54 Resource & Capacity Planning
54.1 Purpose
Resource planning ensures that the trial has sufficient human capacity to execute planned activities.
In clinical trials, resources are primarily: - CRAs - CTMs - data managers - safety staff - vendors
54.2 CRA Capacity
CRA workload is driven by: - number of sites - visit frequency - complexity - risk level
Overloaded CRAs lead to: - missed visits - delayed follow-up - quality issues - burnout
54.3 Site Load
Sites differ in: - enrollment volume - data quality - deviation rate - support needs
High-burden sites require: - increased monitoring - more communication - escalation readiness
54.4 Vendor Oversight
External vendors include: - CROs - labs - imaging vendors - EDC providers
PM must monitor: - performance metrics - deliverable timelines - contract obligations
Vendors are resources, not black boxes.
54.5 Scaling and Reallocation
Resource plans must adapt to: - new sites - delayed enrollment - emerging risks - staff turnover
PM’s role is to: - anticipate overload, - redistribute work, - and prevent systemic failure.
54.6 Resource Planning as Risk Management
In practice, most trial failures result from: > insufficient or misaligned resources.
Resource planning is therefore a primary risk control activity.