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Case study
Phase III Oncology: Rescue of a Delayed Global Clinical Trial 

A multinational biopharmaceutical company initiated a global Phase III clinical development program for a novel anti-tumor agent, evaluated as a second- or third-line treatment for metastatic solid tumors. The global recruitment target was 500 patients, with study sites across the United States, Europe, and Asia-Pacific. 

Following delayed site start-up and slow patient recruitment under a global CRO, APICES was engaged to take over regional clinical operations for 28 sites across Spain, France, Italy, and Portugal. 

The Challenge

The study was already behind schedule when APICES assumed responsibility, leaving no room for further delays. A CRO transition mid-study added operational complexity and risk. In parallel, the sponsor aimed to position itself as a preferred partner for investigators across participating countries — an objective that had not been achieved under the previous model. 

Delayed site activation and underperforming recruitment
Mid-study CRO transition under fixed global timelines
Weak investigator engagement and site ownership
High CRA turnover and limited flexibility from the global CRO

The APICES Approach

APICES implemented a focused rescue strategy, combining operational speed with strong local investigator relationships.

Key elements of the approach included:

  • Rapid alignment with the sponsor, investigators, and global CRO to ensure a seamless transition
  • Reselection and activation of high-performing oncology sites, including centers not initially considered
  • Direct, face-to-face engagement with investigators to remove operational barriers and re-energize recruitment
  • Centralized start-up and monitoring led by APICES’ in-house clinical operations team in Spain
  • Deployment of a stable, experienced oncology CRA team to ensure continuity and ownership

This hands-on, locally driven approach restored momentum and control of the study. Despite starting significantly behind other countries, APICES rapidly improved performance and delivered measurable results. The sponsor recognized APICES’ contribution as instrumental in bringing the study back on track and strengthening relationships with key investigators across Southern Europe. 

Spain became the 3rd highest recruiting country globally
Approximately 10% of total global patients recruited
Recruitment rate increased from less than 1 patient per month to an average of 3 patients per month
Critical development milestones achieved and study timelines stabilized

The sponsor recognized APICES’ contribution as instrumental in bringing the study back on track and strengthening relationships with key investigators across Southern Europe.