The COVID-19 virus diffusion is, nowadays, global and any clinical trial is potentially affected by the direct and indirect consequences of the COVID-19 during the pandemic. Any step, from protocol design to result’s disclosure, needs to be revised to assess the impact of the COVID-19 on the study, evaluate the potential risks, and establish a mitigation plan. We have developed a series of recommendations, belonging to our experience in any aspect of clinical trials.
We hope that the Risk and Mitigation actions for clinical trials during COVID-19 Pandemic (RiMiCOPa) will help all clinical trial professionals, patients, auditors, and assessors to ensure effective data management, statistics, and medical writing standards while conducting clinical trials in the pandemic.
We are thrilled to announce that the National Center for Biotechnology Information published a new scienfitic article titled “Risk and mitigation actions for clinical trials during COVID-19 pandemic (RiMiCOPa)” written by Antonella Bacchieri, Senior Consultant Statistician of CROS NT, and Paolo Morelli, CROS NT CEO, in collaboration with Andrea Rossi, Consultant in Medical Writing, Communications and Scientific Affairs.
The RiMiCOPa document, based on EMA and FDA guidelines, provides advice to evaluate how the different aspects of clinical trials should be handled to mitigate the impact of pandemic on data management, statistics, and medical writing activities, maintaining the required quality standards.
Would you like to understand how to navigate a business in times of COVID-19? Read the interview with our CEO Paolo Morelli “Navigating Business in Times of COVID-19”.