The evolution toward decentralized clinical trials has benefitted the pharmaceutical and biotech industries in various ways. Thanks in part to this trend, patient populations are more diverse, studies offer improved patient retention, and data can be collected without in-person visits with wearable devices.
Although these are all positive developments, an increasing number of clinical trials are using multiple trial sites. Unfortunately, without a management strategy, you’re more likely to encounter potentially serious risks. Thankfully, there are several things you can do to prevent headaches and achieve peace of mind.
1) Designate a site coordinator
Managing multiple trial sites requires precise planning and execution. If more than one person is fighting for control, confusion is bound to happen. In other words, you can’t have too many cooks in the kitchen. Select someone to be in charge of communication between each trial site. When issues arise, it’s the site coordinator’s job to decide the next steps.
Remember: your site coordinator doesn’t need to have all the answers. They just need to act as the main point of contact. For example, if there’s a glitch with the trial software, staff can contact your site coordinator. They can then reach out to the information technology team and take the necessary action.
2) Include each trial site in all of your communications
Once you designate a site coordinator, make sure they regularly communicate the same messages to each trial site. If your researchers aren’t on the same page, critical data points and/or observations might fall through the cracks.
There are several ways to keep everyone informed, including:
- Bulk emails. Whenever there’s an update to the trial protocols or data collection practices, send a bulk email to all of your team members at each trial site.
- Virtual meetings. If you don’t think people will read an email, host a virtual meeting with Zoom or Google Meet. Record the gathering and then send everyone a copy after.
- Post a private website or a cloud-based message board. If you manage trial sites in different parts of the world, coordinating time zones isn’t always easy. A private website or electronic forum makes it easy to keep your team informed, even if they’re awake while you’re asleep.
- Send a weekly newsletter that recaps what’s changed during the last 7 days. A weekly recap can be especially beneficial if you regularly need to clarify or modify trial protocols.
3) Invest in site-specific software
Many CROs still use sponsor-controlled portals to gather and interpret data. Sadly, these operating systems are often clunky, difficult to use, and redundant. Why collect and store trial data on your own workstations and then upload it to another program entirely? To avert this common problem, more and more CROs are investing in site-specific software.
Site-specific software refers to a group of programs designed to make planning, tracking, and managing clinical trials easier. These applications streamline workflows, track all necessary data points, and help ensure the quality of your data and data documentation.
4) Conduct regular site inspections
If you’ve got lots to do, in-person site inspections are probably last on your priority list. Still, these routine check-ins are vital. Regular site inspections present an opportunity to review the Trial Master File (TMF), analyze the quality of the data being collected, and ensure you’re in compliance with all applicable regulations.
Pro tip: During each inspection, consider the potential risks that might still arise, such as staff turnover, patient recruitment delays, or changes to the trial protocols. Make time to talk with your team members and ask questions, they’re feedback can alert you to potential areas where you can improve.
5) Partner with a Functional Service Provider (FSP)
Sometimes, the best strategy for managing multiple clinical trial sites is partnering with an FSP. An FSP acts as an extension of your team, by providing part-time or full-time subject matter experts.
At Harbor Clinical, we have a team of incredibly skilled GxP auditors located all over the country. These experts can help you stay in compliance through services such as:
- Vendor/Site qualification
- eTMF/TMF Documentation
- Pharmacovigilance system
By implementing these and other preventive measures at your clinical trial sites, you can stay better organized and manage all the chaos heading your way.
If you’re interested in learning more about the services we offer (and how they can make managing multiple clinical trial sites easier) get in touch today. Please, fill out the comment form below or click here and fill out our online contact form.