As decentralized clinical trials become more popular, many sites and sponsors have begun to wonder how they can adopt decentralized methods without sacrificing compliance or efficiency.
The COVID-19 pandemic proved that patients can participate in clinical trials using video calls, apps, wearable devices, and visits to their local physician, not just by visiting the research site in person.
However, these hybrid decentralized trials work best when there are software integrations between research sites and their sponsors. When that connection exists, research sites can receive accurate source data from doctor’s offices, pharmacies, and patients and send that data and their regulatory documents to their sponsor remotely.
So how do you set up the site-sponsor connection and make decentralized trials effective and secure?
You can start by reading this post. Then check out Florence’s interoperability webinar for more insights on how sites and sponsors can work together to make decentralized trials work.
Establishing the Site-Sponsor Connection through Software Integrations
According to a June 2021 study by WCG, 97% of research sites expected to use at least one remote monitoring tool to communicate with their sponsor. This is great news for sites interested in decentralized trials because it means they will have plenty of technology at their disposal to help them connect with sponsors.
The right software for site-sponsor connection will offer the following benefits:
- Real-time monitoring
- Instant document and data exchange
- Automated workflows
- Remote Source Data Verification (SDV)
- Virtual study start-up
- Expansion of site network
Real-time monitoring will allow sponsors to check on sites’ progress without having to visit the site in person every time. Sites can upload their regulatory documents, source data, lab results, consent forms, and all other essential documents to a secure online database.
Sponsors can then view documents without waiting on emails or faxes and can electronically share eTMF documents with sites as needed.
In addition to letting you share documents, well-integrated software lets you set up automated workflows. Clinical research staff will no longer have to spend hours manually transferring data from an electronic data capture system (EDC) or electronic health record (EHR) to the electronic investigator site file (eISF.)
If you choose software systems that can integrate, you can link your programs and automatically transfer data between them.
Technology can also enable Remote Source Data Review (SDR) and Remote Source Data Verification (SDV), two of the most popular features of decentralized trials. In fact, more than 94% of research sites expressed interest in both.
Sites love being able to instantly share up-to-date source data with sponsors, and sponsors love not having to wait on emails or faxes every time they need to check on source data.
Clinical trial software can also shorten study start-up times. Research sites and sponsors can pass essential documentation back and forth and sign it through a single secure online system. This lets sponsors or coordinating centers expand their site network by working with sites located in different states or countries.
How Research Sites Can Prepare for Decentralized Trials
After working with more than 10,000 study sites, Florence has come up with a few steps to help sites connect with their sponsors and prepare for decentralized trials.
1. Find the right software.
The right software will be purpose-built for clinical trials and will be able to integrate with other eClinical systems. Software programs that weren’t designed for clinical trials, like online drives or email, often aren’t secure enough to comply with FDA CFR Part 11 or GDPR.
The eClinical software you choose should also have the ability to integrate with other programs so you don’t waste time transferring data from one system to another. Software programs with open APIs can easily integrate with programs from other vendors.
When you’re researching decentralized clinical trial technology, make sure you ask each vendor whether their software has an open API.
2. Update your SOPs.
If you want to incorporate technology into your clinical trials, you need to make sure you update your standard operating procedures (SOPs) to accommodate these changes.
Your eClinical vendor should help you create SOPs that follow all ICH GCP, FDA, GDPR, and other relevant regulations so you won’t have to worry about whether they’re compliant.
3. Train your staff.
Your vendor should also help you teach your staff the skills they’ll need to operate new software. The software vendor can send in an implementation team to train people from your site. Those people will then become subject experts who can teach other staff to use the software.
You may also want to ask software vendors whether they offer online training videos, a help center, or a customer support team to assist your staff.
Our guide to eRegulatory implementations provides valuable tips about training your team to use new decentralized technology.
How Sponsors and CROs Can Prepare for Decentralized Trials
To run decentralized trials, sponsors and CROs need to connect to research sites all over the country or even the world. This connection is only possible if you choose software that sites are happy to adopt.
When implementing new technology, CROs and sponsors should search for systems that are designed with sites’ needs in mind. Ask the software vendor if they work with sites frequently, because some vendors only focus on the sponsor and CRO space.
Ideally, you could let research sites help choose the software so they have a sense of ownership and autonomy.
That said, you also want software that integrates with the technology you already have. No one hopes to spend hours manually transferring documents between systems. The key to decentralized trials is finding flexible, open API software designed for end-users.
Benefits of Decentralized Trial Technology for Sites
Adopting well-integrated decentralized clinical trial software can help sites speed up their clinical trials. Florence has seen research sites create their start-up study documents 40% faster with the help of our software.
Once the study is up and running, your clinical trial software can also provide a single place for you to check on tasks that need to be completed and documents that need to be signed.
Another benefit of clinical trial software, especially during decentralized trials, is that you can collect source data in a single location. During decentralized trials, data may pour in from local doctors’ offices, pharmacies, and participants’ homes as well as from research sites. With all this source data, research sites need clinical trial software that can integrate with their electronic health records (EHR) and pull in the data automatically.
Effective clinical trial software will also offer built-in encryption and redaction tools so sites can keep their source data secure and compliant when sharing it with their sponsors.
Show your sponsors all of the documents and data they need in real-time while preventing them from seeing any information that would violate FDA, GDPR, ICH GCP, or other relevant regulations.
Benefits of Decentralized Trial Technology for Sponsors and CROs
With a strong connection to the research site, sponsors and CROs can engage in remote site monitoring, a core component of decentralized trials.
Just log into a clinical research program that’s integrated with your sites’ programs, like Florence SiteLink™, and see your sites’ latest regulatory documents and source data at a glance.
Having a direct connection to sites’ eISFs lets you determine which documents are missing or incomplete before an audit occurs. You can even set up study reports and daily alerts to help you correct problems and remain in compliance.
Enabling Decentralized Clinical Trials with Site-Sponsor Connection
Decentralized clinical trials can give research sites, CROs, and sponsors access to more data and reach patients who may not ordinarily participate in trials. But adopting new technology and new procedures can be intimidating.
At Florence, we believe the first step to effective decentralized trials is establishing a strong link between sponsors and sites through secure, remote technology.
If you want to learn more about how to establish this link, check out our recent webinar for sponsors, CROs, and research sites.