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Decentralization of Clinical Trials Requires Digitization of Clinical Trials

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Is the Industry Wired for This Revolution?

by Blake Adams, Senior VP of Marketing, Florence

You are almost guaranteed to have heard or seen the word “decentralized” in the last year if you’ve been to a clinical research conference, looked at vendor emails, or glanced at any materials related to clinical research technology.

There is a good reason for this, since decentralization focuses on patient-centricity; something that became increasingly relevant during the pandemic as access to clinical trial sites for patients, clinicians and sponsors was restricted.

Decentralized trials allow elements of the study to be conducted at traditional sites such as hospitals or academic medical centers, at non-traditional sites such as primary care practices, pharmacies and labs, and through virtual methods such as telehealth visits, wearables, apps and home visits.

The end result is greater patient-centricity, higher enrollment, fewer drop-outs, and a faster study timeline.

Right now, decentralized trials are seeing a lot of innovation, with new companies appearing overnight to provide virtual trial solutions or direct-to-patient trials. 

However, the rush to decentralize with a primary focus on the sponsor-to-patient link has caused many organizations to overlook the first link that must be digitized: the sponsor/CRO to study site link.


Why Do Sites and Sponsors Need Digital Links to Each Other? 

Survey data from WCG Avoca shows that 89% of clinical trials will continue to be hybrid, meaning a mix of physical site visits and virtual connections.

New technologies fighting for a piece of the decentralized trials ecosystem have pushed many sites to the breaking point, with the average decentralized readiness of 200 senior clinical research site leaders ranking at a 5 on a scale of 1 to 10

Despite sponsors ranking moving to decentralized tools as a top priority, 60% of sites only use decentralized tools in less than 10% of their studies, and 30% of all respondents do not use them at all.

Sites that are deploying these technologies struggle with how many platforms they have to manage. On average, they must log into over seven solutions for every individual study, resulting in hundreds of logins for sites managing a large study portfolio.

While more technology doesn’t always mean a negative impact on operations, 40% of sites indicate that integrating systems is their biggest challenge. In fact, over 50% of source data review and verification activities are still done via paper-based or “over the shoulder” methods on-site.

What does this all mean? 

Unless the critical link between the sponsor and the site is fully digitized, the new models of research that depend on digital workflows will not succeed.

Digitalization does not mean that a site uploads a document after it has been finalized on their end. Using that method, a sponsor has no visibility into status, barriers, process risks, or study slow-downs and is unable to connect the site’s results with the rest of the study ecosystem.

The digitization of the site-to-sponsor link requires an end-to-end, always-on workflow. Sites and sponsors need one system where documents are:

  • Created
  • Completed
  • Reviewed
  • QCed
  • Exchanged
  • Synced

How can sponsors and CROs digitize their network?

Once sponsors and CROs realize that they need to digitize their site network, how can they make it happen? 

Sponsors have two options: 

1. Tap into existing eISF software at the study site

Many clinical research sites have invested in their own electronic Investigator Site File software over the past decade. They now manage documents in the system from creation to completion and quality control. 

As of March 2022, 12,000 sites manage their eISF on Florence eBinders. Through Florence’s SiteLink, sponsors are tapping into this network to digitize the site-sponsor workflow.

2. Deploy an eISF infrastructure to the site

Sponsors can stay connected throughout the process and help the site finish its work faster. If the site does not yet have an eISF platform, such as Florence eBinders, sponsors must provide it so the site can do all its work in one place.


How is the digitized sponsor-site link helping?

Sponsors who use Florence SiteLink to connect with and deploy the eISF to their study sites are seeing immediate and lasting impact.

1. Greater CRA Efficiency

A top-3 CRO increased each CRA’s average visits from two to 52 per week using remote access. CRAs are able to get more done, focus on important tasks, and reduce on-site visits.

Making clinical trials more efficient is especially essential because the clinical trial industry is expected to grow 5.8% each year until 2030. It’s difficult for sponsors and CROs to hire CRAs fast enough to keep up with this demand, so the alternative is to help make existing CRAs more efficient. 

Remote monitoring tools, like SiteLink, can help. 66% of CRAs spend fewer hours on repetitive tasks when using remote monitoring, and 77% can collect essential site documents faster.

2. Scalability of Infrastructure

While most study software requires setting up from scratch every time, once a site migrates to eBinders, their infrastructure is set for all future studies. That infrastructure includes their essential documents and user controls. A top-5 pharma company scaled from 4 to 45 studies on our platform in a matter of months.

3. Faster Site Activation Timelines

Because the site already has the infrastructure in place and those sites who don’t benefit from the network effect, sponsors working with Florence SiteLink see 93%+ activation rates in a matter of weeks.

4. Less Risk of CRA Turnover

CRA turnover rates consistently hover around 30%. When a CRA change happens, there is a window of risk where the documents and communications with the site are being handed over – or worse, having to be recollected and established.

Sponsors on SiteLink can easily switch CRAs in and out of sites because all of the documents and communications are digitized on a single platform, not living in emails, hard drives, and storage boxes.  71% of CRAs said it was easier to replace other CRAs when using SiteLink. When CRAs have easy access to pre-existing documents and data, trials don’t have to slow down as much when a CRA leaves.

5. Flexibility of Site Selection

Activating a new site can happen in days with SiteLink. Because tens of thousands of investigators are already connected to the platform, it’s simple to add a new site to the study or transfer a patient to another location. 

This is especially invaluable when coordinating centers or sponsors want to work with frontier sites: new-to-research sites like pharmacies, community clinics, and labs. These sites often don’t have experienced research staff or investigators. With software like SiteLink, experienced coordinating centers can check in on frontier sites and ensure their regulatory documents and data are compliant and complete.

6. A Foundation for Decentralization

Ultimately, sponsors are building a foundation for decentralized trials. Through our existing relationships with decentralized trial platforms, we are linking real-world sites into the virtual site ecosystem, creating a mesh network of patient access points.


Why Sites and Sponsors Should Embrace Decentralization and Digitization

If you’re not prioritizing digitizing the link between the sponsor and the site, now is the time to do it. Florence Healthcare is the industry standard for this digital link, and our team can give you a free consultation on building a strategy to digitize your workflows with study sites.

Learn more about Florence SiteLink or request a demo here.