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Implementing a Global CTMS to Improve the Quality of Clinical Trials

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How do you account for and manage change for a very diverse and extensive list of stakeholders, many of whom are impacted differently?


The R&D division of a global Pharmaceutical company was faced with implementing a Clinical Trial Management System (CTMS) for a very diverse set of internal and external stakeholders.


A CTMS is an industry-standard yet no robust trial management system was in place for this rapidly growing organization. Only fragmented capabilities and processes existed. An end-to-end solution needed to be rolled out to busy study teams across regions and Clinical Research Organizations over a 6-month period.

Project Synopsis #3

What We Did:

  • Performed an extensive stakeholder analysis and revisited results throughout the project, keeping OCM plan flexible to account for new findings

  • Established a small but focused SME group to serve as Change Champions

  • Obsessively assessed and tracked stakeholder readiness

  • Created and executed a comprehensive stakeholder engagement and communication plan that addressed both individual stakeholder needs and broad organizational awareness


  • Uncovered and addressed impacts that were overlooked due to the variety of stakeholders involved, minimizing resistance

  • Generated high interest and excitement in the system’s potential, as evidenced by the growing number of studies added post-launch (total doubled within the first four months) and the number of new stakeholders inquiring about using or integrating their systems with the CTMS

  • Successfully moved stakeholders through the first major change (implementation) and working with a client on the second phase (integration with other systems)

  • Helped the team overcome limitations imposed by COVID-19 through more effective (and increased) uses of communication channels

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