Business Change Case Studies
Case Study

Enabling Teams to Focus on What Matters; Study Risk, Data Integrity & Patient Safety

Project Overview

Central Monitoring is the next phase of maturity in our client’s holistic clinical study risk management strategy; reinforcing cross-functional monitoring, data surveillance and the use of analytics to help study teams to focus on the right work at the right time. Our client’s goal is to drive smarter trial execution, increase study data quality, improve patient safety and get medicines to patients faster.

Central Monitoring builds on foundations laid by Risk Based Monitoring (RBM), which commenced in 2015. RBM made great progress in embedding enhanced risk monitoring principles but our client continues to experience challenge managing site and study risk in a joined-up way, and in the cohesive end-to-end monitoring of data across our functions and based on real-time data review.

The real challenge was how to get the attention of key stakeholders with so many other initiatives – at the transformational, organisational and functional levels – to engage, achieve commitment and adoption, of Central Monitoring.

Rather than have study teams view Central Monitoring as ‘an additional task’ in an already time poor environment; we needed to change the conversation, emphasising the use of data to gain insights to mitigate and manage operational risks; which was already being done. Central Monitoring does it smarter, enabling study teams to focus on what matters most; study risk, data integrity and patient safety. Central Monitoring is about managing risks centrally – more holistically, efficiently and collaboratively.

We partnered with our client to manage change, communications and learning, to drive adoption and embed new ways of thinking and working for the impacted roles and their communities.

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Our Solution

We were tasked with acting as a programme management, change and communications partner Programme Manager and Change partner to augment the internal programme team and further to add value through business change capability. The programme was initially structured in two phases; the first in 2019 preparing for delivery of new people, process and minimum viable product system to early adopter monitoring study.  This evolved into an Agile at scale (Nexus) delivery approach in 2020, building on learnings from early adopter deployment to refine and develop Central Monitoring capabilities for a broader, cross functional deployment in 2020.

Afiniti provided change management leadership across the programme; accountable for the leadership, coordination and delivery of the change scrum (a cross functional and collaborative team including change, comms, learning & support network resources). The change scrum focussed on providing clarity, guidance, learning resources and support to build user readiness for deployment of incremental products released through project sprints. In parallel, the approach to building awareness, understanding and buy in to the benefits of Central Monitoring in the wider business was based on real user stories. The experience, insights and feedback from early adopter studies helped us build those stories and provide an engaging, honest narrative around the changes.

The Differences We Made

We were able to mobilise quickly to understand the current state and produce a change management plan to demonstrate the path forward.

With agile execution at our core, we were able to understand, interpret and adapt to the changing business priorities within the client environment without any change to business timelines.

Knowledge. We were able to draw on our industry experience to tailor our solution to the client’s needs.

The sought benefits of Centralised Monitoring for our client were threefold – more than just monitoring differently:

  1. Driving smarter trial execution, increasing patient safety and data quality
  2. Driving efficiency and cross functional data review
  3. Proactively identifying and managing impactful study risks.
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