Case Study #2

A biotechnology company with a novel product entered the clinic looking to manage a limited budget and generate initial data. The goal was to conduct a battery of supporting clinical trials using outsourced providers for their experience, flexibility, and cost effectiveness.

The company received proposals from full-service CRO companies. The proposed budgets included many caveats allowing for cost adjustments and increases if extra work was needed. The CRO companies reviewed the protocols but did not present more cost effective ways to execute the program.

The FSMO was engaged to meet with the sponsor so it could better understand the requirements of the clinical trial. The FSMO then identified execution strategies and presented the appropriate FSPs for the requirements. The FSPs were selected to manage four data sources for consolidation and centralization of information. Data needed to be readily available to many team members, including data safety review boards, safety monitoring team, senior leaders, and study team members. The study was adaptive in nature and uniquely designed to use fewer patients and help lower study costs. This execution strategy created challenges for the larger CRO companies to support.

The FSMO provided a team leader with over 26 years of industry and global FSP management experience to coordinate the services of data collection, medical imaging, central lab integration biostatistics, and reporting across many fronts.

Additionally the FSPs selected for the project agreed to a fixed-price contract arrangement that saved the sponsor 40% of the expected full-service CRO costs.

During the trial execution, a number of changes that impacted the eCRF pages were submitted and were identified as necessary. The date for training and deployment was only days away. The team gathered to discuss a strategy and identified a way to adjust its own workflow to include changes in other work, postpone noncritical pieces, and meet the deadline required for the study initiation. Because of adjustments in the workflow, the project scope—and the original contract costs—did not change.