Business Change Case Studies

Taking EU Clinical Trials Regulation Into The Future

Project Overview

Project Overview

The European Medicines Agency’s (EMA) EU Clinical Trials Regulation (CTR) came into effect in the EU/EEA on 31st January 2022, aiming to streamline the application and approval process. Non-compliance with CTR would result in serious penalties, and as such it was crucial for any company conducting clinical trials in the EU/EEA to follow the new regulation to avoid penalties and ensure patient safety. 

In early 2022, a global pharmaceutical and diagnostics company engaged Afiniti to enhance their organisational change management efforts for CTR and ensure change readiness for employees involved in the clinical trials in the EU/EEA. With a goal to empower the 4,000 impacted employees to effectively use technology, optimise processes and embrace mindset changes to meet these new legislative requirements, Afiniti developed a change and engagement strategy that would encourage teams to understand and adopt the new ways of working.

Our Solution

Our Solution

  • Supported a diverse network of 17 change champions (“CTR Core Connectors”) who could reach a dispersed audience across multiple countries and functions.
    • Equipped them with a robust communications, engagement and change enablement plan which included a change readiness toolbox and specific engagement forums. 
    • Provided them with the news first and opportunities to shape CTR messaging.
  • Developed 7 highly targeted personas for the key roles affected to help people understand what EU Clinical Trials Regulation meant for them. Each had their own self-service communications and training plan using cohesive, visually appealing materials. 
  • Created a refreshed and resonant narrative which vividly illustrated the benefits of the new way of working versus the old. Delivered through targeted collateral including a key message framework and stakeholder engagement presentation.
  • Captivated stakeholders with a compelling and engaging visual identity, utilising fun, colourful and memorable visuals based on a classic television programme that stuck with audiences juggling competing priorities and messaging.
  • Created a one-stop-shop gSite to serve as a communication tool which promoted the CTR story, celebrated progress, entertained and offered guidance and access to CTR learning whilst establishing a CTR community.
The Differences We Made

The Differences We Made

“It has been an absolute pleasure and joy working with (Afiniti on CTR). The quality of all the deliverables produced are clear for all to see…beyond the ‘outputs’. I was impressed and appreciative of how quickly and easily (Afiniti) began driving the change efforts forward in an impactful way.”

– CTR Lead
  • Through Afiniti coaching and support, the Core Connectors led engagement activities (including briefings, updates, learning materials and information sessions) with their own functions by speaking from a place of knowledge and experience. 
  • Executed a regular cadence of communications including:
    • A monthly informative Network Nuggets newsletter – sent to 425 people.
    • Educational and interactive “Smart-Sessions” to update impacted employees throughout – attended by an average of 400 people.
  • Provided comprehensive support at all stages via:
    • 2 rounds of impact assessments for nearly 20 roles in approximately 30 countries in 16 functions.
    • 75 sustainable learning resources, tailored to the 7 key personas.
    • 1:1 support sessions with change champions network to ensure they had what they needed to drive adoption.
  • More than 44,000 people have visited the EU Clinical Trials Regulation gSite since April 2022 and the page has been accessed over 52,000 times.
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