Donawa Lifescience using remote monitoring during coronavirus pandemic

Donawa Lifescience is pleased to inform its clients that in relation to travel restrictions during the coronavirus pandemic, our Clinical Department has implemented an efficient procedure for remote monitoring visits.

European harmonized standards for clinical studies with medical devices or in vitro diagnostics, as well as the US Food and Drug Administration allow and, in some cases, encourage the implementation of remote monitoring procedures. This flexibility is very important to improve the effectiveness and efficiency in monitoring and, as usual, the subject’s confidentiality has to continue to be strictly protected.

The procedure for conducting a remote monitoring visit is almost the same that of an on-site visit, with the only difference that the clinical monitor is not physically present on site. During the remote monitoring visit the clinical monitor can continue to perform the following activities:

• reviewing the Case Report Form (CRF) using a central Electronic Data Capture (EDC) system
• communicating verbally with investigators and site staff
• reviewing study documentation that is sent to the monitor via email or fax, or else viewing documentation with the use of a webcam connected at the site, if its use is authorized
• providing site staff re-training addressing gaps in study management at site level

Sponsors should also keep in mind that remote monitoring visits have the following advantages:

• centralization of the monitoring process develops additional monitoring capabilities that can reduce the frequency of on-site monitoring, thereby reducing overall study costs
• review of the clinical data can be performed from any location
• data cleaning process and e-query management can be carried out in a timely manner
• site staff involvement in terms of time is reduced, making them more flexible

If you wish to receive further information regarding our monitoring services please review our monitoring webpage or get in touch via contact@donawa.com.