There is a lot more riding on the success of an imaging trial today than ever before. The world economy, mergers and acquisitions, the state of sponsors’ pipelines and changes in the regulatory environment, have created the most demanding market for clinical trials ever. One of the results of this evolution is the increased focus sponsors put on the finest detail of each project, and on the most esoteric budgetary line item.
As imaging trial sponsors have turned a bright light on their suppliers to illuminate the nitty-gritty details of trial operations, the suppliers have found it necessary to focus on their core competencies and “specialize.” Because of this focus, the competition for imaging trials has greatly increased, and newcomers’ ability to carve out a niche and excel within it, has been a successful strategy for many. Existing technologies have been used by these suppliers to contribute to their core mission, and bolster their ability to execute. Everything else is noise.
For specialized functional suppliers, a focus on quality and risk management can dramatically improve performance. The best place to find these improvement opportunities is within their core functions (i.e., data analysis), not outside their core competencies. The former adds value, while the latter adds noise. As an example, imagine that engineers at a car manufacturer decided that they would start making their own stereo receivers, rather than using the best available sound systems on the market. Their rationale might be that as long as their sound system fulfills the basic requirement of producing sound, they will be good enough to “check the box.”
“Think of all the revenue we could keep for ourselves!” Couldn’t the money spent on this sub-assembly have been better put to use in a better transmission, a lower emission engine, or a smoother riding suspension? Or perhaps, procuring the stereo could have resulted in a higher quality sound system at a lower cost for their customer.
Every detail, resource and function required to manage an imaging clinical trial is vital to the success of the program. Attempts to focus beyond the limits of a provider’s core competency is a distraction which either dilutes a core lab’s attention, or worse, introduces noise into an already complex process.