Research planning and concept

What plans should be prepared before launching a clinical trial? What are bioequivalence studies? Contracts in Clinical Trials: Which Documents Govern Collaboration Between Parties? Patient Consent in Clinical Trials: Which Documents Does a Participant Sign? Can a medical facility become a clinical research site? Kick-off meeting in a clinical trial – what is it and why is it important? Visit and procedure schedule in a clinical trial – how to create it? The Foundation of an Effective Clinical Trial: How to Develop a Strong Study Concept Should every study have planned secondary and exploratory objectives? How to identify key study risks at an early stage and plan actions to minimize their impact? How do inclusion and exclusion criteria affect recruitment speed and study duration? How to properly plan inclusion and exclusion criteria in a study? How to identify which of them may pose the greatest challenges and how to address them? How long does it usually take to develop the concept of a clinical or observational study and its protocol? How to best plan the key study endpoints? How to define a realistic study timeline before starting project activities? If I only have an idea, can a CRO help me design the study and develop the protocol? At what stage of planning a clinical trial should a CRO be involved? What are the best practices for developing a study protocol? How many patients should we include in our study? How do operational requirements differ between commercial and non-commercial studies?