Client Challenge

A global pharmaceutical company headquartered in Japan faced the challenge of implementing its first global clinical trial management system (CTMS) and associated new business processes for both internally- and CRO-managed clinical studies.

Stakeholders spread across 3 continents and 14 functional areas with requirements unique to each region meant that unifying systems, standards, and processes would be intensive and complex. Managing the implementation with the company’s minimal available resources would introduce an unnecessary level of risk to this critical and highly visible project.

Red Nucleus Solution

Red Nucleus provided experienced project management for the implementation effort. This included creation and management of project schedule and timeline, management and coordination of the cross-functional business team, IT vendor management, oversight of validation and training activities, risk management/mitigation planning, and custom sponsor dashboarding and reporting.


The Red Nucleus project management team, applying internal and industry best practices, drove the diverse group to an on-time implementation of their CTMS. This also resulted in global standardization of clinical milestones, definitions and processes, and gave a newfound visibility into study performance while allowing internal leadership streamlined visibility and oversight of project management activities.