Helping Your Research Site Go Paperless
In November 2021, Florence hosted over 200 clinical research professionals at the first-ever Innovation Summit to discuss the latest trends in clinical trials.
Going paperless was the most popular topic, with dozens of clinical research experts sharing how they use technology to run their trials.
From these discussions, we picked up on three common concerns about going paperless:
- The impact on operations: Does going paperless actually increase efficiency?
- The ROI: Is going paperless worth the cost? If yes, how do you show the benefits to sponsors and CROs?
- The effect on staff: How do clinical research teams make technology work for them instead of against them?
Digital technology can make research sites more efficient and produce a great ROI—but only if the technology is intuitive and staff members are well-trained on how to use it.
Here are a few tips we gathered from the clinical research professionals at our summit. With these strategies, sites can go paperless efficiently and compliantly.
The impact of going paperless on operations
The drug development process can take up to 10 years. The more time clinical research professionals can save on operations, the faster they can get new drugs to the patients who need them.
The clinical research experts at our summit suggested that technology can help their teams communicate and manage documents faster. But the benefits don’t stop there. The right software can also help clinical research teams stay compliant.
How going paperless improves communication
To save time, clinical research teams need standard protocols for how they exchange documents and collaborate on changes.
The keyword here is “standard.”
When adopting technology, sites need to first make sure the technology offers standard ways to communicate with monitors and keep track of where documents are and when they’ve been updated. These features may include audit trials, version control, the ability to assign tasks, and monitor communication modules.
Your technology should track:
- Document updates (ex. protocol amendments, ICF templates, investigator credentials)
- Changes in study status (ex. budget approved, study closeout, enrollment changes)
- Missing documents or tasks (ex. signature pending, missing PDF, expired training)
- Remote monitoring findings (ex. query to be reconciled, document approval)
With these features, you can communicate with your team and your sponsor more quickly. One of our clients used technology to accelerate their study start-up time by 49.2%.
But if you want to speed up your workflows while keeping your data safe, you need access controls and Standard Operating Procedures (SOPs) that make compliance easier.
How going paperless improves compliance
When your site goes paperless, you’ll need to update your Standard Operating Procedures (SOPs).
Having clear, updated SOPs will ease the burden on your team, eliminate repetitive or duplicate work, and prevent compliance risks from missing or outdated information.
The good news? A reliable clinical trial vendor will help you create new SOPs that make staying compliant easy for your team.
Digital technology also makes it easier to control many aspects of compliance, like:
- Who can access the documents: Roles and permissions ensure internal team members, monitors, and auditors can only see the documents and data they’re authorized to.
- What types of documents can be stored in the software: If you choose clinical trial software with integrations, you can import documents from your CTMS, EHR, or ePRO systems into one secure location.
- Where will the documents be housed, and is it secure and compliant: Choose an eISF or an eTMF designed for clinical trials to ensure that your software complies with ICH GCP and GDPR standards as well as FDA and other national regulations.
- When will the documents be accessed: With digital technology, monitors can check for missing documents and data often, instead of only when they can make it to the site. This lets you update your documents quickly and avoid major compliance issues.
- How will the documents be accessed: Technology can protect your documents and data with secure log-ins and audit trails that show when a document has been updated and by who.
With all of these technology features, you can go paperless and make it easier for your site to stay compliant at the same time.
The ROI of going paperless
70% of clinical trials experience start-up delays, and study start-up can cost as much as $8.5 million.
By cutting down on study start-up time, technology could save sponsors hundreds of thousands of dollars as well as weeks of time. Sites could even win more studies by showing sponsors that they already have technology in place.
These benefits alone will give sites a strong ROI if they go paperless. But going paperless also enables remote monitoring, which comes with its own set of benefits.
97% of sponsors now use at least one form of remote monitoring. If sites want to remain competitive, they’ll need to offer sponsors the ability to see their documents remotely. Sites should be able to store documents and data in a software program they control and give their sponsors permission to view only the documents they need to see.
Clinical research associates (CRAs) can also save substantial amounts of time and money by engaging in remote monitoring. Instead of spending hours on a plane or in a car every time they need to review documents, they can review most data remotely and only travel to the site for essential visits.
Although many sites want to experience the benefits of going paperless, you can’t see the full ROI of new technology unless your team is well-trained and comfortable using software. That’s why training is a critical part of adopting new technology.
The effect of going paperless on site staff
Clinical research coordinators and associates will always play a vital role in clinical trials. But as technology becomes more popular, the ability to use tech will become more valuable than the ability to complete paperwork.
A good software vendor will provide in-depth training on how to use their software and help your company build a change management plan. But many of the clinical research professionals at our Innovation Summit also opted for industry-recognized individual education to help them get ahead in their careers.
An in-depth understanding of clinical research trends can help you become more efficient, take on new responsibilities, and identify yourself as a leader. This includes training in digital research.
Lead the way to a paperless future with Florence’s Digital Research Certification Program
Florence created a vendor-neutral digital research program to help sites become more comfortable with going paperless.
Our Fundamentals of Digital Research certification covers topics like change management, compliance considerations, standard operating procedures, and regulations around digital research.
When you complete the Fundamentals of Digital Research course, you’ll receive a certification in:
- Knowing clinical research technology definitions and industry trends.
- Understanding the landscape of digital research technology.
- Developing standard operating procedures for digital research.
- Building protection and privacy into your tech from the start.
- Executing a technology change management master plan.
In addition to the certification program, the Florence Digital Research Community offers roundtables, webinars, panel discussions, online forums, and events to help leaders in the field advance their knowledge of digital trials. Our community includes more than 875 clinical research professionals (as of November 2021).
Prepare for a paperless transformation
Going paperless can help clinical research sites become more efficient, save time and money, and stay compliant. But in order to see these benefits, clinical research professionals have to get ready for a digital research transformation.
Learn how to make clinical trial technology work for your team’s paperless journey by taking the free Fundamentals of Digital Research course.