Turning Q&C into a competitive advantage
To succeed in this industry, you have to achieve the highest possible quality of research and development.
Yet, a surprising number of R&D professionals don’t believe their organisations have an embedded Quality Culture.
In a recent Kinapse survey of Quality and Compliance leaders, only 37% said their functions were perceived as valued business partners. The majority (63%) believed they were seen as a ‘necessary overhead’ or a ‘non-strategic service function’.
Quality and Compliance functions can be more than just valued business partners – they can be a competitive advantage. But, they have to work as part of a wider Quality Culture to be effective.
In this short position paper we will:
- Define the term Quality Culture
- Explore quality as a source of competitive advantage
- Outline how pharma organisations can move towards a Quality Culture.
1. What is a Quality Culture?
We define Quality Culture as an environment where quality enables good R&D, where:
- Management of quality is seen as an integral part of achieving organisational and individual objectives, not a separate exercise.
- Quality is built into processes, not bolted on at the end.
- Quality and the business work as partners.
- Senior leaders are active and consistent advocates of the right behaviours.
- Staff are empowered to take decisions.
How does the quality environment at your R&D organisation match up?
2. Can quality be a competitive advantage?
We believe that quality can significantly contribute to the success of an R&D organisation in four key areas:
Avoiding fines and litigation is often the main concern of R&D leaders considering quality and compliance. And with good reason: the price of non-compliance is on the rise, and some recent fines have reached several billion US dollars.
However, a strong Quality Culture can also reduce R&D costs. By eliminating Q&C issues in the R&D cycle, organisations can save a substantial amount of money. For example, quality issues resulted in the following costs for a recent Kinapse client:
- € 3.5m for the re-monitoring of a study.
- € 2.7 m for several audits resulting from Poor phase IV data quality.
- €50 m on the abandonment of a label change due to critical findings.
Additionally, any issues in the R&D function inevitably cause delays in getting to the market. As a result, businesses could stand to lose sales and market share.
A Quality Culture not only reduces avoidable costs, but it can actively contribute to product success. By demonstrating consistently high data quality, R&D organisations can build confidence among regulators and payers, and ultimately improve their chances of successful regulatory approval, reimbursement and market access.
Finally, a Quality Culture is essential to building trust in our industry.
Patients, healthcare professionals, payers and regulators need to have confidence that the industry is behaving ethically. Serious quality issues such as unreliable clinical data can lead to a climate of distrust and increasing regulatory intervention.
A track-record of effective Quality and Compliance control builds trust.
3. How can R&D organisations move towards a quality culture?
Quality must be a central part of the organisation’s strategy, and embedded in all parts of the operating model.
The organisation’s structure, processes, infrastructure, people and their behaviours and attitudes must all be aligned with the aim of improving quality.
A mature Quality Culture will encompass most or all of the attributes below:
Moving towards this mature state typically involves a sustained commitment from the organisation and its senior leadership. To maintain this, organisations need:
- Visible senior management buy-in.
- Acknowledgement of the need for change across the organisation.
- A quality approach that is right for your organisation, not just a “blueprint” approach.
- Effective change management and oversight.
- Tangible performance metrics to demonstrate progress.