COVID-19 caused clinical trials to go digital at an incredible rate, with 97% of sponsors embracing remote monitoring.
Research sites and sponsors needed virtual environments for their ongoing trials. But more urgently, they needed a global digital infrastructure so they could test new vaccines.
To develop the COVID-19 vaccine, sponsors had to start up sites remotely on a global scale in days, not months.
After working with companies like Pfizer to enable vaccine studies for two years, Florence has discovered multiple tips that can help sponsors roll out future vaccine studies in a remote environment.
Here are five tips that can help sponsors quickly start up global vaccine study sites:
1. Moving Fast Requires Sites to Adopt Your Technology
For a vaccine study to get off the ground in a remote environment, sites need to adopt your remote platform. In too many cases, study startup is delayed by weeks or months because a site refuses to use the software or has trouble setting it up.
This is a headache for any study, but in a fast-moving vaccine race, this poses a significant roadblock.
Florence consistently delivers a 93% site adoption rate, with an average activation time of less than a week. We’ve earned the trust of 10,000+ research sites around the world, which allows us to achieve this industry-leading adoption rate.
2. Moving Fast Requires Sites to Use Your Software Regularly
Sites often adopt new technology but do their work outside of it, leaving sponsors confused about what’s going on. Because the tech is cumbersome, site staff will only upload documents at the last minute or after repeated requests from their sponsor.
These clunky workflows won’t work for any study, but especially not for vaccine studies that need to move at hyperspeed.
To keep trials moving, sponsors must know what documents have been received, viewed, updated, and signed at sites. Sites and sponsors must track their communications, and documents must be accessible 24/7. If the site doesn’t use the sponsor’s software, none of this will happen.
We solved this problem with an easy-to-use platform trusted by 10,000 of the most successful trial sites on the globe. Because our platform was designed with site workflows in mind, sites are far more likely to fully adopt the technology.
3. Moving Fast Requires Existing Site Technology Around the Globe
Vaccine studies need to pivot and add sites in “hotspot” areas quickly. Because a hotspot could happen anywhere, sponsors should look for technology that’s already used at trial sites around the globe.
Although regulations vary from country to country, sponsors can rapidly activate study sites as long as the underlying technology is already available in that nation.
Our global reach in 44 countries helps sponsors set up new study sites in regions where they need to bring vaccines to participants quickly.
4. Moving Fast Requires Long-Term Infrastructure
Sites often abandon the technology used in a clinical trial at the end of the study.
Essentially, sponsors must set up a completely new platform for every study–even when they partner with a site they’ve worked with before or a site they’re currently using for another study.
This leads to slow start-up times that could be prevented with an existing tech stack. Sponsors need to invest in long-term technical infrastructure at the study site to get studies moving more quickly.
By allowing the site to use one platform for all existing studies, Florence made starting new studies easier. Sponsors can now launch their next study in days instead of months.
5. Moving Fast Requires Integrations at the Site
Sponsor technology rarely integrates with existing site technologies, such as an EMR, a CTMS, eConsent, an IRB portal, or eSource. In the absence of integrations, the site operates in a “swivel chair,” moving data back and forth between systems.
This leads to delayed data, slowed studies, and compliance risks.
Source documents and data may be in the EMR, but the sponsor rarely has access to them and must wait on the site to manually copy the documents into another portal. This method doesn’t work well in traditional trials, but in vaccine studies that need to move quickly, it can lead to studies failing.
Through easy-to-use front-end and API integrations, Florence connects with existing site infrastructure to solve this problem. Our ePrinter module allows easy and direct capture of source documents from any EMR platform. The integrated environment also enables faster start-up, monitoring, and reporting.
We must quickly and safely test vaccines to help the world navigate COVID-19 and its new variants. At the same time, this new standard of rapidly advancing vaccine development requires thinking long-term.
The Florence platform provides integrated remote access to study sites globally for sponsors and CROs working to tackle vaccine development as well as advance medical cures globally.