3 Must-Haves to Deploy Remote Clinical Trials

Decentralized clinical trials (DCTs) are becoming one of the most dynamic ways to conduct clinical research. The ability for research sites to deploy remote trials elevates opportunities easily and effectively, priming them for increased sponsor awards and participant engagement. In order to capitalize on all the benefits DCTs have to offer, clinical research sites must embrace the myriad of technologies making remote trials possible. This blog covers three must-have decentralized trial tools to efficiently and compliantly implement remote modalities at your organization.

Remote Workflow Capability

A main concern regarding successful remote trial work is preserving source document workflows, critical approval processes, and CRF completion. If a research site doesn’t have processes or technology in place to address these concerns, sponsors may not select them for remote research. Even if a site transitioned to mostly remote workflows, leveraging tools like a clinical trial management system (CTMS) or an eRegulatory management system demonstrates a site’s ability to effectively and compliantly manage remote workflows. However, the process of transitioning to remote data capture and case report form (CRF) completion is challenging. In order to keep the process moving and provide timely access to avoid unnecessary delays to remote principal investigators (PIs) and monitors, sites need an effective eSource system. eSource not only captures screening and visit data effectively, but also empowers team members, reviewers, and approvers working remotely to leverage 21 CFR part 11 compliant eCRF workflows instantaneously.

Electronic Consent Management

Maintaining updated hard copy consent documents are complicated for site-centric clinical research models, but they are especially impractical for remote trial work. Electronic consent, also known as eConsent, systems digitize the process of facilitating and obtaining initial and ongoing informed consent. While this is a necessity for all trials, it’s especially critical when participants never physically enter a site. Entering consent forms directly into the system increases information accuracy and completeness, helping boost sponsor satisfaction and ensure audit preparedness. Due to its dynamic digital nature, eConsent systems provide diverse engagement tactics via images, audio, video, and other eLearning elements to ensure informed consent and increase participant comprehension. Digitizing the process of obtaining consent can increase the chances of a positive participant experience and boost retention.

Video

Remote trials help remove a significant barrier to participating in research: frequent travel to a brick and mortar research site. However, requiring fewer in-person visits opens the door for improved research access and new participant engagement tactics. In order to maximize the remote participant experience, decentralized trials require technology to facilitate virtual visits, designed with both sites and participants in mind. Secure video conferencing is a critical component for remote trial model success, as it allows sites to complete study visits virtually, increases site revenue, and reduces in-person monitoring costs. Convenient video solutions don’t require special app downloads or installation, making it easy for participants and clinicians to gain access. They should also support multiple attendees to join, in case participants have home health care or family members who are involved in their trial participation. In addition, integrated video capabilities with your Clinical Trial Management System (CTMS) or EHR system further centralizes your workflows and eliminates multi-system visit data entry.

Explore more resources about how these tools can help your site succeed in the new remote research landscape:

• Blog: Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
• Blog: How to Be Research Ready Today and Beyond
• eConsent: reduce audit findings and improve consent process
• eSource: collect high quality source data

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