We offer project management and coordination to ensure all legislative and regulatory obligations of the sponsor related to the planning, preparation, implementation and evaluation of clinical trials of drugs, diagnostic methods or medical devices in the field of rare diseases - comprehensive and partial services:

• Preparation and completion of the necessary documentation for the assessment of the study by regulatory authorities
• Submission of documentation and study processing through the European Clinical Trials Portal (CTIS)
• Expert management of the study and project team to ensure all required activities are carried out in accordance with GCP
• Coordination of study centres within a multicentre study