The services listed below are available for access regardless of the call for proposals and research topic you select in your pre-application form.
Regulatory oversight & advice
Assessment of regulatory requirement for marketing authorization
Scientific advice for preparing an application to the European Medicines Agency
Informal scientific advice with selected national competent authorities, for highly complex projects
Pre-clinical and clinical development plan development – Target Product Profile (TPP) and Investigational Medicinal Product Dossier (IMPD)
Regulatory requirements for trial authorization and subsequent amendments by competent authorities and ethics committees, fast track procedures, coordinated authorization
Protocol design For clinical trials
Support for clinical trial methodology, selection of trial design, endpoints and core outcome measures
Planning For clinical trials
Planning of clinical trial operations, including regulatory / ethical requirements, informed consent, data monitoring plan data management plan, data sharing plan.
Support for developing the main outlines of funding application including grant proposal
Advise on strategies for site selection and patient recruitment
Funding mechanisms available including support for preparation of trial budget
Task distribution for multinational study management
Access to ongoing platform trials for new therapeutic, prevention or vaccine intervention arms (Only for SARS-COV-2/COVID-19)
This service offers to conduct clinical trials as new intervention arms in one of the three EU-funded adaptive platform trials (including operational management services such as regulatory/ethical submission of protocol amendments, IMP management, pharmacovigilance, data management, monitoring):
Adaptative platform trials available:
REMAP‑COVID (also known as REMAP-CAP), an international platform trial for CAP (community acquired pneumonia) initiated in 2014 and rapidly expanded to include COVID-19 patients. Several domains of this trial are exclusive for patients with confirmed or suspected COVID-19.
EU‑SolidAct a pan-European adaptive platform trial involved with rapid and coordinated investigation of new and repurposed medications to treat Covid-19 in hospitalized patients.
