Compliance, Clinical Operations, or Quality: What Team Do You Play For?

July 3, 2019 Arti Bajpai

Remember the movie Miracle? It tells the inspirational story of the 1980 U.S. Olympic Hockey team – a mashup of college players who delivered a surprise upset against the pros representing the U.S.S.R.

Early on, Coach Herb Brooks notices how much individual players were identifying with their college teams, and how old rivalries were affecting their collaboration on the ice. In a pivotal scene, he makes the players skate sprints until one comes up with the correct answer to this question: What team do you play for? Until that point, they would have answered “University of Minnesota” or “Boston University.” The right answer, of course, was “The United States of America.”

In leading and consulting on quality in pharma companies of all sizes, I’ve observed a similar phenomenon: teams still thinking and working in Quality, Compliance, and Clinical Operations silos. Each group of professionals is highly knowledgeable and committed to their roles and responsibilities. Yet sometimes that commitment can prove counterproductive to optimizing the cost, speed and quality of trials. Too often, there’s a heavy focus on cost and speed, with quality and compliance treated as afterthoughts at best or “necessary evils” at worst. I see it happening when…

  • Teams aren’t looking at the bigger picture or working together to proactively establish a common approach for sharing data and metrics – which is key to applying learnings from one study to the next.
  • An organization has not established a process for knowledge management or organizational learning.  
  • Everyone stays too siloed to join forces on identifying – and tackling – process improvement opportunities and establishing continuous improvement through a formal quality model.

In short, sometimes pharma professionals need a gentle reminder that they are, in fact, on the same team – driving toward the same goals. And when everyone builds processes to support quality and compliance, the cost of trials will go down while the speed will accelerate.

As I explain in my new YourEncore white paper, Quality Management Systems: A Business Imperative, quality is no longer solely about completing checkbox audits, meeting compliance requirements, and correcting problems after the fact. Quality is now recognized as a critical strategic enabler – one that can play a vital role in how your organization identifies, manages, and mitigates risks, optimizes processes, reduces costs, and, ultimately, achieves better business results.

The paper also explains the Quality Continuum Model, which provides a flexible framework that can work for companies of all sizes and structures. It offers three core elements that span all study phases – Quality Planning, Quality Management, and Quality Improvement – and are intended to support a cycle of continuous improvement. But the model only works when every “player on the ice” is part of a collaborative team focused on shared goals, not organizational silos. It’s an approach that paid off for that 1980 team – and I’m confident it will help your organization win, too.

Ready to learn more about the Quality Management System and how to bring it to life? Check out the new white paper. If you’d like to connect directly, drop me a line at COE@yourencore.com.


 

About the Author: 

Arti Bajpai

Managing Expert, YourEncore Quality Center of Excellence

 

Arti Bajpai is a visionary Quality and Compliance expert driving continuous process improvements. She consistently works to gain trust, achieve results and build efficiencies. 

As a seasoned expert in Compliance and Quality, Arti’s experience provides the foundation from which she leads innovative change and establishes proactive compliance and quality management within organizations.

Arti is the former Senior Director of R&D Compliance and Process at Shire, and is now a Managing Expert in YourEncore’s Quality Center of Excellence, helping clients manage, strategize and innovate their Quality processes.


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