As a small CRO, one of the key challenges to staying valuable is flexibility.  At DZS, we are constantly looking for ways to improve our Data Management service.  We know the CDM team can make your clinical trial process more efficient and encourage a habit of continuous improvement.  Conversely, the CDM function can limit speed and reduce overall efficiency.  Flexibility is critical to improving, yet Data Management teams often avoid change in favor of consistency.  But, being consistently inefficient is not a long-term solution.

We have identified three ways a Data Management organization (internal or external) can be flexible and improve consistently without being disruptive in a negative way.

1.      Have a highly-collaborative working relationship with process improvement as a continuous agenda item.  Not just with the Sponsor but with other functions.  Some of the best improvement suggestions have come from IT and our Clinical Monitors.  In working with a large Pharma company, we solicited input from every function to develop a highly efficient 4-part CRF for their paper studies (yes, they still exist).  Each function contributed and each needed to compromise. The process worked, not only because it was more efficient, but also because each function contributed and had a “stake” in the process.

 2.      Identify and prioritize.  We often dismiss suggestions immediately because we perceive them as too much work, or not worth the effort….and sometimes they are.  But that’s not the point.  If you want to develop a culture of improvement, develop a way to identify and evaluate suggestions over time.  The proverbial (mental) suggestion box – any type of actual box will likely bring scorn and comparisons to Michael Scott.  By identifying suggestions over time, you create a predictable way to evaluate various approaches and at the same time, allow your employees an opportunity to provide input without having to give an immediate thumb up / thumb down response.

 3.      Build processes with the understanding that they will be evaluated.  Unless there is a reason for absolute rigidity in process – and sometimes there is – build in room for evaluation.  In fact, it’s a good idea to pre-plan it.  We often develop processes for our Sponsors without complete information.  It just happens.  So plan for the unknown.  We often conclude a decision with the statement, “…and we’ll look at it in 3 months to see if we need to change anything.”  This allows us, and our Sponsors, to move forward confidently knowing that we may need to adjust along the way.

We continue to find ways to enhance our service and building in flexibility along with a continuous improvement approach allows us to do that.  What ways have you seen CDM groups become responsive to process changes?