Quality assurance plays a huge role when it comes to conducting 100% efficient clinical trial. Ever since the Pharmaceutical, Clinical and Medical industry has started to shape and contribute to the economic growth of one country, there has been an increasing focus placed by regulators on using quality systems throughout every step of a particular research. The integration of such systems is indicated to serve a number of purposes. Above all it promises fewer inefficacy rates when it comes to pharmaceuticals as well as other medicinal products and it also reduces unplanned costs and additional time spent on already executed procedures.
Throughout different time periods the researchers have been noted to be using quality-assurance processes after the appearance of some problem or defect. This is rather ineffective and hinders the smooth development of medicinal products. On the other hand, if the quality-assurance is inserted into a working quality-management system, it will allow the assigned personnel to carry out quality-assurance activities before such issues have happened. And, of course, this will save a lot of unnecessary efforts, time and money. Presently, the systematic methods used to ensure better quality are more or less outdated. Following predefined steps, practitioners produce specific products, find the ineffective ones among them and, then, throw them out. Still, this type of removing of clinical trial data after an already presented defect is, to a great extent, wasteful.
In order to avoid such crisis, it has been suggested that the use of risk-based quality assurance is more efficient than the methods used now. But how does risk-based quality assurance work? The risks are evaluated and predicted by the regulator who considers their likelihood of occurrence and the potential effects on the overall clinical trial. Moreover, this sort of assurance is able to enhance the nature of work when performing a study in a number of ways. In addition to this, it can also improve the whole study by simply initiating better communication, bigger exchange of information between parties and strengthened clinical trials transparency.
In summary, risk-based quality assurance represents a systematic process. It is used by regulators to identify, evaluate, control and review the risks related to a clinical study’s lifecycle. Adapting such type of quality assurance supports the principles and stipulations of Good Clinical Practice (GCP). Lastly, just as any other procedure, the implemented risk-based quality assurance should be properly documented and incorporated into existing quality systems.
