According to the American Agency for Healthcare Research and Quality (AHRQ), an EMR system is defined as “an electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one health care organization”(1). An EMR contains the medical and treatment history of the patients in one practice and has significant advantages over paper records. The use of the EMR in clinical research plays an essential role in transforming the operations of clinical trials, mainly in patient safety, quality and efficiency.
EMRs have become a standard tool for clinicians and hospitals over the last ten years, particularly in large healthcare institutions. Nevertheless, many medium or small size institutions still lack access to EMRs. Furthermore, most EMRs in the market today are focused on the traditional workflow of clinical practice. This means that small and medium-size research centers not only have a barrier to access to EMRs, but even if they do have access, these tools are not designed to support the core activities of clinical research.
Understanding the specific needs for EMRs designed to cover clinical and research tasks, Integra IT has created a GCP-compliant EMR allowing the operational integration of the clinical trial participant information. Making unified patient care and diagnosis history easy to access.
Integra IT’s EMR advantages in clinical research (table, graphic)
- Easy to set up by the site according to visits and each study protocol specifications
- Better understand the patient’s health state and record, aggregate, and analyze critical data for clinical research.
- In the Integra IT EMR, data is organized, cleaned, and ready to be analyzed for a specific research question.
- EMR information is accessible to particular roles and secure under strict safety parameters.
- It can be integrated with the Lab samples module, recording results in real-time.
- Mitigate incomplete case documentation with alerts and obligatory fields.
- Integra’s audit-trail feature guarantees transparent information management and traceability.
- EMR filling can be via telehealth, phone call, or chat due to its web-based feature.
- Optimize the resources like staff time and document digitalization.
Point-of-care EMR data can be used to improve clinical trial participants’ experience within the site, and the communication between research team members, facilitating requests and task assignments. The use of the EMR stands as a significant opportunity to better understand the patient’s health state and critical data for clinical research.
Having EMR data ready to be analyzed for a specific research question is of paramount importance for researchers. Hence, specialized clinical research software is an excellent ally for researchers, CROs, and other research-related organizations. EMR allows clinicians and researchers to see a more significant number of patients through better access to their clinical data, helping them spend less time searching for results and reports.
“For us is great to have remote access to patient charts, laboratory result availability, and appointment reminders for our current vaccine clinical trials,” says Felipe Duran, Project Manager from Cevaxin, a research site in Panama, when highlighting some of the Trial 360 benefits.
Integra IT has developed a complete clinical trial management system for sites with a GCP-compliant EMR for clinical research. Additionally, with Integra’s patient-focused mobile applications is possible to record real-time information such as symptoms, alerts, and answers to patients’ doubts. Integra IT tools ensure data safety, accuracy, storage, and privacy protection policies and are safeguarded and supported as specified by the FDA 21 CFR Part 11.
To learn more about Integra IT research site management system and its EMR, Trial 360, as well as complementary systems and mobile solutions of Integra IT, please visit: www.integrait.co