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June 16, 2020
Vice President of Clinical Operations at MedSource, Scott Hannas, oversees responsibility for Clinical Operations, Medical Affairs, Biometrics (Statistics/Data Management), and other corporate operations. Scott joined the MedSource team, stemming from an accomplished prior 27-year career at Eli Lilly and Company. Having been at MedSource for just over a year, he’s credited with expertise maneuvering within both pharmaceutical/sponsor and CRO environments, and now, can add uncharted territory under his belt from the continued COVID-19 pandemic.
Like many other industries and businesses, the Coronavirus has created significant disruption within the clinical research industry. Unfortunately, the sudden internal hit economically to employees was only half the battle. It also meant an immediate impact and significant slow-down in clinical trials globally, and affected both new and ongoing clinical research efforts.
When asked his thoughts on conducting clinical trials in the midst of this COVID-19 pandemic, Scott had our clients, patients, studies, and other external factors in mind. With other CROs also looking for answers, he knows the importance of stepping up as an industry leader and takes priority in effectively communicating a solution-based approach to explaining the steps we’re taking to help combat COVID-19 challenges during this unprecedented time.
His response is below:
“At MedSource we are a values-driven organization, and as such we are doing everything we can to assist all stakeholders with moving clinical trials forward during this COVID-19 pandemic. We have a sense of urgency because we understand that our patients, our sponsors and our sites are counting on us! We are striving to serve as advocates for our sponsors and our sites to creatively find remote monitoring solutions, so that we can continue to protect patient safety and the integrity of the data.
Specifically, we have offered an IT solution that allows for a site to upload redacted data to a secure One Drive location that has restricted access. Only specific site personnel and our CRA have a limited time access that allows for a remote monitoring solution where a site does not have one in place. Many sites either do not have an Electronic Medical Record or a system that allows direct access for remote monitoring capability. We are also engaging in other site-initiated IT solutions that don’t require the redaction of data, utilizing secure email in some cases, and participating in screen sharing with site personnel that all serve as creative ways to gain access for remote monitoring.
Finally, we are operating in a manner that adheres to the FDA guidance for conducting clinical trials during this COVID-19 pandemic and are appropriately documenting any changes in normal processes. This is such a unique time in history, so we at MedSource are collectively utilizing our experience and operational expertise to help lead clinical research forward in an innovative manner.“
MedSource is proud to be actively working on an innovative COVID-19 clinical study and part of the race for a cure.