5 Ways to Support Clinical Research Sites: Meeting Data Collection Needs & Maintaining Financial Stability

Clinical research sites are critical stakeholders in the clinical trial data collection process. Sites are the primary sources for much of the data collected from patients and entered into electronic data capture (EDC) systems. Yet, their perspectives are often overlooked when evaluating the processes surrounding data collection and entry.

What are some of the main challenges that clinical research sites face when collecting and entering data? And how do these data collection issues impact the financial stability of sites? Read on to discover how sponsors and CROs can better equip and support sites in a timely manner through innovative technology solutions to keep clinical research on track.

1) Better Clinical Trial Site Support and Training

Many data collection complications arise from system-related issues. Among the most common culprits are erroneous auto-queries, which stem from system errors, incorrect date/time formats, and session time-outs during clinical trial data entry that result in the loss of unsaved data.

Additionally, system and protocol updates are not often implemented in a timely fashion, which forces teams to go back and re-enter data for past visits. Many system-related errors require IT support to resolve. And without timely support, site teams lose valuable days of progress, delayed payment and time with patients.

One of the best ways to support clinical research sites is to offer timely IT support when issues arise to fix problems quickly. Additionally, sites need access to user training that proves value not just for current studies, but also for future ones. This will help with the high turnover rates at sites and allow for a new site coordinator to come in with the support they need. 

2) Single Sign-on and Unified Clinical Trial Solutions

Among the biggest complaints from sites is the lack of integration or interoperability between clinical trial solutions. Often, sponsors use different vendors and software systems—many of which do not work together effectively. Site personnel find themselves hopping from one system to another, using different logins across multiple vendors and losing valuable time in the process. Worse, a lack of interoperability may require manual data entry, which dilutes efficiency and increases the likelihood of errors. Instead of multiple systems, logins, and passwords, consider a unified platform with a single sign-on across multiple applications to simplify the process for clinical research sites.

3) Efficient Timelines for eCRF Guidelines

Electronic case report forms (eCRF) guidelines are critical for sites’ source documentation and data collection practices, which are built around such guidelines. Too often, sites receive eCRF guidelines right before the study starts, making it difficult to see how the build matches the data collection methods. Getting eCRF guidelines earlier solves many of the initial problems that sites face and reduces the need for queries that stem from the build-out and can reflect poorly on sites. It also alleviates the downstream effects of delayed data review which leads to delayed site payments. Keeping your sites financially stable is important, especially in these times of inflation.

4) Involve Clinical Research Sites in Trial Build-outs

Consider going a step further with your EDC build-outs and involve sites earlier in the process. Site personnel are the ones who enter data and navigate the challenges that arise. However, they are rarely asked for their feedback on the build-out. Doing so benefits all parties involved—the EDC vendors (issues are caught early), the site (more time saved and fewer issues to work through), and ultimately, the study itself (fewer queries and cleaner data entry).

There is also the consideration of the mapping of the EDC build and the investigator budget build. If there is a clear connection for sites around what clinical trial data entry equals payment, it will keep sites more engaged and allow for better cash flow at the sites.

5) End of Study Assistance

The End of Study (EOS) Media process is complex and time-consuming for sponsors and sites alike. Traditional approaches to EOS take up to 15 steps to complete and involve physical CDs and paper-based acknowledgement forms. These physical copies are easy to lose track of over time, and accessing data from these formats is tedious. Rave Site Cloud: End of Study (EOS) has reduced the EOS process to just 3-4 steps.

Rave Site Cloud: End of Study is the first end-to-end solution that generates, distributes, and manages study files at the end of the study. Site Cloud EOS lets sites complete the EOS process seamlessly through a secure, stable, and unified platform. All end of study documents are sent electronically to the sponsor and securely stored to take the burden off sites at the conclusion of the study.

And let’s not forget the financial factors within the end-of-study reconciliation process. Sites need a clear way to reconcile site payments at the end of the study; Rave Site Payments allows for this with on-demand reporting within their site portal, which is also part of their single sign-on. Giving sites complete visibility to their clinical trial data entry and site payments on one platform will equip them with the tools to operate their sites efficiently and set them up for success for the next study.

Summary

Clinical research sites face many data collection challenges during clinical trials. These challenges have several downstream effects on recruitment and the financial stability of sites. Many of these hurdles are avoidable if the proper solutions and support are in place. More attention paid to eCRF guidelines, timely IT support, and single sign-on capabilities as part of a unified platform are just some ways to support sites with data collection and entry. Doing so allows sites to perform at their best and get data back to sponsors and CROs in a timely manner to conduct the necessary research and, ultimately, get live-saving therapies to market faster.