Business Change Case Studies

A Paradigm Shift for Clinical Trials – Risk Based Monitoring

Project Overview

Project Overview

Creating and delivering an engaging Learning and Communications strategy to establish global adoption of Risk Based Monitoring.

To deliver a diverse and complex pipeline efficiently, this global Pharmaceutical company wanted to introduce Risk Based Monitoring (RBM) to the clinical trials process. This new approach advocates using risk-based principles to achieve greater study quality and patient safety focusing resources where they add most value. This is a TransCelerate cross-industry collaboration.

Our Solution

Our Solution

Afiniti led the Communications and Learning workstreams to maximise adoption of RBM within its global Product Development and Medical Affairs functions to realise the full benefits of a risk based approach to clinical trials.

Working on the project Afiniti:

  • Led a blended Learning and Communications approach reinforcing the ‘why RBM’ across all learning channel
  • Created a stand out visual identity to tell a strong RBM story, appealing to those roles most impacted
  • Developed a communications strategy to create consistent messaging and striking visuals combing online and face to face channels to reach a global audience
  • Launched a campaign focused on key roles in the Study Management Team to deliver role specific messages
  • Deployed innovative, user-led learning interventions based on Reflective Learning principles, using a range of media including Immersive Simulations, eLearning, Quick Reference Guides, MOOCs and Learning Path Assessments
  • Launched an intuitive RBM website, innovative videos and engaging global roadshows to support RBM deployment
The Differences We Made

The Differences We Made

  • Project managed delivery of Learning and Communications integrating planning across Benefits, Change, Comms & Learning workstreams and reporting into the client PMO
  • Delivered communication collateral with a focus on sustainability for continued use as the project embeds
  • Created informed and engaged study teams, ready to change
  • Received excellent employee feedback
  • Measurable learning approach – more than 90% have completed their required learning


“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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