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:
Sponsors should also keep in mind that remote monitoring visits have the following advantages:
If you wish to receive further information regarding our monitoring services please review our monitoring webpage or get in touch via firstname.lastname@example.org.