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 This includes outdated monitoring practices.
Internet, electronic software tools, and a better understanding of risk management overall are combined to implement the powerful oversight processes that are on site and remote clinical monitoring. We work with eCRFs, ePro, eISF, eTMF, CTMS, eICF, IRT and many other online tools to help our clients oversee 97% of study data remotely. This remote technology reduces the need for resources that traditional on site monitoring and study site visits significantly demand. COVID19 has forced a change in overall mindset and shown the world the need to incorporate new remote working processes. Remote monitoring it is more than a just possibility… it’s a necessity!
We use the technology of today to bring your study to its highest potential.
Contact us today!
E-Mail: info@gcp-service.com
