Set-up of the study in Poland
MED-NET has professionally trained staff with many contacts with the research centers in different therapeutic areas. Company has its own database of the investigators and centers. Using this database and personal contacts it can perform feasibility studies and assess the possibilities to conduct the trial in Poland and in CEE countries.
All activities concerning study preparation can be performed as a preparation for single centre local study or as a part of multicentre international study:
• Investigator and site contract negotiations;
• Translation of the documents that need to be provided in local language;
• Modification of the study documents to meet Polish Regulatory requirements;
• Preparation of Investigator’s File;
• Organization of study materials import;
• Preparation of all materials that need to be provided to investigators;
• Organization of Investigator’s supply;
• Courier arrangements;
• Central or local laboratory arrangements;
• Organization of investigator’s meeting;
• Assisting investigators in obtaining Ethics Committee approval;
• Organization of country File.