What Drives Quality? – Part III

How enduring partnerships grow from good governance

We’ve argued elsewhere that delivering excellence relies on striking a balance between the ‘three pillars of quality‘ – your people, your processes and the way you support both with technology.

This is a difficult enough balance to strike when you’re talking about one or two teams delivering one or two projects for one or two stakeholders, but what happens when you upscale?

How can a CRO continue to deliver quality as the business grows and they take on more clients and projects?

How enduring partnerships grow from good governance

In order to deliver quality at this larger organisational level, we believe there are several elements that need to be put in place, specifically:

  • switching from tactical activity to strategic planning
  • moving from transactional arrangements towards a true partnership
  • demonstrating the ability to leverage information to maintain quality during periods of growth

The key to implementing these elements successfully is what’s known in legal circles as a ‘mastery of the brief’ – or in our case, a forensic understanding of the systems and principles required to oversee multiple clinical trials (sometimes with different clients) through to their successful conclusion.

We call it ‘good governance’ and we believe it’s central to preserving the integrity of the three pillars of quality

Good governance isn’t just about controlling budgets, metrics and other Key Performance Indicators (KPIs) – though these are important.

It’s also about being able to work successfully with key decision makers and influencers across teams, departments and entire organisations to build trust, and to create living, breathing partnerships that run far deeper than the traditional, often transient, business relationship.

It requires that the CRO has a granular understanding of the staffing and resourcing required to complete multiple concurrent studies, as well as the ability – and the willingness – to share those insights with clients openly and with complete honesty. This depth of collaboration furnishes the CRO and the client with the capacity required to plan for unknowns, and ensures the partnership has the necessary organisational agility to switch focus when required, to move resources in order to relieve unforeseen pinch points – even to reconfigure entire teams in order to meet the challenge of new priorities. Working this closely together allows you to manoeuvre more effectively should workloads increase unexpectedly – and to cope with the resulting rise in ‘temperature’.

Although we’ve touched on this before it’s also important to understand that good governance is about much more than following standard operating procedures (SOPs). These need to be understood and applied of course, but they must also be subject to continuing critical review so that they don’t take over and turn the process into an exercise in ticking boxes. That’s why the central plank of good governance is the ability to exercise control over projects, resources and quality across the whole range of clinical studies, whether these are current, planned or scheduled for sometime in the future.

Good governance can be the platform that gives the modern CRO the confidence to say ‘no’ from time to time – passing up on a project if the right resources are not available to deliver a quality product (rather than yielding to the persuasions of the sales team). Too few people chasing too many deliverables will create the perpetual crisis cycle; and while there’s nothing wrong with small doses of timely pressure, constant stress will inevitably result in a loss of quality.

Good governance – encompassing oversight, escalation paths, monitored feedback and effective risk management – applied across the project and client portfolios and at every level allows today’s CROs to embrace new and expanding collaborations with confidence. That’s because deep partnerships of the kind we’ve been describing – courtesy of good governance – enable CROs to understand what drives their clients, helps them to work in a transparent fashion that promotes trust and leads to the ultimate goal – shared values. Achieve that and the quality of your work will be exceptional, no matter how big your client base becomes.