Imagine if someone were to give you hours more time in your day. Most people would gladly take it. In essence, that’s what eSource technology offers investigator sites — 30 percent more time to spend on patient care. This is time they would otherwise spend on entering and transcribing data, addressing queries, preparing for Sponsors to conduct source data verification (SDV), and maintaining an audit trail.
By accommodating remote participation in trials, eSource solutions allow sites to better meet the new expectations for patient centricity. Sponsors who can deliver this have an advantage in attracting sites to participate in their trials.
What’s in it for Sites
Integrating Direct Data Capture (DDC) technology, electronic Clinical Outcome Assessments (eCOA), electronic Patient-Reported Outcomes (ePRO), and eConsent into a site’s workflow improves the capture, visibility, and management of data across devices, sensors, telemedicine, and digital health technologies. This proven approach eliminates many needs for heritage Electronic Data Capture (EDC) systems, which can be fraught with delays and data inaccuracies due to paper transactions, transcription errors, and Source Data Verification (SDV) processes.
For Sponsors to take full advantage of a single clinical data platform that supports end-to-end clinical development and clinical data capture, sites must adopt direct capture technology. Even sites hesitant to make this shift can recognize the value in doing so when they understand how it helps them serve their patients. Capturing data directly at the moment of inception helps sites by:
- Saving time. DDC technology allows clinicians to enter data into an electronic record during the patient visit, no matter where it takes place. Other electronic source data such as physician notes, drawings, audiovisual recordings, ECGs, and laboratory results can also be entered directly into the study database as part of the electronic research record. There’s no need to transcribe anything into the EDC, resulting in dramatically fewer queries.
As one site staff worker said, “Once we finish the patient visit, we’re done. There’s no further work. Clinical ink saved at least 30 percent of my time.”
- Improving patient safety. The study team gets a real-time view of all site-based eCOAs and other Case Report Form (CRF) information to support confident decision making and improve patient care. There is no lag time between the patient visit and the ability to monitor the data.
- Supporting protocol adherence. Direct Data Capture technology highlights data fields required by the protocol and/or regulatory guidance to ensure that records are complete. Being able to record data in real time — during the assessment — means that any questions can be addressed while the patient is present, mistakes can be caught before the patient leaves, and adequate documentation is ensured.
- Securing regulatory compliance. eSource technology protects data from its inception, reducing trial risk and making it easy to maintain a digital audit trail. This in turn facilitates success with New Drug Application (NDA) filings.
- Accommodating sites’ workflow needs. Sites don’t have to create their own source documents, and appreciate the way data capture tools simplify complex studies. The ideal solution is designed to mirror the flow of the patient visit, guiding the investigator through the completion of all necessary assessments and ensuring that the documentation required to support scores, and to answer any subsequent queries are captured while the patient is on site.
eSource technology, when delivered in a single clinical data platform, connects data and operations in a way that re-centers clinical trials on the patient for the good of all, including sites.