It has been challenging to meet deadlines and milestones for the clinical trials where patient availability has decreased and due to limited support the clinical trials have been reduced to the minimum where possible.
Nevertheless, patient support and follow-up continues for safety and health reasons and a skeleton study crew is always available. In addition, authorities have recognized that study conduct monitoring and timelines have changed and accepted this. Remote monitoring of the study data based upon a risk assessment of the site capabilities and competence provides an ongoing confirmation of the study status and data quality.
Trial submissions and approvals have not been affected as much of the work is managed online nowadays (the need for 20 copies of submission documentation has long been abandoned).
In order to meet the demands and milestones for the medical device companies who are in the process of obtaining clinical data, it is still worth moving forward and already submit to the Ethics Committees and Competent Authorities for clinical trial approval.
The flexibility, competence and solution driven mentality shows that there are solutions for running clinical trials, even in a challenging time such as the CoVid-19 pandemic.
MedQ Consultants B.V.