Today we would like to talk to you about how the processes of conducting clinical trials have changed in the face of the COVID-19 pandemic. The biggest question is about the trial monitoring process. After all, the monitor personally travels to the centers and monitors the progress of the study, and now this routine process is difficult in most cases.
For X7 Research specialists such kind of services as “remote monitoring” is nothing new. We have been conducting such “visits” for many years as part of various non-interventional studies and other surveillance programs. The company’s monitors manage to ensure proper control of the progress of the study using modern means of communication and technology.
Sergey Erokhov, Quality Assurance Manager at X7 Research, commented on the situation:
When it is not possible to perform standard face-to-face monitor visits to the research center, performing centralized monitoring of the study is of particular importance.
Centralized monitoring is a combined concept involving central review of information in patient DCFs by data management and/or medical monitors and remote monitoring by trials centers.
Central review is more often associated with the use of a combination of automatic (due to automatic scripts checking the data for logic and correct input) and manual analysis of the array of data by data management or medical monitor specialists. The peculiarity of this approach is that there is a possibility to evaluate patient data in a linear form, i.e. how it changed during the time of the subject’s participation in the study and see everything on “one screen”.
Remote monitoring captures other aspects of study control and the trial center. Here it is possible to assess the completeness and timeliness of information transfer to the DCF, its correctness according to the study protocol. It is worth monitoring the timeliness of the study documentation, since the file of the research center is no less important from the point of view of the regulator, who will evaluate the results of the entire work. To perform such tasks, the trial center monitor uses all possible methods of communication, from the usual cell phone and e-mail, to the organization of video conferences with many participants, in order to quickly and most widely discuss the emerging issue or find a solution to the problem.
In light of this epidemiological situation, X7 Research has taken the necessary steps to protect the health of our employees. Thanks to our well-established quality system, cloud-based IT solutions and competent planning, our employees carry out their work remotely while maintaining a high level of quality. This allows us to keep working on projects without interruption!