ICH GCP and ISO14155 defines the term monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).” Furthermore, the quality standards state “The sponsor should ensure that the trials are adequately monitored.”
It is clear, standards and technology used 20 years ago are no longer adequate today. However most clinical trials are still monitored as if it were the year 2000. This includes outdated monitoring practices.
Our team believes that the monitoring 20 years ago matched perfect with the requirements of the time. However, monitoring nowadays is significantly different. Internet, electronic tools, and a better understanding of risk management have brought to light the powerful process that is clinical monitoring. We work with eCRFs, ePro, eISF, eTMF, CTMS, eICF, IRT and many additional modern tools. These tools help us and our clients to oversee 97% of study data remotely. This reduces the need for resources that traditional on site monitoring and study site visits significantly increase. COVID19 has shown us that we must change our mindset to incorporate new remote working processes. Remote monitoring it is more than a possibility it is a necessity.
If you want to change your clinical monitoring to meet higher standards and keep up with today’s technology boom, contact us today!
E-Mail: info@gcp-service.com
