Leveraging eRegulatory to Improve Remote Monitoring

By: Complion

Remote monitoringIn this age of technology, every aspect of our lives is based on information and computerization.

We’re constantly checking our cell phones, posting to social media platforms, or streaming news and other media. In the clinical research world, advancements in technology represent an opportunity to improve efficiency. One such example is remote monitoring which enables sponsors and CROs convenient access to site documentation.

But, remote monitoring technology initiated by sponsors can often inflict additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. Fortunately, sites are beginning to identify more efficient ways to enable remote monitoring. Empowered research sites are taking control and initiating technology from their side to enhance collaboration with sponsors and streamline processes, ultimately lifting their day-to-day burden.

Reduce Redundancy, Increase Efficiency

For the research site, remote monitoring allows for positive changes to be made. When using a 21 CFR-compliant eRegulatory system like Complion, sites can provide monitors direct access to their electronic binders — eliminating the need for a double upload into a portal. Sites maintain control of their documents, allowing monitors to view them in a “self-serve” manner with restricted, read-only access settings. Sites can also control the monitor’s window of entry, enabling or restricting access for a period of time. Regular correspondence with monitors can become redundant and time consuming. With this type of remote monitoring, correspondence is streamlined which reduces requests, saves time and eliminates burden placed on regulatory staff.

Satisfied Sponsors

While there may be initial resistance from sponsors and CROs, both groups benefit from the ability to get what they need in a faster, more cost-efficient manner. Additionally, when site visits are necessary, monitors have the ability to prep in advance by using Complion’s cloud-based system, allowing them to spend more time reviewing important patient data while on site.

When Complion held a community forum to discuss site-initiated remote monitoring, here are some comments echoed by other sites and monitors:

“This has made my life easier. Regulatory reconciliation takes up a lot on-site time. This is stressful when I also need to perform SDV on patients within a limited amount of time. I appreciate the fact that the site can give me access a few days before and after my visit so I can review the Regulatory binder remotely. This is fantastic!”

– Anonymous CRA

“Our monitors like [Complion] because they can get what they need and see the narrative of an entire trial from beginning to end without coming onsite.”

– Stephanie Cardenas, LVN, Research Coordinator, South Texas Cardiovascular Consultants

Improved Standardization. With Complion’s eRegulatory solution, sites have an opportunity to standardize their binder template and ensure the standard is followed consistently. Rather than trying to maintain different templates passed down by sponsors, sites have the opportunity to create their own. Standard binder templates that are crafted to meet that site’s needs aid in making regulatory personnel more organized and help both parties work more efficiently and effectively.

Enhanced Searchability. One of the additional advantages of Complion’s platform is its searchability. Monitors can find what they’re looking for just by simply typing in a couple key words describing the document. This saves them time as well as reduces redundant correspondence with sites when looking for a particular document. Sponsor-initiated binder templates are no longer necessary due to the ease of searchability.

Finding the Right Partner

Transitioning away from paper binders and shared network drives into a purpose-based eRegulatory system can seem like a daunting process — but with the right partner, it doesn’t have to be. Complion’s Customer Success team partners with sites to support staff and monitors through training, education, and the development of policies and SOPs. We work with research institutions to discover their goals and needs for their particular binders, sharing best practices learned from supporting more than 60 different clinical trial organizations ranging from small single site research teams to large multi-site institutions.

To learn more about how partnering with Complion can improve your remote monitoring, why not schedule a demo with one of our team.

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