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A Paradigm Shift for Clinical Trials – Risk Based Monitoring Change Management
Project Overview
Project Overview
Designing and executing a comprehensive Learning and Communications framework to drive enterprise-wide adoption of Risk Based Monitoring.
A leading global pharmaceutical organization sought to revolutionize its clinical trial operations by implementing Risk Based Monitoring (RBM) across a diverse and demanding development pipeline. This innovative methodology leverages risk-based principles to elevate study quality and patient safety, strategically allocating resources where they generate maximum value. The initiative represents a TransCelerate cross-industry collaboration.
Our Solution
Our Solution
Afiniti spearheaded the Communications and Learning workstreams to accelerate RBM adoption throughout the organization’s global Product Development and Medical Affairs functions, unlocking the full potential of risk-based clinical trial management.
Throughout the engagement, Afiniti:
Orchestrated an integrated learning and communications framework that reinforced the core value proposition of RBM across all learning channels
Established a distinctive visual identity that conveyed a compelling RBM narrative, resonating with stakeholders in the most affected roles
Architected a communications strategy to ensure consistent messaging and impactful visuals through digital and in-person channels reaching a worldwide audience
Executed a targeted campaign for critical roles within the Study Management Team to deliver tailored, role-relevant messaging
Implemented cutting-edge, participant-driven learning interventions grounded in Reflective Learning principles, incorporating diverse formats including Immersive Simulations, eLearning modules, Quick Reference Guides, MOOCs, and Learning Path Assessments
Rolled out an intuitive RBM portal, dynamic videos, and interactive global roadshows to facilitate RBM implementation
The Differences We Made
The Differences We Made
Directed end-to-end delivery of learning and communications by coordinating planning across benefits, change, communications & learning workstreams with transparent reporting to the client PMO
Produced communication assets designed for long-term sustainability as the transformation becomes embedded in operations
Developed knowledgeable and motivated study teams prepared to embrace the transition
Garnered outstanding employee feedback
Achieved quantifiable learning outcomes – over 90% completion rate for required learning programs
The Client Perspective
“The work has led to a well thought through process and tools which teams are now starting to see the benefit of, with a very robust training and change management plan and great communication tools to help us change the mind-set.”
Head of Country Clinical Operations
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