Regulatory Advice, Trial Preparation & Advice on Planning and Design of Clinical Trials

• 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

• Support for clinical trial methodology, selection of trial design, endpoints and core outcome measures

• Planning of clinical trial operations, including regulatory / ethical requirements, informed consent, data monitoring plan, data management and data sharing plan
• Supporting the development of the main aspects of funding applications including grant proposals and preparation of trial budget
• Support in identifying available funding mechanisms
• Advice on strategies for site selection and patient recruitment
• Task distribution for multinational study management
  Open access tools (www.ecrin.org/tools)
  

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):

• 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.
• VACCELERATE (European Corona Vaccine Trial Accelerator Platform), will accelerate phase 2 & 3 COVID-19 vaccine trials.