The honest answer, the one most training programs avoid, is that you cannot do everything. Not because you lack effort or competence, but because the regulatory operations of a multi-study portfolio are constrained by resources that have hard limits. The principal investigator is available 12 hours per week for research. The IRB meets once per month and has a submission capacity ceiling. You have 40 hours in a week, possibly 45 if you are disciplined about boundaries, and your assistant has another 30. That is the supply side. And when the timeline shows four continuing reviews, one protocol amendment, and a new study activation converging in the same three-week window, the demand side exceeds supply by a factor you cannot close with longer hours.

This is not a crisis management problem. Crisis management is reactive -- it is the art of damage control after things have gone wrong. What I want to teach you here is something fundamentally different: proactive system design. The regulatory coordinator who builds a resource allocation framework before the peak-load period arrives does not experience a crisis. She experiences a busy three weeks with a plan. The one who does not build that framework discovers, too late, that willpower and overtime are not substitutes for structural preparation.

ICH E6(R3), Annex 1, Section 2.2.2, requires that adequate staff be available to conduct the trial. That requirement is not merely about headcount. It is about capacity -- the right skills, at the right time, applied to the right tasks. And capacity is meaningless without allocation.

The honest answer, the one most training programs avoid, is that you cannot do everything. Not because you lack effort or competence, but because the regulatory operations of a multi-study portfolio are constrained by resources that have hard limits. The principal investigator is available 12 hours per week for research. The IRB meets once per month and has a submission capacity ceiling. You have 40 hours in a week, possibly 45 if you are disciplined about boundaries, and your assistant has another 30. That is the supply side. And when the timeline shows four continuing reviews, one protocol amendment, and a new study activation converging in the same three-week window, the demand side exceeds supply by a factor you cannot close with longer hours.

This is not a crisis management problem. Crisis management is reactive -- it is the art of damage control after things have gone wrong. What I want to teach you here is something fundamentally different: proactive system design. The regulatory coordinator who builds a resource allocation framework before the peak-load period arrives does not experience a crisis. She experiences a busy three weeks with a plan. The one who does not build that framework discovers, too late, that willpower and overtime are not substitutes for structural preparation.

ICH E6(R3), Annex 1, Section 2.2.2, requires that adequate staff be available to conduct the trial. That requirement is not merely about headcount. It is about capacity -- the right skills, at the right time, applied to the right tasks. And capacity is meaningless without allocation.