Business Change Case Studies
Case Study

Achieving a Positive Mindset Shift Across a Complex Global Audience to Drive Clinical Trial Excellence

Project Overview

A leading global Pharmaceutical company needed Afiniti’s help with a ten year challenge regarding clinical trial documentation…

Clinical trial documenting processes are not only recognised as highly important, but also subject to industry regulatory compliance expectations. Yet four change programmes spanning ten years had failed to achieve the desired change in behaviour. A deeper mindset change was required. We had to influence a different way of thinking about the Trial Master File (TMF) through positive reinforcement, in order to be successful in changing how people interacted with the TMF and ultimately accelerate development timelines to deliver for patients.

Afiniti partnered with our client to implement a fun, positive patient driven with engaging content to drive new TMF Healthy Habits, new TMF ways of working and a new TMF culture. Campaign messaging encouraged TMF users to spend regular amounts of time keeping their TMF healthy and in shape, with a serious undertone: We owe it to our Patients.

The 12 month campaign had to overcome unforeseen technical challenges, organisational restructures, substantial historical change fatigue and a completely virtual working environment without the traditional forms of office and face to face communication.

Get in touch!
If you wish to learn more about what we do, give us a call on 0845 608 0104 or email
Alternatively, keep up to date with the latest from Afiniti by connecting with us:
Our Solution
  • Launching a new visual identity promoting Healthy TMF Habits and WoW with a Take 5 theme –  encouraging TMF users to maintain personal responsibility for spending regular amounts of time keeping their TMF healthy and in shape.
  • Leveraging powers of influence in sequence, in order to reach TMF Users as one joined up organisation – each phase aligning influential groups to the same Take 5 for TMF vision through generating their awareness, desire, knowledge, ability and reinforcement (ADKAR) in their ongoing Take 5 Team role.
  • Finding humour, interactivity and fun within a traditionally ‘grey’ area with the creation of a charismatic, TMF character champion ‘Trainer Monsieur FileFit’
  • Evidencing and promoting senior leadership advocacy and support with video testimonials & cascade activities
  • Evidencing study team and colleague video endorsement – how they reward themselves for maintaining healthy TMF habits
  • Producing resistance toolkit, communication toolkits to equip, empower and enable key roles leading change
  • Creating a rich content library – Gsite, news articles, newsletters, thank you cards, merchandising ideas, FAQs, animations, videos
  • Taking a ‘think, feel, do’ approach to achieving change
  • Positivity was key, no stick was needed
  • Creating a new TMF culture and social expectation surrounding compliance amongst peers
  • Designing a month long virtual global competition, connecting TMF users with engaging, fun learning content to increase their TMF knowledge, accountability, and understanding of why our TMF matters
The Differences We Made
  • We evidenced a positive shift in mindsets and behaviours
  • People understood the importance of this work far more
  • They were clearer on how to find support if needed
  • They demonstrated a change in attitude, and habitual change in behaviour
  • The campaign secured the visible endorsement of the organization’s global clinical compliance and global clinical practice committees
  • Colleagues evidenced a 30% increase in their improvement of their knowledge of how TMF connects with the patient
  • Colleagues evidenced a 30% increase in their knowledge comfort levels in TMF knowledge
  • Created a rich library of training content and fun learning materials to share and be part of ongoing positive reinforcement
Related Case Studies
Making Change Meaningful – Increasing the Efficiency of Clinical Trials
Delivering a targeted campaign to a disengaged audience within clinical trials.
Partners in Communication
Helping a communications team bring its channels to life and increase employee engagement for a diverse audience.
A Paradigm Shift for Clinical Trials – Risk Based Monitoring
Creating and delivering an engaging Learning and Communications strategy to establish global adoption of Risk Based Monitoring.