans and the randomization proposal, as well as in drafting specific sections of the protocol (calculation of the sample size and statistical power), and in carrying out the statistical analysis and the necessary reports.

• Assistance in manufacturing, management and distribution of the IMP

  SCReN has extensive experience in the supply of Investigational Medicinal Products (IMPs) thanks to the collaboration of the Pharmacy Services of the Hospital Virgen del Rocío. Thus, we offer support in managing the supply of the IMP including: the application processes for manufacture or import; total or partial manufacture (repackaging, masking or relabelling for clinical trials) of drugs and placebo; storage and safeguarding of drugs and placebo; preparation of orders and distribution to participating sites; and returns and/or destruction of the study medicinal products.

• Analytical services and complementary studies

  Additionally, due to the professionals and the integrated resources in the biomedical research institutes, SCReN is able to offer support in the development of pharmacokinetic, pharmacogenomic, and pharmacoeconomic studies, so as to complement and enhance the value of clinical trials that are proposed.

• Medical and Scientific Communication

  In SCReN, we also offer support in the preparation and drafting of all kinds of reports and dissemination elements of the results or procedures of the clinical trials, ranging from the development of clinical reports and medical publications (abstracts, posters, etc.) to writing protocols, articles or expert reports.

• Quality Control

  In SCReN, we care for the quality of our services and encourage the continual training of our employees, the frequent review and update of the Standard Operating Procedures, and the in-depth audits in the field of Good Clinical Practices and Quality Assurance Systems.

Areas of activity

The priority studies for the Spanish Platform for Clinical Trials are:

• Clinical trials with medicinal products.
• Clinical trials with medical devices.

When applicable, the relevance of including other types of projects that fit into the procedures and objectives of the platform will be assessed. These could include experimental studies about different interventions of medicinal products or medical devices and studies about medicinal products, different interventions of medicinal products or medical devices of alternative designs to that of the clinical trial, provided they are:

• Research projects promoted by scientific societies or scientific groups.
• Research projects evaluated positively in competitive Calls for funding with public funds.
• Research projects that pose situations in which the experimental design is not feasible and there is a reasoned scientific uncertainty about the effectiveness and safety of medicinal products in the postauthorization period and under conditions of clinical practice.
• Research projects that pose situations where there is a high probability of problems of use with the medicinal products, and these problems of use influence the effectiveness and safety of the medicinal products and have a high impact on the health system.