Authored and contributed to PharmaLeaders by Jeff Pool, VP of Revenue at Florence Healthcare
Failed remote site access and monitoring attempts have left study sites with a computer full of access portals, FTP logins, document vaults, and emails.
Why do sponsor remote site access and monitoring rollouts fail? Because the sponsor focuses on solving their access problems – not the workflow challenges of the sites.
The rapid rise1 of the Electronic Investigator Site File (eISF) as the foundation for remote site access solves this problem by providing equal benefit to the site and the sponsor – driving adoption and success across clinical trial stakeholders.
This centralization of documents, workflows, and processes provides sponsors a single point of access to the study site. While the benefits of remote site access for sponsors2 are clear, sites too now have a valuable tool at their disposal that provides five key benefits.
- Effortlessly enable monitor access.
At first, easier monitor access to trial data and documents may seem like only a benefit to the sponsor, but a deeper dive reveals how it is a win for the site when layered on top of an eISF.
“Onsite monitoring visits can waste a lot of time,” explains Chad Adams, Associate Director of Clinical Research at the University of Arizona Cancer Center. “The onsite experience necessitates time spent setting up the visit, calling back and forth, reserving rooms, and preparing physical binders. Then when the day arrives, often the entire day of the [Clinical Research Coordinator] CRC or Regulatory Coordinator is spent checking in and being a runner for that monitor. Every site CRC has many other important things they can be spending time on rather than sitting with the monitor, but they often times end up doing that during site monitoring visits.”
Fundamentally, remote monitoring built on top of an eISF platform helps keep studies moving forward by making access easy for the monitor and data exchange less time consuming for the research site.
Because the site is maintaining all of their content in the platform, from content creation to completion, there is no time wasted exchanging documents and data between the site and monitor.
- Avoid disruptions and re-purpose physical space.
Physical monitor visits require extensive coordination with the site to ensure vital study personnel, documentation, and room reservations. Sites must allocate space and provide a study “runner,” typically a CRC, who often spends an entire day retrieving documents. It’s not uncommon for one cancer center to have as many as fourteen rooms allocated to a single monitor visit.
“The space requirements are a huge problem,” explains Adams, “Our SOPs had to start restricting how often a monitor can be onsite because the demand for monitoring visits frequently exceeds the space capacity we can provide for them.”
Physical space is at a premium in a healthcare provider building, so minimizing space for monitors is a tangible and measurable win. Remote monitoring requires minimal site personnel disruption and no physical site-space needs.
- Maintain complete control over how monitors access data and documents.
eISF-based remote site monitoring platforms allow sites to control what access monitors have to their study documents – even if the sponsor is paying for the solution.
Purpose-built remote monitoring platforms allow the site to control who gets access to a binder or a document, how much they are allowed to see, and what they can do with that visibility.
Control also means that monitoring can take place outside of regular business hours. A site can easily accommodate a monitor two time zones over working outside local business hours.
- Gain visibility into monitor visits.
During an in-person monitoring visit, the site staff can, at best, infer what the monitor is interested in and review the official monitor summary report to give them insights into how the monitor measures their site performance.
eISF + Remote Site Access platforms give the site deep visibility into the monitor visit through a clear record of what each monitor does in the system. This tracking capability allows research teams to more tactically understand what areas to focus on or improve for future monitoring visits with little effort.
- Increase trial speed.
Onsite monitoring visits create a time burden for the site and sponsor. By minimizing travel and communication delays, remote site monitoring increases the overall trial speed.
“Remote monitoring allows a site to turn on access in a matter of moments and as frequently as the monitor needs,” explains Adams. “Software allows for a much more fluid operational flow, and the issues of distance and logistics go away. This speeds everything up.”
Remote technology allows actions to happen near real-time, document queries to launch seamlessly, and immediate task completion.
You can take action now:
The benefits of remote site monitoring to the study site have been murky at best over the last decade. Now, though, study sites are finding significant value in moving their internal operations to an eISF + Remote Site Access platform.
Site leadership, you have an opportunity to invest in an eISF platform now to:
- Be “in the driver’s seat” of how they will collaborate remotely with sponsors and CROs
- Optimize internal workflows across studies and sites
- Be a preferred study site partner for sponsors and CROs requiring remote site access
Sponsor clinical operations leaders, you have an opportunity now to accelerate operations with remote site access through a platform that solves site workflow challenges: ensuring adoption and long-term success.
If you do not have an eISF + Remote Site Access platform in place today, it is important to begin researching solutions so you can take advantage of this shift in 2021.
Learn more about Florence Healthcare at https://florencehc.com/.