The first quarter sets the tone for the entire year. It’s the point where priorities are defined, oversight models are tested, and execution either builds momentum—or holds you back. Yet many Sponsors enter January already in recovery mode, working through unresolved issues instead of advancing projects efficiently. The result is lost time early in the year that’s difficult to make up later.
When approached intentionally, Q1 is about creating clarity of objectives, establishing reliable controls, and positioning talented teams for stronger execution and bigger success for the balance of the year.
A slow start in Q1 often carries more risk than expected. Early delays can snowball quickly –—missed decisions, unclear ownership, and inconsistent oversight create downstream inefficiencies that most times affect timelines which then affects budgets. Teams operating reactively spend more time addressing issues after impact is felt, rather than preventing them in the first place. Establishing control early allows sponsors to shift from reactive execution to proactive oversight before trial activity accelerates.
Operational clarity is the foundation of a strong Q1 start. This begins with confirming governance structures and oversight cadence so expectations are unambiguous. Roles, responsibilities, and escalation pathways should be aligned early to prevent confusion as studies progress. Clear expectations and defined QC approaches further support consistency across teams, minimizing the need for corrective action later in the year.
When these elements are in place, teams gain confidence in how decisions are made, how issues are surfaced, and how risks are managed—creating a more stable and predictable operating environment as study activity increases.
Establishing clarity is only the first step. Once operational foundations are in place, sponsors can turn attention to one of the most critical drivers of trial risk: inspection readiness. In Part II, we’ll explore how early TMF health checks, proactive identification of documentation gaps, and timely compliance assessments reduce regulatory risk—long before urgency sets in.
