The ICH-E14 guidance does indeed call for an “adequate representation” of female subjects in clinical trials, although not specifically for the Thorough QT (TQT) study. However, most TQT studies follow this recommendation and enroll sufficient numbers of female subjects. Interestingly, the issue of enrolling subjects with higher sensitivity to drug-induced QT prolongation and arrhythmia in TQT studies has been widely debated. Some also suggested that TQT studies with male-only subjects would reduce the well-known physiological variability in the QT interval and would therefore make these studies more efficient, requiring less subjects to meet the primary endpoint with sufficient statistical power. Nevertheless, the practice of “male-only” TQT studies has not been taken up and most TQT studies aim at enrolling equal proportion of male and female subjects.

Visualization technology supports the saying that “pictures are worth a thousand words.” In today’s environment where clinical trials are becoming increasing complex and increasingly multinational, visualization can be a tool to more effectively convey what should be done or what the final product should look like.

Additionally, the assembly process itself can sometimes be better depicted using visual tools than words. Historically, one-dimensional pictures, diagrams, and graphics have commonly been used to help in this area, but today visualization software is now available to take this to the next level. With pictures, the final package must be “mocked up” to show final specifications. In the case of visualization, it can be created ahead of the operation without the use of actual components. The visualization software can also provide multi-angle views of the product allowing for greater precision.

These software programs are also CAD based, or in other words, all dimensions are exact not just a simple rendering that may not show exact measures.

One of the first misunderstandings to correct is that there is a single solution for any supply chain that involves distribution services to more than one local region and/or any type of sensitive product. A better approach is to break down the supply chain to various components involving understanding the lanes of transports, the underlying weather, local, regulatory challenges, and to build a strategy that leverages a risk management approach. The investment that you make in upfront planning will pay huge dividends in the enhanced predictability that a solution-based strategy offers.

Efficiency will result from the predictability so that the time clinical development, clinical supply, and investigative site staff spend is invested in proper setup rather than reactive and focused on remediation.