Taking EU Clinical Trials Regulation Into The Future
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.
- 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
- 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.