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.