Design and implementation of the study

What Is Interim Analysis (IA) and What Challenges Does It Involve? What Is the Difference Between a Submission and a Notification in a Clinical Trial? What Types of Research Sites Participate in Clinical Trials? Data management in a clinical trial – how to ensure data quality at every stage? Patient recruitment in a clinical trial – proven practices that help meet the target on time Selection of research sites in a clinical trial – who is responsible and how to do it effectively? How long does the start-up phase of a clinical trial last in Poland? Realistic timelines and factors affecting the project start. How to effectively plan the number and type of monitoring visits in a clinical trial? The role of interim analysis in managing study safety and efficacy When and how should protocol amendments be implemented, and what are the consequences? How to monitor patient recruitment and verify recruitment plans? What are the roles and responsibilities of the Sponsor, CRO, and research site during study conduct? What are the criteria for selecting and qualifying research sites? How to effectively plan the patient recruitment process? What are the main risk factors affecting a study timeline? How do we minimise operational risks and prevent delays? Can a CRO identify study sites for a clinical trial? Why is feasibility so important? Can the CRO include international sites?