The study start-up process overflows with important but stressful tasks. Research sites need to determine whether a study is feasible and convince a sponsor to select them for the study. Then sites need to recruit eligible patients, create and complete all of their regulatory documents, and assemble their Investigator Site Files before the sponsor’s deadlines.
Given how much pressure the study start-up process puts on sites, it’s no wonder that 70% of clinical trials experience start-up delays. But some of Florence’s customers have managed to reduce their start-up time by 40% by embracing software. Many of these success stories come from coordinating centers that run multi-site trials throughout their healthcare system.
Sites can reduce study start-up time with intuitive, well-organized software for their regulatory documents. And ideally, coordinating centers can use the same software to standardize study start-up across all of their sites. Here’s how.
Using eISFs and eTMFs During Study Start-Up
The Florence team typically breaks the study start-up process into the following phases:
1. Investigator Meeting
2. Regulatory Document Collection/Submission
3. Provision of Supplies/Equipment to Sites
4. Recruitment of Patients
5. TMF Setup/Implementation
6. System Operational
7. Site Initiation
Software mostly helps with the Regulatory Document Collection/Submission, Recruitment of Patients, TMF Setup/Implementation, and System Operational phases of study start-up.
Research sites can use an eISF (electronic Investigator Site File) for their Regulatory Document Collection/Submission. An eISF allows sites to store and share their documents online. You won’t have to waste time printing, scanning, and emailing documents to sponsors or CROs during study start-up.
Sites can also use software to help with the Recruitment of Patients. Some programs use AI to help research sites find patients who meet a study’s qualification criteria. Others let patients search for clinical trials near them.
The TMF Setup/Implementation phase is usually handled by sponsors or CROs. Many of them use eTMFs (electronic Trial Master Files) for this purpose. But the key to efficient study start-up is having an eTMF and an eISF that can work together. That way, sponsors, CROs, and coordinating centers can instantly see their sites’ updated documents and add them to the eTMF.
During the System Operational phase, your goal should be to make sure all of your technology is set up, including an eISF, eTMF, and an EDC (electronic data capture) system. You want all of your software ready to use before you dive head-first into a trial, because technology can make study start-up and the study as a whole more efficient and more compliant.
Benefits of Tech for Study Start-Up
The study start-up process gets slowed down by document creation and updates, waiting on signatures, and confusion over which tasks or documents still need to be completed.
One of our site customers told us that when they used paper, they had a 65% pass rate for their initial regulatory submission. That means they needed to redo the submission one-third of the time due to missing or incomplete documents. With an electronic system, their pass rate rose to 99%.
Here are a few ways tech can help with the regulatory submission during study start-up:
Creating and Updating Documents Easily
With electronic ISFs, clinical research teams can use templates to create documents more easily. Florence also offers fillable forms so you can create documents entirely online: no printing, scanning, and uploading.
It’s also easier to update documents using an electronic system. With central document linking, you can change one document and have those changes show up everywhere that document is stored within the same system. So if a site makes changes to a document in one folder, and their sponsor has that same document stored in a different folder, the document will automatically update in both places.
This helps with compliance, since it ensures that sponsors, CROs, and coordinating centers always have the latest versions of their sites’ documents.
Gathering Electronic Signatures
The ability to sign forms from a computer or phone can save hours for PIs and clinical research staff during the study start-up process. Clinical research assistants will no longer have to run or drive across sprawling medical complexes to hunt down overwhelmed principal investigators and beg them to sign paper forms in person.
Principal investigators are too busy with research and patient care to devote large chunks of time to signing paper forms. Electronic software lets them sign wherever is convenient for them: at Starbucks, from their couch, or even from the train. Software can also help them keep track of what forms they need to sign and who asked for them. All of their tasks and requests will be listed on a single webpage.
However, electronic signatures need to be 21 CFR Part 11 compliant. That’s why it’s important to use software made specifically for clinical trials instead of software designed just for electronic signatures. For more about Part 11 compliance, see our downloadable checklist.
Establishing Logs
If you’ve worked at a research site, you’ve run into confusing trial logs covered in different people’s handwriting. Setting up logs online keeps them neat and easy to read, so research staff aren’t left wondering who’s in charge of a specific task during start-up.
When you use eLogs, you’ll also be able to look back at older versions of the log while having the newest information displayed. Clear, legible logs streamline the study start-up process and the study as a whole.
Keeping Projects on Track and Managing Priorities
Regulatory submissions involve so many documents, forms, and signatures that even experienced clinical researchers can become overwhelmed. eClinical software allows you to assign tasks to specific team members so they can log in and see exactly which documents they need to create, review or sign.
This software also lets you create placeholders to indicate where staff should upload specific documents, and you can add due dates so people know which tasks to prioritize.
As a bonus, technology can help sites analyze where they run into delays in the study start-up process. Many software programs can create reports that show how long it’s taken people or sites to complete documents. If one type of document or one department often causes delays, the site can solve the problem so study start-up can move faster.
If you’d like specific details about how Florence eBinders, our eISF, helps with study start-up, check out this article.
Using Tech to Streamline Multi-Site Start-Up
The study start-up process is even more complicated for multi-site studies. The coordinating center has to gather regulatory documents from a network of sites that could all use different document management systems.
If several sites are using paper binders while others are using various online drives and dropboxes, the coordinating center’s team will waste hours ensuring each site has all of the correct documents.
That’s why it’s helpful to have a software program that can be deployed across sites and that the coordinating center can access. If all of the sites are using the same program, the coordinating center can log in and see all of their documents in one place. This remote site access has improved study start-up times for our clients by as much as 40%.
Taking Advantage of Templates
Multicenter trials can save time with standardized binder and folder setups. With the right clinical trial software, the coordinating center can create a template for how binders and folders should be arranged and send it to all of their sites. The center can even build placeholders so sites know exactly where to upload each of their documents.
For example, one of our partners, Elligo Health Research, decided to use Florence to remotely release study start-up kits. Sites used these start-up templates to organize their data and documents, leading to 320,000 successful document collection events.
Using Site Overview for Study Start-Up
In multi-site studies, the coordinating center needs to keep track of how far each site is in the start-up process. Remote site access allows coordinating center staff to see how many tasks each site has completed, which documents are missing, and what each site still needs to do.
When the staff at the coordinating center can check on their sites’ progress online, they save time and money that would be spent traveling to each site. They also won’t have to send a flurry of emails to explain which documents are missing or which tasks need to be done. Instead, they can set up an alert within the software system that will show site staff exactly which task to complete.
Remaining Compliant
Compliance errors can slow down or derail the study start-up process. To prevent these errors from happening, coordinating centers need to perform compliance checks on their sites’ data.
This could mean looking at everything from source documents to protocols, case report forms, participant inclusion/exclusion criteria, withdrawal/stopping standards, and informed consent documents. Coordinating centers can perform these checks more quickly with remote access to their sites’ documents and data.
Keeping Sites Happy
We’ve talked to many research sites about how frustrating it is when a coordinating center, sponsor, or CRO forces them to use software that doesn’t match their usual workflows. Research professionals may benefit from general digital research training that they can apply to new software programs. But coordinating centers also need to look for site-first software.
Site-first software is designed with research sites’ needs and requests in mind. It will have a clean, intuitive interface, won’t take a long time to understand, and will be flexible enough that sites can customize it to their needs. If the software is easy to use, the implementation process won’t take as long and sites will experience faster study start-up times, which benefits coordinating centers and sponsors as well.
Improving the Study Start-Up Process
The study start-up process can take anywhere from eight weeks to more than 6 months. And every extra week the process takes because of missing documents or multiple sites not being aligned is another week that patients have to wait for groundbreaking treatments. By using technology to make study start-up more efficient, research sites can make life easier for their staff and put their patients first at the same time.
For more about using technology during study start-up, check out our Complete Guide to eRegulatory and eSource. Learn how tech can help sites with start-up and how site-friendly software helps sponsors and CROs too.