February 26, 2019 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Jeffrey Smith, VP and Chief Operating Officer of MOORE Clinical Research, Inc.

Jeff, what do you think it's about time we do?

Norm, glad you asked. I think it’s about time sites get serious about quality management systems.

Why now?

In the past, study sponsors looked for sites that could enroll patients. If you could enroll patients, they would work with you on the rest. They didn’t focus that much on quality, for one reason, because they didn’t have the systems to track it. Now, they do have those systems. Leading sites have evolved so that they can deliver both patients and quality. Sites that want to survive, much less grow, have to keep up.

What, exactly, is a quality management system?

A quality management system (QMS) gives a site the infrastructure to deliver consistent, high-quality performance that meets internal, customer and regulatory requirements. A QMS has five components: (a) a system for hiring, onboarding and motivating employees; (b) standard operating policies and procedures (SOPs); (c) a training program so employees know how to follow the SOPs; (d) a quality control program to ensure the SOPs are followed; and (e) metrics to measure performance and drive improvement.

That sounds like a lot. Given that so many sites are going out of business, how can sites afford to invest in a QMS?

Norm, that’s the wrong question. The right question is how can a site afford not to invest in a QMS? In addition to the changing customer expectations I mentioned before, it was proven decades ago that quality pays for itself. If you don’t have time to do things right the first time, how are you going to find the time to do them wrong and then do them again right? If you don’t have a QMS, how are you even going to know what you are doing wrong and where to focus on improvement? More and more study sponsors want evidence, in advance, that a site will do quality work, and a QMS gives you that evidence.

It still seems like a big lift for a small site.

Absolutely, and it’s an even a bigger lift for a big site. That’s why each site should eat the elephant — or elephant fruit, if you prefer — one bite at time. Start small and then build a QMS from there that best suits the needs your site. Don’t be surprised if it takes a year or more to develop a mature QMS.

So it's like growing a tree, right?

Yes, and you know the two best times to plant a tree? Twenty years ago, and today.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.