Forecasting and capacity planning: anticipating the regulatory workload 90 days out
Builds a 90-day rolling forecast from known deadlines, seasonal patterns, and pipeline intelligence, applies capacity planning to match projected workload against available resources, and evaluates the forecast as a management communication instrument.
The RC who never gets surprised
There is a particular kind of regulatory coordinator who seems to navigate every quarter without crisis. Continuing reviews are submitted early. Start-up timelines are met. Amendments flow through the system without last-minute scrambles. Their team appears less stressed than teams at comparable sites. Their sponsors and CRAs consistently rate the site as organized and responsive.
The temptation is to attribute this to talent, or to a lighter workload. In my experience, neither explanation holds. These RCs manage the same number of studies, face the same external pressures, and encounter the same kinds of deadline collisions described in Lesson 2. What they possess that reactive RCs do not is a forward-looking view of the portfolio -- a forecast that shows them what is coming 90 days before it arrives.
Course 1 introduced the idea that portfolio management requires looking ahead rather than merely responding to what is in front of you. This lesson teaches the specific methodology. You will learn to build a 90-day rolling forecast, match projected workload against available resources, identify periods where demand will exceed capacity, and take preemptive action while the calendar still has room for intervention.
The shift from reactive to proactive is not a personality trait. It is an infrastructure decision.
What you will learn
By the end of this lesson, you will be able to: