Manage Out of Scope

Unmanageable Out-of-Scope

A mid-sized pharmaceutical company was developing a new oncology treatment. They partnered with a well-regarded CRO to manage the clinical trials. However, as the trials progressed, they encountered significant challenges with managing out-of-scope work and excessive change orders. Each time the CRO submitted a change order, it led to unexpected costs and extended timelines, overwhelming their internal procurement and project management teams. With over 20 change orders in just six months, the company struggled to track the changes, assess their validity, and maintain accurate budget forecasts. The complexity of the clinical trial and the constant back-and-forth with the CRO created inefficiencies and uncertainty. Communication gaps and lack of transparency made it nearly impossible for the company’s team to assess whether the changes were justified. They lacked real-time insight into how these changes impacted the overall trial budget, timelines, and resource allocation, which eventually delayed the project and raised operational costs by nearly 25%. This constant uncertainty and lack of control over the study’s financial management became a major bottleneck in the development process.

LEAD Automates Change Tracking

To regain control, they implemented Clinical Maestro’s SOURCE and LEAD systems. SOURCE helped streamline the RFP process, allowing them to evaluate CRO proposals with full transparency on scope, effort, and cost assumptions. With LEAD they were able to track study progress and manage change orders with precision. The automated system gave the company real-time insights into each change order, letting them evaluate the financial and operational impact before approvals. The forecasting and budgeting tools enabled the team to anticipate out-of-scope changes earlier, preventing surprises and avoiding unnecessary budget increases. Additionally, the earned value analysis allowed them to assess where the trial was relative to cost, timeline, and deliverables, ensuring they maintained control over the project.

Reduced Overruns and Timelines

With Clinical Maestro SOURCE and LEAD, the biopharma reduced out-of-scope change orders by 60%, allowing for better project and financial control. Budget overruns were reduced by 20%, and trial timelines shortened by nearly two months. The real-time visibility into project progress and costs improved communication with their CRO, reducing delays and ensuring that each change order was thoroughly vetted before approval. They regained confidence in their outsourcing process, achieving a more efficient and streamlined clinical trial.

Improved Efficiency with LEAD

Clinical Maestro’s SOURCE and LEAD systems transformed the company’s approach to managing out-of-scope work and change orders. By providing transparency, automation, and real-time insights, these tools enabled Phoenix to avoid costly surprises, improve operational efficiency, and accelerate their clinical trial timelines, setting them up for long-term success in their drug development efforts.