There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus.
But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual.
Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one.
Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general.
All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained.
Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation:
In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century.
We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future:
Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact to the management of clinical trials.
What do you think about modernizing clinical trial monitoring? Please send me your thoughts at connectwithandrea@teckro.com