Insights Blog

Leveraging eRegulatory to Improve Remote Monitoring

Posted on May 3, 2018 9:57:43 AM
In this day and age, we are surrounded by technology. Everywhere you look, people are checking their phones in an effort to stay connected to their friends, family and workplace. In the clinical research world, advancements in technology represent an opportunity to improve efficiency. Remote monitoring is included in this category, enabling sponsors and CROs convenient access to site documentation.
From Burden to Opportunity

Remote monitoring technology initiated by sponsors often inflicts 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. However, sites are beginning to identify more efficient ways to enable remote monitoring. Empowered 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 research sites, 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 eased - reducing requests, saving time and eliminating burden that’s placed on regulatory staff.

Satisfied Sponsors

While initial resistance may occur, sponsors and CROs 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 the web-based system, allowing them to spend more time reviewing important patient data while on-site.

Recently, Complion held a community forum to discuss site initiated remote monitoring. The comments below ares commonly echoed by others 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!"

-- CRA, 2018 Complion Community Forum

“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 an eRegulatory solution, sites have the 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 your 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 an eRegulatory system is it’s searchability. Monitors can find what they’re looking for just by simply typing in a couple key words describing the document, saving them time, as well as cutting down on 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 we’ve learned from supporting over 60+ different clinical trial organizations from small single site research teams to large multi-site institutions.  

To learn more about Complion or to schedule a demonstration, visit https://resources.complion.com/demonstration

 

Topics: eRegulatory, Paperless Clinical Trials, Paperless Research Sites, 21 CFR Part 11, Remove Monitoring


Sydney Shepherd

Written by Sydney Shepherd

Sydney works with clinical research sites and site networks throughout the country to improve document management and workflows processes for increased efficiency and compliance.

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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