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.
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?
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.