By Dawn Niccum, inSeption Group
Gap analysis targeting a life science organization’s quality management system (QMS) evaluates whether the organization has adequate processes, personnel, documentation, and systems in place to properly conduct its clinical trial. Its key deliverable is a “report card” — an independent analysis that can bolster the organization’s confidence in its position moving forward, as well as help to identify, prioritize, and remediate potentially problematic areas.
Gap analysis often is considered when an organization already is in a later phase of clinical development, such as Phase 3, but initial entry into the clinic is the ideal time to conduct gap analysis. The later a gap analysis takes place, the more remediation becomes necessary to address issues that have been identified. And, the farther along a product is in development, the more difficult it becomes to make changes. Not only must procedures potentially be changed, so must personnel training and day-to-day behaviors that have been ingrained.
A truly comprehensive gap analysis also loops the client into findings as the exercise is ongoing, rather than simply producing a one-off report at the end. What should the client focus on first? Which compliance issues must be solved immediately and what needs to be in place when going to market? Biopharma organizations should seek a partner agile enough to tweak the analysis based on their feedback regarding what might be helpful. A one-size-fits-all approach is ill-suited to an undertaking designed to provide client- and situation-specific guidance, particularly since the gap analysis is a start, not the end, to QMS and process optimization.