Business Change Case Studies
Case Study

A Paradigm Shift for Clinical Trials – Risk Based Monitoring

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.

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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
  • 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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