Regulatory Submission
The final protocol and site list are submitted to regulatory bodies like the FDA or EMA for approval. A well-documented feasibility analysis provides a strong justification for the study design, patient population, and site selection. It demonstrates to regulators that the trial is well-planned, viable, and has a high likelihood of success, which can lead to a smoother and faster review process.
Compiling the complete submission package for IRBs and regulatory authorities.
Writing a clear justification for the study design, patient population, and site selection based on feasibility data.
Preparing to respond to questions from regulatory bodies regarding trial viability.
Submitting incomplete or poorly organized documentation can cause significant delays.
A poorly justified protocol may face heavy scrutiny and requests for modification.
Navigating the different regulatory requirements for multinational trials.
Access key guidelines from the FDA and EMA to ensure your trial design meets regulatory standards.
Review Industry Resources