As technological advancements bring the pharmaceutical industry into the future, antiquated methods, such as paper-based record keeping or manual data entry, are slowly being replaced. Similarly, the healthcare industry has seen a significant shift towards digitalization in recent years, making electronic medical records (EMRs) and electronic data capture (EDC) becoming increasingly important tools in medical research. Generally, EMRs are not under the purview of parties like sponsors or contract research organizations (CROs), which answer to regulations set by the United States Food and Drug Administration (FDA); instead, they typically belong to healthcare professionals, organizations, and institutions.
However, their integration with clinical trial EDC systems could present opportunities to improve data accuracy and efficiency in data collection for clinical trial researchers. Interoperable combinations of EMRs and EDC can also reduce cost and time burdens by automatically populating relevant patient medical information into the EDC system. Read on as we discuss the significant impact that EMR-EDC integration can have on the efficiency and effectiveness of clinical trials.
Understanding EMRs and EDC
Electronic Medical Records (EMRs)
EMRs are digital versions of paper-based medical records that have been used traditionally in hospitals and clinics, containing all relevant information pertaining to a patient’s medical history. These systems are designed to be accessible to healthcare providers, clinicians, and patients, and they allow for real-time sharing of medical information between different healthcare providers. The digitalization of patient medical charts has helped provide quick access to patient medical histories, thus reducing medical errors and improving the accuracy of diagnoses and treatment plans.
In clinical research, EMRs can be used to identify potential trial participants, track patient enrolment, and monitor patients’ medical conditions throughout the trial. An individual’s specific medical details can help researchers identify any potentially exclusionary or clinically significant medical condition that may affect their safety or the investigational product’s efficacy. Therefore, the information provided by EMRs ensures that the patients enrolled in the trial are appropriately suited to receive treatment and that the trial is conducted in a safe and ethical manner.
Electronic Data Capture (EDC)
EDC is a computerized system for collecting data during clinical trials; they were originally designed to replace paper-based data collection methods, which can be time-consuming and prone to errors. These systems allow for the collection, verification, and management of electronic data from clinical trials, as well as for capturing data from multiple sources, including EMRs, lab systems, electronic source (eSource), electronic patient-reported outcomes (ePROs), and other electronic medical devices.
Today’s EDC platforms enable automated data collection through the system and allow clinical site staff to reduce the time it takes to enter and analyze data; as a result, they can help improve the accuracy and reliability of data collected during clinical trials. This automation positively impacts the overall timeline of a clinical trial, potentially making new treatments available to patients with fewer delays. The use of EDC also reduces antiquated paper-based methods of data collection and manual data entry to minimize time-consuming inefficiencies within a site, as well as human errors in data entry.
The Importance of EDC Integration with EMRs: Three Key Benefits
1. Improved Data Quality
Because EMRs provide a complete and accurate record of a patient’s medical history, including past diagnoses, medications, and test results, their integration with EDC systems provides a high-quality primary source of data. Most significantly, this information can be used to ensure that patients meet the inclusion criteria for a particular clinical trial and to monitor their progress throughout the trial. By integrating EMRs into EDC, researchers can also reduce the risk of errors that can occur when data is manually entered into a system. Not only would this reduce discrepancies caused by illegible handwriting or misplaced paper notes, clinical research associates (CRAs) and clinical research coordinators (CRCs) would also benefit from the possibility of centralized monitoring. EMR-EDC integration can also provide more seamless source data verification (SDV) for key pieces of eligibility information within a participant’s study file.
2. Increased Efficiency
EMRs are digital platforms which receive information across an entire network of healthcare providers that each patient may see in their lifetime. This allows healthcare professionals to access patient information quickly and easily, which can reduce the time it takes to screen patients for a clinical trial. Furthermore, integrating EMRs into EDC can also help to streamline the process of patient recruitment. Many health record systems often allow its users to conduct targeted data mining tailored with specific filters, such as medical history, demographics, and current medication use. Site staff can use these capabilities to automatically identify potential candidates based on these filters with greater speed and efficiency. Patient recruitment is a time-consuming process as is, but the possibilities opened up by EMR-EDC integration would help conserve valuable time and resources from the sponsor’s, CRO’s, and site’s team of research professionals.
3. Enhanced Patient Safety
The nature of EMRs ensures principal investigators and researchers have access to the most comprehensive view of a patient’s medical chart, which can help identify potential safety concerns before a patient is enrolled in a clinical trial. EDC systems can also be designed to alert researchers to potential adverse events, allowing them to act quickly to protect patient safety. By integrating EMRs into EDC, researchers can also more easily track adverse events and monitor safety throughout the trial, including events related to treatment non-compliance or misunderstandings with dosing instructions.
The Vial EDC Platform
The benefits provided by EMR integration into EDC systems are well-known, but they also require extensive expertise to bring into existence. Vial is a next-generation, tech-first CRO reimagining clinical trials to deliver faster, more efficient trial results at dramatically lower costs for biotech and biopharma sponsors. Our team recognizes how integration of EMRs with EDC systems can be game-changing for improving the clinical trial experience.
We are one of the few CROs to offer a modern, intuitive EDC platform developed fully in-house by Vial’s expert team of software engineers. Vial EDC provides essential features, including a consumer-friendly UI/UX design, simplified real-time eCRF (case report form) data input, and streamlined remote monitoring capabilities. More importantly, this EDC is the heart of Vial’s suite of eClinical software products, such as ePRO, eSource, and our latest Onboarding app. The easy crosstalk built into each of these platforms allows clinical research sites to cut down on time-consuming and redundant repetition of data entry because it automatically populates the EDC as information comes in. Learn more here about how Vial’s innovative EDC system compares with that of other industry leaders.
Technology-Forward CRO
CROs like Vial are leveraging their extensive digital expertise to help sponsors and healthcare organizations invest more in these technologies, as well as achieve integration between EDC systems and quality patient health data sources, such as the EMR. Visit our website or contact a team member today to discover how we can help with your next clinical trial!
