Study monitoring is an essential element of medical device GCP and study conduct outlined in the IVDR, irrespective of the stage of clinical development of your therapy asset or your in vitro diagnostic medical device.

Study monitoring assures the rights, safety and welfare of study participants as well as ensuring the highest quality data for your programme decision-making and/or regulatory submissions.

As IVD technologies and assays become more complex meaning that large data sets are being generated coupled with an increased focus on study conduct and data integrity from regulatory authorities, the development of an appropriate risk-based study monitoring programme becomes ever more challenging for IND/IMP and Dx study sponsors.

ARC Regulatory's Head of Global Clinical Operations and Senior Clinical Project Manager discusses what a successful global IVD / CDx study monitoring programme look like, the common challenges faced and solutions to overcome them as well as the considerations for successful collaborations with your laboratory and study monitoring partners.