PReSTaR offers comprehensive support for academic studies and clinical trials through a wide range of activities. One of its main objectives is to support the development and management of international disease registries, with a specific focus on rare conditions and the aim of improving patient care and enabling evidence-based policymaking.
Operationally, in the regulatory domain, it provides formal and administrative guidance in drafting study protocols and informed consent forms, support sites in local ethics committee or CTIS approval processes. From an administrative and scientific standpoint , PReSTaR assists in drafting Case Report Forms (CRFs), manages periodic reporting and Trial Master Files, and supports Data and Safety Monitoring Boards. It coordinates logistics, including shipment of biological materials or drugs, maintains communication tools such as mailing lists and newsletters, and aids in grant applications and publication processes.
PReSTaR also supports data collection and web system development by creating eCRF, automating scoring tools, and managing data quality, surveys, and coding. Additionally, PReSTaR contributes in the financial aspects of trials, including budget development and negotiation, reviewing and stipulation of agreements with sites, payment, and support in the preparation of budgets for public/private grants.