Case Study: From Feasibility to Full Site Activation in Three Months for a Breast Cancer Trial
How centralized resources and coordinated startup execution helped Profound become the first site activated globally for a sponsor-priority oncology study
Accelerating clinical trial startup requires coordinated execution across multiple workstreams—from initial feasibility and site selection through contracting, site initiation, regulatory approval, and activation.
For one breast cancer clinical trial, the sponsor designated accelerated startup as a corporate priority.
Profound Research responded with a coordinated startup approach supported by centralized, dedicated resources. Over the next three months, the team moved through feasibility, site selection, contract and budget execution, the Site Initiation Visit (SIV), and regulatory and IRB approval.
The result: Profound moved from initial feasibility to Greenlight within three months and became the first site activated globally for the study.
The Challenge: Accelerated Startup for a Sponsor-Priority Oncology Study
From the beginning, the sponsor identified the breast cancer study as a corporate priority requiring accelerated startup.
Meeting that objective required efficient execution across each stage of the startup process. Feasibility, site selection, contracting, site initiation, regulatory review, and IRB approval all needed to progress within a compressed timeline.
The challenge was therefore not simply completing one startup milestone quickly. It was maintaining momentum across the entire process—from the initial feasibility request through full site activation.
The Solution: Centralized Resources and Coordinated Startup
Profound’s accelerated startup model is supported by centralized, dedicated resources focused on moving critical startup activities forward efficiently.
Following initial feasibility, the team progressed through the CRO and site selection process during the first month.
In the second month, site selection was completed and contract and budget activities moved through negotiation and execution.
By the third month, the team completed the SIV, regulatory requirements, and IRB approval necessary for site activation.
This coordinated approach helped maintain momentum across the critical startup milestones:
- Feasibility
- CTA and budget negotiation and execution
- Prompt SIV scheduling and completion
- Regulatory and IRB approval
By coordinating these activities across dedicated resources, Profound moved the study from initial feasibility through Greenlight within the sponsor’s accelerated timeline.
The Outcome: First Site Activated Globally
Within three months of initial feasibility, the site achieved Greenlight and became the first site activated globally for the study.
Key Study Achievements:
- Kickoff: Feasibility received
- Month One: CRO/site selection process
- Month Two: Site selection; contract and budget execution
- Month Three: SIV completed; regulatory and IRB approval secured; site activated
- Outcome: First site activated globally
The result demonstrates how coordinated startup execution and centralized resources can help compress the time required to move from initial feasibility through full site activation.
What This Means for Sponsors
Accelerated startup depends on maintaining momentum across the entire activation process.
A delay in contracting, site initiation, regulatory review, or IRB approval can affect the overall timeline even when other startup activities are progressing efficiently. Coordinating these workstreams through centralized, dedicated resources can help keep the process moving toward activation.
In this breast cancer trial, Profound progressed from initial feasibility through site selection, contract and budget execution, SIV completion, regulatory and IRB approval, and ultimately Greenlight within three months.
For sponsors and CROs managing priority oncology studies, the case demonstrates the value of an operational model designed to coordinate critical startup activities and move sites toward activation efficiently.
Looking Ahead
For sponsor-priority studies, speed to activation requires consistent execution from the earliest stages of feasibility through final regulatory approval.
In this breast cancer trial, Profound’s centralized resources and coordinated startup approach supported the site through each critical milestone—from feasibility and contracting to SIV completion and regulatory approval.
Within three months, the site achieved Greenlight and became the first site activated globally, demonstrating how a coordinated startup model can help sponsors bring priority oncology studies online quickly and efficiently.