Data integrity and quality are integral to the success of a clinical trial. Clinical monitoring is an essential function that facilitates study conduct — to assure data quality and study integrity, and to reinforce compliance to protocols and regulatory guidelines. With the COVID-19 pandemic, there have been ramifications on clinical trial planning and conduct. Clinical monitors are now expected to conduct many activities remotely that were once performed on-site. The regulatory guidance recently issued by major authorities in response to the COVID-19 pandemic supports the use of central and remote monitoring programs to maintain oversight of clinical sites. To that end, clinical affairs teams must take into account the logistics, operations, systems, secure online platforms, robustness and - most importantly - assure the practicality of conducting remote clinical monitoring.
This webinar was brought by The Journal of Precision Medicine and the Precision Medicine Leaders' Summit.
Speaker:
• Andrew Crenshaw, Global CDx Discipline Director, IQVIA Laboratories
• Shirin Hasan, Associate Vice President, Global Clinical Affairs, Agilent Technologies
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