What Drives Quality? – Part I

Quality should be the bedrock

It should be the characteristic that runs through a company from top to bottom, like lettering through a stick of seaside rock.

It should be the governing principle that defines the way a business delivers services to its customers.

Everyone knows this.

Quality should be the bedrock

So why is it so difficult for companies to deliver a top quality product or service on a consistent basis?

General Principles

When you’re considering the principles that drive quality, it’s useful first to think in general terms. So you should:

  • establish clear standards that everyone understands
  • find the right people with the right mindset – and qualifications – to implement those standards
  • be vigilant to ensure those standards are adhered to
  • lead your team in avoiding ‘quality fatigue’
  • re-connect with core quality values periodically to make sure there’s been no drift

The commitment to delivering quality must be broad and deep, it must involve both your people and your processes and be the key motivator for everyone in the company

– from those who look after the big picture to those who pore over the individual data points that make the business tick.

Let’s look at how we might apply these general principles to the biostatistics and programming aspects of the pharmaceutical business.

The Keys to Quality

Quality needs to be quantifiable so that you can assess whether you’re meeting your own benchmarks, but it can mean different things to different people. In a pharmaceutical trial for example, the various stakeholders are likely to have contrasting views as to where the emphasis should lie, depending on whether they’re the CRO, the client or the auditor.

From the CRO point of view, quality means having the processes and the people in place that allow the organisation to get the results right, first time, every time; that’s the foundation upon which everything else depends.

The client on the other hand, demands all that plus first class communications, transparency (particularly in terms of planning and risk management) and reassurance in the form of regular meetings or updates.

Then there’s a third, competing demand because if the auditor comes calling then detailed documentation needs to be in place to satisfy a rigorous examination and to demonstrate proper process and adherence to Good Clinical Practice (GCP).

Quality In-House

Building a team that can deliver consistently high quality results is a bit like putting together a complex jigsaw puzzle, because the people involved must have the right combination of skills, qualifications and experience.

At the same time, the team must understand exactly what’s expected in terms of quality and having established the ground rules, management needs to re-visit this periodically.

Forensic attention to detail of all available documentation such as the study protocol, the Statistical Analysis Plan and the dataset specification – even to the Table Shells themselves – is vital to ensure consistently high standards are maintained.

When you’re able to work at that level of detail, everyone in the team understands exactly what’s required – right down to the necessary number of decimal places in a specific statistic.

Quality In Relationships

Although it may seem counter-intuitive, it’s possible to produce perfect deliverables, on time, and still end up with a client that isn’t happy.

That’s because it’s the quality of the relationship that keeps clients happy and drives repeat business.

If a client has doubts or feels uncertain that their CRO of choice will be able to deliver a project on time or to the required standard, they’re going to lose trust even if you hit every milestone with quality results.

This is where transparency comes in. Working together in a collaborative manner promotes respect within the client relationship along with an important sense of shared responsibility.

Quality For Auditing

“If something isn’t documented, it didn’t happen.”

If your processes are in place, your staff have the right skills matrix and your governance is strong, then an audit will merely confirm that your study conduct, performance, monitoring, analysis and reporting meet the required international standards of GCP.

Understanding how this fusion of world class technical documentation and a good client relationship go hand in hand in driving overall quality is crucial in terms of delivering a great service to your clients, and doing it consistently, time after time.

Veramed is a CRO that provides a range of high quality biostatistics and programming services for the design, reporting and analysis of clinical trials.

Please get in touch for more information.