The global COVID-19 pandemic has become a catalyst for the pharma industry and the US Food and Drug Administration (FDA) to implement long-awaited innovations. The urgent manufacturing needs caused by the pandemic and the requirement for social distancing are driving pharma companies and regulators to finally deploy advanced technologies that have been suggested for years but never embraced, says GlobalData, a leading data and analytics company.

Peter Shapiro, PhD, Editor-in-Chief at PharmSource and Senior Director of Drugs and Business Fundamentals Databases at GlobalData, comments: “The demands of the current COVID-19 pandemic mean that the promise of disruptive technologies such as real-time digital quality management, advanced logistics due to serialization, and virtual reality inspections no longer seem so unrealistic.”

“The use of quality oversight by real-time monitoring of quality could be a future evolution of drug manufacturing as a result of this pandemic to continue quality and reliability of the drug supply. This is especially true if the FDA’s changing attitude to clinical trial requirements is considered to be an indicator of its plans for manufacturing.”

GlobalData expects that some changes to the FDAs regulation of clinical trials will continue moving forward past this pandemic.  The FDA may find that decentralized trials, the use of real-world evidence, and master protocols will be beneficial to running clinical trials in general.  Clinical trials have adapted in the face of changing technological requirements.