Opening priority trials on a 45-day target

The Challenge

A leading academic medical center launched a rapid activation program for its highest-priority oncology trials. The goal was ambitious: move selected studies from intake to site activation within 45 days. Standard timelines at most institutions run significantly longer.

The complexity came from the number of independent approvals required. A single trial might need IRB (institutional review board) approval, radiation safety committee clearance, biosafety committee review, pharmacy sign-off, and lab certification. Each committee had its own meeting schedule, submission requirements, and review cycle. If any one of them ran late, the 45-day target was at risk. The program covered trials in Phase I, bone marrow transplant (BMT), genitourinary (GU) oncology, thoracic oncology, and neuro-oncology.

What We Did

We managed rapid-activation studies against the 45-day target. That started with building a clear picture of every milestone between intake and activation, then tracking each one proactively rather than reactively.

Our approach focused on parallel execution and early risk identification:

• Mapped the critical path for each study and identified which committee reviews could run in parallel rather than sequentially
• Ran pre-submission quality reviews on all regulatory packages before they went to the IRB or other committees, reducing the chance of questions or requests for additional information that would add review cycles
• Built workflows that standardized submission requirements across committees so study teams knew exactly what was needed and when
• Tracked milestone completion daily and flagged risks as soon as a timeline started to slip, not after it had already missed

We also trained regulatory coordinators on the rapid-activation process. Many coordinators were used to a more sequential workflow where each approval happened one at a time. We helped them shift to a parallel model where multiple submissions moved forward simultaneously.

When a submission hit an unexpected delay, we worked directly with the committee or department to understand the issue and find a path forward. Sometimes that meant providing additional documentation. Other times it meant connecting the right people to answer a question quickly.

The Result

High-priority trials moved through startup on an accelerated timeline. The 45-day target changed the expectation for how fast a trial could open, and the workflows we built made that expectation realistic rather than aspirational.

Activation became more predictable. Study teams and investigators could plan enrollment timelines with greater confidence because the startup process had clear milestones and known timelines for each stage. The regulatory coordinators we trained ran parallel submissions on their own studies after the program, which is the outcome that mattered most to the center: the speed did not depend on one person watching every milestone.