The manual way of patient data input is one of the most resource-intensive, boring, and time-consuming tasks in clinical trials, even though necessary. It often includes the transcription and validation of source data from an EHR system or a pCRF into the eCRF of an EDC system. Well, electronic data capture systems are quite popular among clinical investigators. Considering how clinical researchers spend countless hours transferring clinical data from patients’ EHR systems to electronic data capture systems, it’s essential to leverage EHR EDC integration.
Fortunately, innovations like EHR integration can accelerate and improve clinical trial operations by integrating EDC software with electronic health records. EHR to EDC integration aids clinical investigators in shifting their focus on recruiting patients for clinical trials rather than entering data. Previously, a lot of unstructured patient data from EHR and EMRs remained an untapped resource for clinical research. Only with EHR EDC integration do clinical investigators have easy and direct data access, no workflow disruption, and seamless interoperability.
This article will present some key insights about EHR to EDC integration, enabling contract research organizations and clinical investigators to take note of this beneficial integration.
Why Integrate EHR and EDC?
EHR and EDC need no introduction as to what these systems do. However, it’s essential to understand why its integration is so crucial in today’s connected healthcare ecosystem. Electronic Health Record to Electronic Data Capture integration entails using software to automatically transfer data from the EHR to the EDC system to populate its fields. Further, the combined or aggregated EHR system data is a valuable and easily accessible source of patient health data that is highly useful in clinical research. Simply because this EHR data includes a plethora of information for the clinical research sector regarding population health, illness prevalence, and the use, side effects, and benefits of care treatments/diagnosis, furthermore, through EDC integration software systems, clinical research organizations (CROs), sponsors, and biopharma companies can truly leverage the power of EHR data.
Integration of EHR and EDC is presently at the forefront of the healthcare and life science industry’s thought. A recent Deloitte analysis states, “the Deloitte Center for Health Solutions set out to understand these organizations’ strategic priorities and learned that maintaining and expanding R&D, technological transformation, and global market presence are their immediate focus areas.”
It’s obvious that Covid-19 has accelerated technology adoption and shifted priorities in the life sciences business. However, getting from where we are today to where we want to be in the subject of EHR to EDC integration will need enormous work from everyone in the business. Furthermore, there are concerns about the potential risks involved as well. And one of the primary risks is that several hospitals or healthcare companies don’t fully utilize EHRs. This can pose one of the major EHR-to-EDC challenges in EHR EDC integration.
Well, EDC and EHR integration is a necessity today. And here are two significant reasons-
1. To be the Change in Crisis
There’s no denying that the COVID-19 pandemic imposed a patient-centered obligation on the healthcare community. In other words, day-to-day clinical practice had to continue unaffected. In the event of an emergency, all staff resources had to be dedicated to the patient’s care. Perhaps, the worst affected was the clinical research sector. By imposing lockdowns and operational limits, the crisis only hurt ongoing clinical trials. External trial operators didn’t have access to clinic floors, and patient care jobs were assigned to site staff. Moreover, during the pandemic, the increase in remote patient monitoring and telehealth solutions hindered on-site clinical trial recruitments.
Besides, the data flow chain in clinical trials broke at the point of data input. As a result, numerous investigations went on hold, leading to delays and severe resource loss. Fortunately, cutting-edge clinical trial software such as the EDC system provides an intuitive and dependable approach that reduces the likelihood of such disruptions. And with EHR to EDC integration, the source of data can turn perennial.
2. Switch to ensure Data Streamlining.
Designated professionals handle data sourcing in clinical trials, typically on-site healthcare staff. This consumes too much of their patient’s time and often leads to inaccurate data transcriptions. Perhaps, entering patient data using an EDC form greatly simplifies the process by lowering the time required to enter the information. It can, however, still result in discrepancies. But the simplest solution to eliminate these data entry errors while reliably feeding patient data to the EDC system is to streamline data directly from EHR to EDC forms. Direct data sourcing from EHRs is a difficult task that can only be accomplished by fully integrated clinical trial software solutions or EDC and EHR and EDC integration. In other words, it’s typically possible through interoperability.
The operating software has integrated functions that can easily enable seamless and secure data transfers from EHR to EDC with interoperability. As soon as data signals from diverse healthcare systems are fed into the EHR, semantically interoperable software can tailor to read and interpret them. This data can be bound, simplified, or obtained sequentially using export/import features. Further, within the export and import functionality, the data from the EHR is exported via FHIR. And this includes data models, serialization formats in XML and JSON, and a RESTful API for querying clinical data. The data is subsequently exported and loaded into a clinical trial management system.
Benefits of Integrating EHR and EDC
Now that you can comprehend why EDC and EHR integrated software is critical for clinical trials, we must bring to your notice some key benefits.
1. Streamlined Data Collection
EDC in clinical research can improve the efficiency of collecting research data. But leveraging EHR integration with EDC software can boost the automatic extraction of data from EMRs and EHRs. So, clinical investigators no longer need to manually enter data, and overall data quality improves.
2. Cost and Time Savings
With EHR EDC integration, one benefit is guaranteed: time and cost savings. This integration eliminates data duplication, so clinical researchers are relieved from manual jobs. Moreover, there’s no need for tasks like manual data reconciliation, data cleaning, and so on. And this is a great way to save time and focus more on patient recruitment and the main research.
3. Improved Patient Safety
Lesser errors mean better patient safety, which EHR and EDC integration assures clinical researchers and healthcare providers. Besides, clinical researchers can now directly access detailed patient data within the EDC platform from EHR systems. Further, this integration also allows the monitoring of patient safety measures, adverse events, and drug profiles in real time. Access to reliable patient data aids in early diagnosis and intervention, improving patient safety throughout clinical trials and regular healthcare.
Such an integration promotes interoperability between EDC and EHR systems. And this enables smooth electronic data interchange and collaboration across healthcare stakeholders such as clinicians, researchers, and sponsors. Further, this also improves communication, decreases data silos, and allows for multi-site trials or research investigations.
5. Reporting and Analytics
Researchers and healthcare practitioners can develop real-time reports and analytics from a unified dataset by integrating EDC and EHR platforms. It allows for more rapid insights into patient outcomes, therapeutic efficacy, and safety profiles. These analytics can help with evidence-based decision-making, quality improvement initiatives, and the creation of individualized healthcare strategies.
The world today strives for automated healthcare solutions propelled by integration. Global healthcare catastrophes have demonstrated the importance of these integrations, particularly in clinical trials. It’s safe to say that the transition from manual to direct data sourcing, that’s, EHR EDC integration, is unavoidable. Software solutions are currently creating the digital environment of clinical trials with a clear goal: more accurate data, fewer resources, better workflows, and enhanced patient care.
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Written by Riken Shah linkedin
Riken's work motto is to help healthcare providers use technological advancements to make healthcare easily accessible to all stakeholders, from providers to patients. Under his leadership and guidance, OSP Labs has successfully developed over 600 customized software solutions for 200+ healthcare clients across continents.