Dawn Niccum at inSeption Group published a piece about gap analysis in the clinical trial space; if you are interested in the entire piece you can read the PDF here. The main focus of the article is the significance of the gap analysis regarding a life science organization’s quality management system (QMS).
Among the most prominent shortcomings of the QMS, Niccum points out, is inadequate risk management. If a company is not properly documenting their risk-based approach, the exercise can fail. Document management can also become a prominent concern…a company may not be using a validated system to store documentation, or a system that doesn’t provide user-friendly access to controlled documents. Another potential issue with QMS can be vendor management problems, such as insufficient oversight.
Gap analysis, Niccum suggests, is best performed during the initial entry into a clinic, rather than a later phase of development. It is much easier to make changes, adjust personnel behaviors, and alter procedures earlier in development, ultimately resulting in lower costs and less administrative headaches. As Niccum states, “one cannot retroactively build quality into a process that already has been implemented.”
That said, gap analyses can still provide a true benefit later in the development process, especially if that portion of the process can be up to four or five years. Even late in the development, it can benefit a company to be able to show that it is improving its processes.
One important part of gap analysis, Niccum shares, is the importance of collaboration. An effective gap analysis includes conversations with key personnel, and viewing outputs from standards operating processes. It’s critical to assist a consultant’s understanding of a client’s own awareness of its processes. A gap analysis can then produce a “report card” with areas for improvement.
In summary, while a biopharma might have confidence and faith in its personnel and partners, it’s vital to trust but verify, and ensure that those procedures are being followed. With an effective gap analysis, a biopharma has an insurance policy that they can share with sponsors to build confidence. The end goal, Niccum writes, is “helping a client to a point where they no longer feel they need additional guidance or assistance.”