Implementing a Global CTMS to Improve the Quality of Clinical Trials
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