The Journal of Precision Medicine and the Precision Medicine Leaders’ Summits are delighted to bring you this complimentary webinar presented by Shirin Hasan of Agilent Technologies and Andrew Crenshaw of Q2 Solutions.
Data integrity and quality is integral to the success of a clinical trial. Clinical monitoring is an essential function that facilitates study conduct; to ensure data quality, 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 (including FDA and EMA) 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 ensure the practicality of conducting remote clinical monitoring. We must leverage our collective knowledge and experience to chart out business continuity best practices required to support clinical trials in this new business environment.
This discussion will outline how we have implemented these controls and mitigated the risks associated with remote clinical monitoring.
Associate Vice President,
Global Clinical Affairs
Global CDx Discipline Director, Q2 Solutions
Tom Fare, Ph.D.
The Journal of Precision Medicine