The Challenge

A site organization engaged our team for assistance with budget forecasting and protocol development. The client struggled to develop fair market value budgets that accurately captured all required operational tasks. Furthermore, while the site had established study protocols capable of accelerating sponsor objectives, varying sponsor requirements resulted in frequent protocol amendments, creating operational delays and friction.

The Solution

We performed a thorough evaluation of the site's financial and protocol management processes, implementing a structured two-pronged strategy:

• Tailored Budgeting Framework: Developed a customizable budget template that ensured comprehensive task coverage and alignment with fair market value standards during sponsor negotiations.

• Master Protocol Architecture: Revised their original protocol to make it broader to accommodate a wide range of sponsors, and developed a master protocol that allowed standard procedures to remain consistent while enabling sponsor-specific needs to be integrated seamlessly via modular sub-protocols.

The Outcome

The new master protocol architecture allowed the site organization to efficiently execute study programs across multiple sponsors simultaneously without requiring disruptive protocol amendments. Additionally, the standardized budgeting tools streamlined client negotiations and improved cost recovery across all research activities.