written by Funbi Ogundele
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written by Funbi Ogundele
May 29, 2020
In the clinical research industry, the two most important and critical factors to consider when reviewing subject data are the safety of study subjects and data integrity. The widespread impact of COVID-19, both in the US and around the globe, has led to a major disruption in face-to-face interactions. This prompted a sudden need for the ability to adapt around and create a new set of clinical procedures, processes, and safety standards, along with the recommendation to follow social distancing guidelines. As a result, sponsors, CROs, and clinical research sites are now feeling a growing sense of responsibility, industry pressure, and ethical obligation to our patients and staff to implement a number of procedures that ensure clinical trials are still able to progress, however possible.
Due to ongoing travel restrictions and site monitoring limitations, the feasibility of direct site visits has either drastically decreased or halted completely. Although the concept of remote monitoring is not new within the industry, many CROs have since started implementing this into their business plan, allowing Interim Monitoring Visits to continue remotely. However, as with many structural changes, it does not come without challenges. In fact, this alternative method of monitoring has shown to be something sites and CROs who otherwise did not yet have set procedures in place for, are implementing. This, in itself, adds new layers to consider when aiming to ensure subject safety, adequately reviewing source documents, and conducting investigational product accountability.
Site staff availability, along with site enrollment, during COVID-19 also raises questions when looking to recruit potential study participants. Many site staff are currently faced with the unfortunate reduction in hours, which inadvertently poses uncertainty when carrying out recruitment activities for a trial. These limitations created by the pandemic further raise concerns when determining whether study Investigators will be continually available to supervise the study at the site level as well as handle any safety issues that may arise.
Receiving, and accounting for, investigational product shipments or other time-sensitive study supplies is another factor in question from the drop in site staff availability. A major concern, especially for sponsors in clinical research during this time, is to ensure there are no supply chain disruptions, which can lead to IP shortages. Maintaining continued clinical supply availability, as well as continued operations of vendors, are essential to ensuring the safety of subjects.
Additional measures, often small but effective, have been implemented by Sponsors, CROs, and clinical research sites amidst the COVID-19 pandemic to ensure business continuity. Some of these include: Virtual meetings, working from home, telemedicine, virtual site visits, etc. These procedures set in place now will proactively streamline efficiency and steps needed in the future should another pandemic occur, while also minimizing risks and better ensuring both subject safety and trial integrity.
At MedSource, our mission is “to provide the best service and highest quality in the industry with a commitment to maintaining our corporate culture and company values.” We take our relationships with all clients seriously and we know that they count on us to deliver even in harsh times. As a result, we have implemented new procedures to ensure the seamless advancement of all clinical trials that we support.
We have put in place remote monitoring strategies to ensure that subject safety and data integrity are maintained. These include an IT solution that enables sites who do not use an Electronic Medical Record or a system that allows for safe remote review of subject data, to upload redacted source documents into a secured location with specified and limited access. In addition, we are implementing other IT solutions to encourage sites continued clinical activity by employing secure email for review and collection of regulatory documents. In some cases, we are also screen sharing with site personnel and engaging in creative ways to ensure continued monitoring of subject data.
Last but certainly not least, we are adhering to the FDA guidance for conducting clinical trials during COVID-19. We have procedures in place for the continued follow up and ongoing discussions with sites to capture any changes in site status and business as it relates to COVID-19. During these uncertain times, we at MedSource are driven to help innovatively advance clinical research by using our expertise and experience to come up with solutions to mitigate any potential risks to subjects.
Senior Clinical Research Associate, MedSource