Advancing EU Clinical Trials Regulation Implementation Through Organizational Excellence
Project Overview
The European Medicines Agency’s (EMA)EU Clinical Trials Regulation (CTR) became operational across the EU/EEA on January 31st, 2022, designed to modernize application and approval workflows. Organizations failing to achieve CTR compliance face substantial financial and operational penalties, making adherence essential for any enterprise conducting clinical research within the EU/EEA region. Beyond regulatory compliance, proper implementation ensures enhanced patient protection and research integrity.
In early 2022, a multinational pharmaceutical and diagnostics corporation partnered with Afiniti to strengthen their organizational transformation capabilities around CTR implementation and establish change preparedness across their workforce engaged in EU/EEA clinical research activities. With an objective to enable 4,000 affected team members to master new technologies, refine operational processes, and adopt fresh mindsets required by these updated regulatory standards, Afiniti crafted a comprehensive change and engagement framework designed to help teams grasp and implement new operational methodologies.
Our Strategic Approach
- Established a dynamic network of 17 change advocates (“CTR Core Connectors”) positioned to engage a geographically distributed workforce spanning multiple territories and business functions.
- Provided them with an integrated communications, engagement and transformation enablement framework featuring a change readiness resource library and dedicated engagement platforms.
- Ensured they received information first and had input opportunities to influence CTR messaging development.
- Built 7 precision-targeted role profiles for the primary positions impacted to help individuals understand how EU Clinical Trials Regulation affected their specific responsibilities. Each profile featured customized self-directed communications and training programs utilizing cohesive, visually compelling materials.
- Established a renewed and compelling organizational story that clearly demonstrated the advantages of new operational methods compared to legacy approaches. Implemented through focused materials including a core messaging blueprint and stakeholder engagement deck.
- Engaged stakeholders through an innovative and captivating visual brand identity, incorporating vibrant, colorful and distinctive imagery inspired by a popular television series that resonated with audiences managing multiple priorities and competing messages.
- Built a centralized digital hub (gSite) functioning as a communication platform that promoted the CTR transformation story, recognized achievements, provided entertainment value, and offered guidance plus access to CTR education while fostering a CTR professional community.
The Impact We Delivered
“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 facilitated engagement initiatives (including briefings, progress updates, educational materials and information sessions) within their respective functions by communicating with authentic knowledge and practical experience.
- Implemented a consistent communication rhythm featuring:
- A monthly informational Network Nuggets publication – distributed to 425 recipients.
- Educational and interactive “Smart-Sessions” to keep impacted employees informed throughout the process – averaging 400 participants.
- Delivered end-to-end support across all implementation phases through:
- 2 comprehensive impact evaluations covering nearly 20 roles across approximately 30 countries within 16 business functions.
- 75 enduring educational resources, customized for the 7 primary role profiles.
- Individual consultation sessions with change advocate network to ensure they possessed necessary resources to drive adoption.
- Over 44,000 professionals have accessed the EU Clinical Trials Regulation gSite since April 2022, with the platform receiving more than 52,000 total visits.
To get the latest change tips, advice and guidance directly to your inbox, sign up to our monthly Business Change Digest.
