Supporting an international oncology company to enhance their global quality approach

A multinational oncology company wanted to improve its approach to Good Clinical Practice (GCP) quality across its Global Clinical Operations (GCO). They needed to do this to support their ambitious global R&D pipeline expansion plans outside of their primary market, which would require a stronger approach to quality in order to compete and satisfy customers in new markets. 

The organisation had three requirements:   

• Shift mindsets within GCO from a reactive, tactical approach, to a proactive quality culture where quality is embedded in day-to-day activities 
• Design a Global GCP Quality framework that effectively connected strategy, governance, roles, processes, and systems 
• Define clear roles and responsibilities across regions to enable stronger collaboration across GCO  

Baringa’s leading expertise in R&D transformation 

We were selected as the delivery partner because of our deep expertise in advising global pharmaceutical companies on R&D quality across the pharma value chain. We brought proven experience in designing governance models that support compliance, quality and inspection readiness.  

This project also built on our previous work with the client to design an initial GCP quality strategy and inspection readiness approach. 

Central to our approach for this engagement was our proprietary Quality Systems maturity model, which helps pharma companies evolve from reactive inspection engagement, through to an enterprise-wide focus on quality, and ultimately to making quality a competitive advantage.   

Our work with the client focused on the first step in the maturity model: developing an approach where functional quality policies and processes are embedded across markets. 

Our ‘people-led’ approach was important as the GCP Quality Framework needed to be supported within the GCO teams, so the practical benefits of a single, well-defined approach to quality could be realised. 

Alongside this work, we were also delivering an R&D process simplification programme, learning & development (L&D) initiatives and a change management approach within GCO, allowing us to take a joined-up approach to R&D transformation with the overall intent of increasing quality maturity across the organisation.  

Consistent quality approach embedded in the organisation 

Over the course of three months, we led the delivery of the GCP Quality Framework. We supported the client to define a vision for the quality framework, in order to set expectations across the organisation about the value the framework would bring. We facilitated global workshops to co-create the framework content. 

We also shaped a quality dashboard for the client, to showcase how they could use live reporting to ensure real time monitoring of compliance, quality, and inspection readiness against defined metrics. 

We used our tried and tested R&D change management approach to drive adoption of the framework. This involved working side by side with teams across markets to communicate how it should be used, and developing training modules to upskill teams across the organisation. 

The resulting framework now serves as a governing document for future quality policies and processes. The framework provides a single, enterprise-wide reference point for GCP quality guidance, which can be evolved over time to support a consistent approach to R&D quality across the business.