Much has been discussed and written about the potential value of metrics and how sponsors of clinical trials can use them to monitor the performance of organizations that they contract with to implement their development trials.

One such vehicle is the Metrics Champion Consortium (MCC). The mission of the MCC is to develop, through a collaborative process, performance metrics within the biotech and pharma industry with the intent to jointly encourage performance improvement, effectiveness, efficiency, and appropriate levels of controls for both sponsors and service providers including imaging core labs.

Initiatives like these should promote greater transparency between imaging labs and sponsors on what are believed to be important metrics. While most believe this is a step in the right direction, significant incremental benefits can be achieved for sponsors and imaging labs that focus on the operational improvements underlying the metrics—improvements that can accelerate the development process, allowing companies to ultimately bring new therapies to market quicker and at lower cost.

Three New Benefits for Clients

Metrics in and of themselves don't enable operational efficiencies. What can are continuous improvement initiatives applied to the underlying processes being measured. The mere existence of metrics doesn't necessarily provide any insight whatsoever as to the quality or even the existence of credible continuous improvement programs.

Unfortunately this focus on continuous improvement has not begun to happen in a meaningful way. The focus of this article is to highlight the impact effective continuous improvement programs can have on both the organizations that implement them and their clients, who in this case are the drug and device companies that sponsor clinical trials.

Driving the process

As sponsors look for new ways to accelerate their development programs, they are looking for imaging core labs that can do the following:

• Commit to and deliver upon aggressive timelines and milestones. Committing can be the easy part. According to many anecdotal stories, delivering upon these commitments can prove challenging.
• Provide more rapid and complete feedback of results to the study teams, allowing them to react much sooner.
• Reduce cost where possible without sacrificing quality or adherence to timelines.

There are multiple ways an imaging core lab can react to these ever increasing demands. The method most frequently chosen is for the service provider to develop concurrent internal processes that essentially create two classes of customers within the organization. One class that represents the most demanding projects (i.e., those requiring tighter time lines and oversight by many in the organization), and a second class of customers or projects that are worked on when there is no priority work currently requiring attention.

This methodology is sometimes referred to as the "squeaky wheel gets the grease strategy." This methodology can work as long as the quantity of special projects is kept to a minimum. It begins to fall apart as the number of priority projects grows to a point where it is hard to distinguish high priority from normal priority. Also, it is important to note that I have yet to meet a customer or study team that does not believe their project is high priority.

The alternative to this multiple priority operational philosophy is to design the organization to deliver a level of performance that routinely meets or exceeds the most demanding customer requirements on a routine basis, not just for those high-priority projects or customers but for every project and customer. This is an objective that has obvious benefits from a timeline perspective, but I would also add that it is one that can yield significant benefits in terms of efficiency and cost.

So, the far more interesting story is not one purely focused on metrics but one that highlights what is really happening within the organization putting forth the metrics to yield ongoing improvements that can make a real difference for sponsors and imaging core labs.