Apr07

Climbing the Quality Ladder in Clinical Research

In clinical research, quality is particularly essential. Without it, your organization risks having garbage data, as well as the potential of future business with your research partners. As you grow, evolve and adapt to the changing world of research, you and your team need to ensure quality is being taken seriously and best practices are being implemented at all times. A recent webinar with Lorraine Ellis of Research Dynamics, LLC discussed research quality in depth. That webinar can be seen here, but here are a few bits we found particularly helpful:

Key Points of Clinical Trial Quality

There are lots of reasons to implement quality initiatives at any organization. In research, however, there are a lot of stakeholders who could see harm as the result of poor quality – from sponsors down to patients – so it’s always important to be well aware of why research quality should be taken seriously. A few points:

  • Subjects’ welfare and rights are protected
  • Consistent protocol implementation and protocol compliance
  • Accurate, consistent, and complete data
  • Complete product accountability
  • GCP compliance

Establish a System of Quality

To keep this initiative fresh in the minds of everyone at your organization, set up a clinical trial quality system. At a high level, these are the four key steps:

  1. Set up systems and processes for Quality
  2. Design policies, processes, and procedures for project execution to deliver a consistent outcome that meets quality requirements
  3. Design and maintain systems that measure process execution and outcome
  4. Create a culture of compliance and accountability

Understand the Quality Process

Quality isn’t just an initiative to roll out over a quarter or two, it’s a never-ending process that gets built into every study and every project at your organization. Key steps to this process:

  • Standardize
  • Train
  • Measure
  • Resolve

It is important your team takes these steps to make sure your organization is operating at maximum quality. As you measure, make sure to look for consistency. Once your processes are set up correctly, you will notice consistency. This is a sign of growth and increasing quality!

To learn more about clinical research quality, check out the webinar that inspired this article!