Your Florence Expert

Technology doesn’t solve every problem, but as discussed in other articles in this resource library, there are many benefits to creating a compliant virtual environment.  Removing the need for physical access to investigator site file documents like regulatory and source documents is step one in overcoming the immediate interruption to your clinical research operations in light of COVID-19.

With this initial hurdle overcome, you are in a position to begin enabling additional advanced workflows such as eSignatures to avoid additional study delays. That brings us to the first stakeholder in your studies – your Principal Investigators.

This stakeholder is likely one of the most vulnerable to the disruption and waves felt across the life sciences industry. Many still operate medical practices that are likely overwhelmed during a time of health crisis. With an eISF or eRegulatory platform, your PIs will have access to your regulatory documentation from anywhere and at any time, so if they are operating from a home office or working late hours, he or she can utilize compliant eSignature tools like those we provide in eBinders.

There are other document management solutions that offer eSignature workflows as well. If you are considering these, be sure to confirm that the workflows they offer are verified 21 CFR Part 11 Compliant. Here is a comprehensive checklist to help walk you through this evaluation process and remove this burden. You may also want to consider future needs before making a drastic organizational change.

For example, perhaps you’ve made the decision to postpone non-vital clinical research and need a way to help your PI prioritize or narrow his or her focus on the studies that are moving forward. A software platform with in-app messaging, signature request features, task management and various advanced project management workflows will be crucial during this disruption and in the future. You will be able to  stay in constant communication with your PIs while maintaining the health of your site file, which brings us to the next critical stakeholder – your Sponsor and CRO monitors.

Your CRA and Sponsor Monitors for the first time in our recent history are being locked out of sites either based on a site-specific decision to protect patients and staff or because of travel restrictions that Sponsors or CROs are instituting.

In any event, the suspension of this vital element of clinical research has the potential to bring studies to a screeching halt. However, with an eISF or vritual document management solution in place, it is your opportunity to lead with action and give your monitors remote access to your source and regulatory documents.

And with a tool like eBinders, you will have additional security features like PHI redaction, permission controls (down to the document level to ensure only what they need to see is exposed) and QC collaboration features that meet the needs of communication and the goal of ensuring document quality and completeness.

As a technology-enabled research organization with remote monitoring-specific tools in place, you will be uniquely positioned to help ease this unprecedented setback.

Changes across the health sciences industry are happening faster than anyone could have anticipated. Communication and information exchange are likely happening in more channels than usual and people are understandably distracted.

Finding a way to streamline things like remote monitoring and team communication will help you ease the internal panic and sense of isolation that each of us is likely fighting to suppress. It is a time of rapid-fire exchanges related to study updates across stakeholders. By simplifying any pieces of this puzzle within your power, you are providing visibility across your team and stakeholders and enabling quick decision-making that will have far-reaching implications.

As we find ourselves slowly emerging from this crisis, you will have built a long-term strategy that allows for a more flexible and scalable study. And of notable importance, you will also be a go-to research organization that is highly respected and sought-after.