Trial sites are a cornerstone of clinical research but are often overloaded with a myriad of complex, manual, and time-sensitive tasks. How can sites be expected to create a positive patient experience, ensure safety and efficacy, or provide accurate study data to sponsors if their processes are manual or riddled with inefficiencies?
Decentralized eSource solutions are helping sites simplify complex workflows, reduce redundancies, and maximize their protocol efficiencies so they can focus on what matters most—their patients. We will explore how equipping clinical sites with the right eSource technology can result in positive outcomes for sponsors and CROs.
In the era of digital health trackers and electronic consent forms, it’s hard to imagine that some companies still rely on paper. But they do—lots and lots of paper. One study found that the average 1500-bed hospital prints over 8 million pages per month, totaling about $3.8 million in resources annually.1 Even worse, 76% of healthcare organizations that use an EHR platform admitted to using paper consent forms.1
When sites rely on paper processes, it can result in major disturbances to your trial, including:
Sponsors and CROs should make it a point to completely eradicate paper from their site workflows. eSource solutions unlock the power for paperless data entry and all trial stakeholders will benefit from these decentralized technologies.
Sites are free of the burden of storing and keeping track of cumbersome amounts of paper CRFs. Beyond space efficiency, site staff can achieve eClinical efficiency. EDCs that sync directly with your eSuite of Direct Capture, ePRO/eCOA, RTSM, and telehealth integrations give sites the power to manage end-to-end study operations from a single source of truth. No more waiting on manual entry or length validations thanks to a host of automatic edit checks, skip logics, and missing data alerts.
Calculated variables offer protection against human error on the part of the user, and protocol changes sent down from the sponsor are easy to implement at the site level. These features offer sites a level of efficiency in their data entry and confidence in their data security that is virtually impossible with paper-based data capture.
Whenever a game-changing technology arrives in a heavily regulated industry like clinical research, it should come as no surprise when compliance concerns arise. How can sites and other interested parties be sure that a new eClinical tool is aligned with all of the many facets of the regulatory frameworks that govern clinical research?
Any eSource user with this concern should find it reassuring that the FDA fully backs eSource, and has released guidance for its use in clinical trials.3 In 2020, as a direct response to COVID-19, the FDA released additional guidance surrounding decentralized eSource technology.4
Medrio’s investments in compliance are particularly strong. Medrio’s eSource applications, like all Medrio products, are fully compliant with HIPAA, 21 CFR Part 11, GDPR, and ICH GCP, and more. Our key compliance features such as SSL encryption, single sign-on (SSO), audit trails, and pre-validated environment are all purpose-built to help you maintain a strong security posture so sponsors, CROs, and your sites can have peace of mind.5
eSource was created to alleviate trial burden, not increase it. Yet, due to the growing number of data sources and endpoints collected in a given trial, sites can feel overwhelmed managing what’s expected of them.
eSource that funnels through a unified decentralized trial management suite can help sites sift through the noise by automating redundant processes and strategically supporting in-clinic workflows with virtual ones.
Patient recruitment and enrollment efforts can be aided by eSource workflows such as telehealth screening visits and electronic consent on a web-based portal. Both solutions remove heavy patient burdens surrounding site-based travel and informed consent while allowing sites to manage the entire process from a single dashboard. Offline and remote data entry capabilities ensure sites can maintain visibility and data quality anytime, anywhere. eSource access can be restricted based on user credentials to protect data security and all data transfers to the sponsor are encrypted.
This kind of convenience extends beyond data entry and navigation: eSource also makes it possible for monitors to view data remotely, significantly reducing the necessity of site visits. As such visits typically entail a great deal of preparation on the part of the site, this amounts to a major alleviation of what can be a stressful process.
This was put to practice when Swing Therapeutics leveraged Medrio’s eSource for their first hybrid decentralized study. Their sites were feeling uneasy and underprepared to manage partially virtual workflows and achieve patient compliance in a remote setting. With help from a bring-your-own-device (BYOD) ePRO solution model, in tandem with SMS alerts, and an intuitive interface, the site’s concerns were quickly mitigated. Not only did Swing’s sites report that they preferred telehealth visits over in-person visits, but they also commented on the ease of scheduling and convenience of the eSource system. Swing was able to improve their site relationships by using technology that their patients and sites preferred and the study successfully conducted virtual telehealth visits while achieving 97% patient compliance.6
It’s difficult to dispute that eSource delivers major time and cost savings to clinical trial sponsors. But the right kind of eSource products can be a source of convenience and comfort for site staff as well. It is this understanding – that the technology can be a boon for all parties involved with the clinical research process – that has earned Medrio a position at the forefront of the eSource revolution.