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Using EHR and EMR data for research fundamentally differs from capturing research data prospectively, as it’s customary in controlled clinical trials. Several aspects of EHR systems contribute to these significant discrepancies. And the most notable of which is the lack of investigator control over data collection and recording processes in healthcare facilities. Other issues include a need for universal definitions for identifying patient cohorts and study-specific outcomes. So, these are challenges with longitudinal data completeness and potential mistakes in record linking across systems. And all of these problems put investigators under pressure to ensure and demonstrate that data are of sufficient quality to support research results. In short, using EHR and EMR systems in clinical trial software is indeed the need of the hour.
Developing a link between EMR software solutions and clinical trial software has long been regarded as the next step in data gathering and processing. And this follows the development of electronic data capture (EDC) technologies that replace paper. Moreover, integrating the EMR and EDC would also allow for more accurate and efficient clinical trial data gathering, especially in multi-site trials. To help better understand the necessity of integrating EMR systems and clinical trial software, this article will offer some profound insights into this.
What is a Clinical Trial Management System and Its Components?
A clinical trial is an experiment that is carried out to ensure the safety and efficacy of novel medicines. A pharmaceutical, biotechnology, or medical device business funds the clinical trial for its medication or product to be licensed by the FDA or another international regulatory body. They frequently hire a contract research organization (CRO) to organize and conduct the study. It is normally completed in four steps. It begins with lab testing and progresses to human testing. The dosage is modified, and participants are raised at each step.
Besides, the primary objectives of clinical trials are-
- To capture patient data and study design
- To collect patient outcomes
- To ensure centralized trial management
- To ensure supply management
Based on these objectives, the clinical trials software has these components – EDC, ePRO, RTMS, and CTMS. And these define the clinical trial workflow. Here’s how it works:
1. Capture patient data and study design using EDC
The most common documents used during trial design are protocol and case report forms or CRFs.To define a protocol, one can term it as a compilation of objectives, methodology, evaluation criteria, and, at times, locations. On the other hand, CRFs are just simple questionnaires to store the data related to research participants. Today, most clinical trial companies use eCRFs which EDC creates.
Electronic data capture, or EDC, is a program used to record and collect clinical documents. EDCs provide CDISC-compliant templates that make designing and exporting eCRFs simple. Besides, EDCs can be as complicated or basic as the research team wants them to be. In reality, an EDC comprises a graphical user interface, a query management module, and a reporting tool. Moreover, EDC has replaced the previously used Clinical Data Management Systems (CDMS) in clinical trials. Clinical Data Management is the technique of producing the highest quality data with the fewest errors. So, EDC is a CDMS, and the words are often used interchangeably.
Clinical studies use EDCs to collect CRFs, but integrated solutions can go further. EDCs and EHR integration can automatically receive data from applications and medical devices at hospitals and ePRO questionnaires with the correct connectors.
2. Collect patient outcomes using ePRO
While CRFs are EDC’s main data source, the clinical trial’s remaining data is from ePRO or clinical outcome assessment (eCOA). Electronic Patient-Reported Outcomes, or ePROs, are patient-facing clinical research software tools that allow participants involved in the study to monitor and report their health. Besides, they are quite similar to questionnaires or surveys. And these can be accessible via clinical trial software companies’ sponsored pre-installed application, which is available on a tablet or smartphone. ePROs are frequently custom-built with top vendors, such as ERT, CRF Health, Parexel, Medidata, etc. There are other third-party vendors too.
Besides, ePRO data can only be used for FDA approval if it complies with regulatory applications. As a result, the majority of ePRO surveys are performed on-site. That means that the greatest obstacle can also be the greatest opportunity. And that developing a compliant ePRO solution, which can be utilized on a patient’s device, will accelerate integration and lower trial expenses.
3. Ensure supply management using RTMS
Any authentic clinical study is frequently conducted in a hospital setting with nurses and doctors as coordinators and investigators. They employ various processes to run experiments efficiently and without any prejudices. And generally, Interactive Response Technology (IRT) is often used to manage the randomization of subjects of clinical trials and drug supply management for clinical trials. Acronyms like RTSM (Randomization and Trial Supply Management), Interactive Voice Response Systems (IVRS), and Interactive Web Response Systems are also used for IRT.
All of these essentially refer to the same type of software used to randomize trial participants, those who received a placebo vs. those who received the genuine drug and delivered the set medicines. Tools like these use configurable algorithms, including Natural Language Processing and Machine Learning technologies, to comprehend your trial requirements and reduce drug waste. And the vocabulary will be determined completely by the vendor. Take, for example, Medidata Rave RTSM, Medpace ClinTrak IRT, or ITclinical IRT: IWRS. Above all, RTMS in clinical research software is an important component ensuring the key task of dispensing medicine to a select group of participants.
4. Ensure centralized trial management using CTMS
The Clinical Trial Management System, CTMS, is a software used to organize and streamline the clinical research workflow. It is typically utilized by a research sponsor (a pharmaceutical, biotech, or medical device business) or a Contract Research Organization (CRO) company, which a sponsor hires to manage the study.
That means CTMS is typically a project management solution that oversees multiple functionalities. CTMS clinical trial management system can easily track the trial’s progress and create milestones, check how each team is performing, plan visits of participants, manage connections between team members, regulate costs, and prepare reports. In short, this software takes care of everything involved in clinical research.
These components in the clinical trial software have to carry out specific functions. Perhaps, it’s smart to integrate the EMR system with these robust clinical trial management software solutions. Achieving uniformity and efficiency in clinical research is crucial in today’s complicated healthcare system. And even if it takes scrapping the existing solutions to develop an integrated system, be it that. But it’s just EMR development, and integration with CTMS solutions or clinical research software isn’t enough. It’s also essential for the clinical research team and trial sponsors to embrace the integrated clinical trial data management software. Doing so will only boost clinical trial efficiency, streamline workflows and ensure interoperability.
Why is Integrating EMR with Clinical Trial Software Important?
There is a significant difference between how data is maintained in healthcare and clinical trials. Solutions such as healthcare analytics, EMR, or medical informatics manage sensitive data in a regular healthcare setting. But in clinical trials, electronic data capture systems, CTMS solutions, and RTMS software are mostly used. In other words, almost all data are more likely to be stored digitally with robust solutions like EMRs, EHRs, and EDCs. Perhaps, the only issue that comes in is the difficulty for both parties in clinical trials (trial team and participants) to access the data. Further, in such a case, the trial becomes unproductive given that EDC data is initially recorded and will be used in healthcare. And EMR and EHR systems preserve data records for research, but the connectivity between EMR or EHR and EDC or clinical trial software does not exist.
Clinical trial management systems (CTMS) and electronic medical record (EMR) systems are two distinct software solutions for different healthcare purposes. Both are beneficial individually since both systems are tailored to the specific requirements of the institutions that adopt them. While CTMS is solely for clinical trials, EMR software development primarily focuses on effectively storing clinical and patient data. Whether it’s remote patient monitoring, CTMS, or practice management solutions, integrating EMR and EHR will only prove an advantage.
In the case of a CTMS in clinical research, user institutions can benefit greatly from specific functionality that allows them to handle operational data for all their clinical trials. Further, it ensures compliance with numerous regulatory and internal reporting requirements and records clinical data for research subjects. And as mentioned previously, EMR systems are designed to manage information about individual patient’s healthcare requirements. The integration will surely make the task of clinical trial software companies a lot easier.
Besides, interoperability is a major challenge in clinical trials. And the risks involved due to lack of interoperability need no explanations. Meanwhile, FDA also encourages clinical researchers to use EMR-integrated software for clinical trials so they don’t have to enter data manually. However, even with integrated systems, the interoperability challenges continue. Complex and diverse data standards can be a roadblock. So, FDA encourages structured data exchange between EMR and clinical trial platforms. This means the data entered at point-of-care, if structured, can be used multiple times without any manual entry.
Several healthcare experts and companies have long advocated integrating EMR and EHRs with hospital systems to gather patient demographics and laboratory data for clinical trial patients. Of course, this integration guarantees to eliminate the need for clinical research staff to re-enter this data into clinical trial management systems, reducing data transcription errors. However, information can also flow from a CTMS to an EMR to aid in patient safety and billing. When healthcare providers can use the EMR to identify that their patient is enrolled in a clinical trial, patient safety can be improved. Similarly, obtaining the most recent billing grid information from the clinical trial management system to inform patient billing aids them in ensuring Medicare/Medicaid billing compliance.
Recognizing the importance of clinical trial enrollment information and the billing grid for each clinical trial, several clinical trial companies or contract research organizations collaborate with Epic EMR solutions to integrate clinical trial enrollment information and the billing grid for each clinical trial. Such a partnership can establish the framework for EMR integration between the CTMS in clinical trials and EMR software systems. In short, the importance of system integration has never been greater. Technology exists, but all parties must prioritize it to propel it forward. It is critical to the future of patient care and clinical research.
Top Reasons Why Integration of EMR and EDC in Clinical Trial Software Makes Sense
Now that you understand why integrating EMR systems and clinical trial software is essential, especially today, you’ll agree that integrating EMR and electronic data capture software will make more sense. In the clinical trial management system market, CTMS, electronic data capture systems, and RTMS software are crucial (as mentioned previously). However, connecting EDC and EMR systems will benefit clinical investigators more. And here are some of the top reasons-
1. Offers Value Proposition
Integrating EMR and EDC systems for clinical trials delivers a substantial value proposition to healthcare stakeholders such as patients, providers, and clinical research companies (CROs). Patients, for example, can benefit from increased access to their medical records, which can alleviate the strain of filling out numerous paperwork for clinical trials. On the other hand, healthcare practitioners can profit from improved patient outcomes, fewer data entry errors, and more efficient workflows if EMR is integrated. And above all, CROs can also use the integration to improve their operations and acquire insights into the efficacy and safety of the investigational product. In short, EMR connected with EDC will ensure a smooth flow of information, maintaining data accuracy.
2. Regulatory Changes
The value of combining EMR and EDC systems has been recognized by regulatory authorities such as the US Food and Drug Administration (FDA). They have issued guidance sheets and launched activities to promote such integrations in clinical trials. The FDA, for example, has a “Real-World Evidence Program” that supports the use of data from electronic health records (EHRs) and other sources to assist regulatory decision-making. Besides that, in 2013 FDA’s Guidance on Electronic Source Data in clinical investigations and the 2016 Draft Guidance based on data from EHRs for clinical investigations are some notable moves. Even regulatory authorities expect this integration to be a paradigm shift in the clinical trial industry.
3. Multiple uses of data
Since integrating EMR and EDC clinical trials can result in a plethora of data, it’s obvious that data can be used for various purposes. Data captured from the EDC systems during clinical trials can support regulatory filings, uncover safety concerns, and obtain insights into patient outcomes. Further, the data can also be used for post-marketing monitoring, real-world evidence studies, and health economic assessments. Of course, the uses of this data from EDC software will be diverse owing to the large amounts of data generated.
4. Evolving technology
If we look back a decade ago, healthcare and life science technologies were limited. Soon with EHR development and electronic data interchange, the healthcare sector started to adopt the technology. As the healthcare business rapidly evolves, new technologies like cloud computing, clinical data analytics, and more are being introduced. On that note, EMR integration with EDC Software can help stay up with this evolving technological landscape, making it easier to include new technologies in clinical trials, such as wearables, mobile health apps, and telemedicine.
5. Evolving data standards
As the volume and complexity of clinical trial data increase, standardized data formats and interoperable technologies are required. So, EMR and EDC integration is a must. This integration can assist in meeting these requirements by allowing data to be generated and stored in standardized formats. Moreover, the integration will also ensure that this standardized data captured from EDC is easily transferred between systems, ensuring interoperability in clinical trial software.
6. Emphasis on patient centricity
In clinical trials, there is an increasing emphasis on patient-centricity. Clinical trial experts and investigators are focused on enhancing patient experience and outcomes to make healthcare and clinical research more patient-centric. By decreasing the load on patients, enabling remote monitoring, and facilitating data interchange between patients and healthcare professionals, the integration of EMR and EDC seems the best route to achieve it.
7. Confluence of Healthcare and Life Science
The healthcare and life science industries are currently merging in multiple ways. With the primary focus on personalized medicine and precision health, life science and healthcare stakeholders collaborate on the same vision of patient-centric and value-based care. That’s possible by enabling the seamless data interchange between healthcare and life science systems. In other words, integrating EMR and EDC can help facilitate this convergence.
8. Offer the commercial opportunity to clinical trial companies
Finally, integrating EMR and EDC can provide clinical trial companies diverse economic opportunities. Take, for example, it can assist them in minimizing the duration and expense of clinical studies, increasing data quality, and boosting the company’s competitiveness. Furthermore, it can help improve patient recruitment and retention, which can be difficult in clinical trials. In short, integration enables clinical research organizations to save overhead expenses and increase revenue.
These reasons clarify how EMR integration in clinical trials EDC systems proves beneficial, especially if the contract research organizations, sponsors, or investigators are trying to get an edge over others. Besides, healthcare organizations collaborating with clinical trial companies also encourage integration to make the process more optimized and less time-consuming.
How Can Connect EMR with Clinical Trial Software Bring Real-World Data to the ForeFront?
The potential to improve clinical research using electronic medical records has been known for over two decades, but progress must be faster. However, experts agree that with the right tools and strategies, EMR integration can improve patient outcomes and accelerate the development of new treatments. This can be achieved through clinical trial software, medical research software, clinical trial management software, and other CTMS software solutions. EHR/EMR integration in clinical trials provides many benefits, including streamlined processes and efficient data collection. By performing and analyzing automated data, the EMR can help speed up the development of new treatment methods and therapy and thus improve patient results. Before integrating into EHR clinical trials, there are some challenges to solve.
One of the main problems is data fragmentation. EMR data is often stored in different formats and locations, making it difficult to collect and analyze. This problem can be solved using a clinical trial management system (CTMS), simplifying data collection and management. CTMS solutions can help ensure that data is collected efficiently and appropriately analyzed to meet the needs of clinical trial systems. Another challenge is privacy concerns. The patient’s health data is sensitive, and it is important to protect them properly. To address this, the industry needs to adopt a collaborative approach to data sharing and work to develop standardized data formats. This helps ensure that patient data is properly protected and used to benefit both patients and researchers. Finally, there needs to be more standardization. EMR data is often stored in different formats and locations, making it difficult to collect and analyze. The industry must work hard to develop standardized data formats across different platforms. This helps ensure that data is collected, analyzed, and shared correctly and used to benefit both patients and researchers.
Beyond Technology Solutions
Real-world data (RWD) from electronic medical records (EMRs) can improve the efficiency of clinical trials and enhance patient outcomes. However, integrating EMRs into clinical research is more than a technological challenge; other factors are involved. The industry needs to change its approach to study recruitment to make this innovation successful. Traditional recruitment methods, where each site recruits patients independently, can result in a lengthy and inefficient process, often leading to study initiation or discontinuation delays.
Access to large-scale EHR data can streamline the process by allowing researchers to quickly identify patients with the right inclusion criteria and enroll them all at once. However, there are barriers to this approach, including the recent “data land grab,” where no single vendor or organization has access to all the necessary patients for a clinical trial. This is particularly true for rare diseases or personalized medicines; partnerships are needed to find the necessary scale.
According to some healthcare experts, integrating EHRs and EMRs into clinical research requires an integrated clinical care program where researchers can learn and evolve to understand the best outcomes for patients, clinicians, clinical workflows, and communities. There are many advantages of EHR when conducting clinical research, such as eliminating manual data extraction from charts and making research data collection a by-product of routine clinical record keeping.
The industry needs to address study recruitment and other challenges to make this innovation stick. Clinical trial management software, or cms solutions, can help streamline the process by providing real-time data access and analytics, facilitating collaboration, and automating tasks. Ultimately, the successful integration of EHR into clinical research requires the alignment of data from different sources, closing the feedback loop between science, evidence, and care, and supporting clinical trial systems to implement EHR in their operations effectively.
Capturing potential participant data is just one part of the puzzle in clinical trials. To successfully enroll participants, there must be a bridge between the data and humans. This means providing the necessary infrastructure and tools for healthcare systems and clinical trial systems to participate in research. Clinical trial software, such as clinical trial management software, can help sites manage clinical trials’ administrative and regulatory aspects.
However, many healthcare systems may need more resources or training to handle clinical trials, hindering participation. This includes concerns around regulatory filings and submissions, the need for familiarity with the research environment, and the need to demonstrate a steady stream of clinical trial work to justify the investment.
To address these challenges, collaborative projects like the Cerner Learning Health Network provide support and infrastructure for willing healthcare systems and clinical trial systems to participate in research. This nationwide network of provider organizations offers access to their data and is willing to accept clinical trials, quality improvement, and outcomes research opportunities. By providing access to clinical trial software and other CTMS solutions, the network minimizes the administrative burden and accelerates participation, even for organizations without a history of research involvement.
Ultimately, the goal is to ensure that clinical trial software has everything they need to use the data they hold, from the right software and tools to a principal investigator. This can promote greater participation in clinical research, leading to improved patient outcomes and advancements in medical knowledge.
Feedback Loop Closure
According to Stankus, the healthcare industry needs to do more than use real-world data (RWD) from electronic health records (EHRs) to improve patient outcomes. Instead, they need to ensure that routine care insights can be used to guide future research. This requires an integrated clinical care program that evolves to understand the best thing for patients, clinicians, clinical workflows, and communities.
However, there are some barriers to implementing this approach, such as more data quality and completeness in some EHR systems. Clinical research software, including clinical trial management software (CTMS) solutions, can help overcome these barriers by standardizing data fields and codes. These solutions are designed to understand specific data and have standardized data dictionaries across sites, ensuring all the information needed for outcomes is collected.
EHRs were originally designed for billing purposes and have unstructured formats and varying data coding between health systems, making extracting useful information challenging. As suggested by the FDA, greater standardization of data fields and codes could help shift this dial, ensuring that insights from EHRs are not wasted.
Many data that aren’t captured in EHR systems could enhance their value, such as understanding certain symptoms, severity, or the worsening of control in certain situations. Patient-reported outcomes are where EHRs can build capacity and understanding of how people experience their health conditions, not just as a patient but as a whole person. Clinical research software, including CTMS systems, can help collect this data and provide a more comprehensive picture of patient outcomes.
The healthcare industry is currently at a tipping point when utilizing RWD to improve patient outcomes with the help of appropriate technology and a positive mindset. However, the key to success lies not just in technology but also in collaborating to create and provide access to suitable datasets and ensuring that the right tools are available to those who require them. This would include clinical trial software, clinical research software, medical research software, and other tools such as clinical trial management software (CTMS) systems and solutions, which can aid in data collection, management, and analysis. By working together and sharing resources, the industry can make the most of RWD to advance medical research and ultimately improve patient outcomes.
Benefits of Integrating CTMS and EMR
Integrating clinical trial software and clinical trial management software with electronic medical record systems can benefit patient care. Clinical trial software, also known as a CTMS system, is designed to manage clinical trials, while electronic medical record systems, or EMRs, store patient health information. By integrating these two systems, healthcare providers can access accurate and up-to-date patient information, significantly increasing patient safety and improving overall communication between healthcare providers. A significant benefit of integrating CTMS and EMR systems is that it increases efficiency and reduces errors during clinical trial management.
Healthcare providers often have to manually enter information into separate systems, which can be time-consuming and lead to transcription errors. By automatically transferring information between systems, staff can spend less time manually entering information and focus more on patient care. In addition, integrated systems can simplify clinical trial management and improve collaboration between clinical trial sites. CTMS systems can send information to the EMR, such as payment terms, which can reduce errors in clinical trial billing and the risk of organizational non-compliance. In addition, clinical trial management software can help ensure efficient data collection, management, and analysis, leading to better collaboration between clinical trial sites and faster development of new treatments.
1. Safety First
Integrating clinical trial management software (CTMS) with electronic medical record (EMR) systems can significantly benefit patients participating in clinical trials. One benefit is improved patient safety. In the case of acute health problems, the attending physician needs to know whether the patient is participating in a clinical trial. Through CTMS and EMR integration, the CTMS system can send important information to the EMR and identify the patient as a clinical trial participant. This allows doctors to make informed decisions about patient treatment and avoid unwanted drug interaction effects, ultimately ensuring patient safety during treatment.
Additionally, integrating CTMS and EMR systems can improve data accuracy, ensure billing compliance, and increase operational efficiency. Transcription errors may occur when the data is manually entered into a separate system, causing compliance problems. Employees can avoid manual data entry time by using information communication between automation systems, leading to more accurate and consistent data. This simplifies staff workflow, thereby increasing the efficiency of clinical trial management and ultimately improving patient outcomes.
2. Compliant Billing
Integrating a clinical trial management system (CTMS) and an electronic medical record (EMR) can greatly improve billing compliance in clinical research. When using separate systems, manual data entry can lead to difficulties in communicating and routing charges correctly, which can result in billing errors and compliance issues. By integrating CTMS and EMR systems, charge determinations are automatically communicated between the two systems, decreasing the likelihood of errors and potential non-compliance. This streamlined process can also increase operational efficiency and accuracy, saving time and resources for research organizations.
3. Accurate Data and Efficient Operations
Utilizing separate systems can lead to staff members having to enter the same information twice, which is both time-consuming and can increase the risk of transcription errors. By integrating a clinical trial management system (CTMS) with an electronic medical record (EMR), data communication is automated, decreasing the amount of manual entry required by staff. This increases data accuracy and consistency while also streamlining staff workflows.
Clinical trial software, such as CTMS solutions, is essential for effectively managing clinical research studies. However, with integration with an EMR system, opportunities for effective communication of patient information can be noticed. For example, suppose a patient enrolled in a clinical trial visits a hospital for an emergency health issue. In that case, the attending physician must be informed of the patient’s participation in the clinical trial. This can be achieved by integrating a CTMS and an EMR, which can communicate information and flag the patient as a clinical research participant within the EMR.
Billing compliance is another critical aspect of clinical research management. When separate systems are utilized for clinical research billing, there can be difficulties in communicating and routing charges correctly, which can lead to billing compliance issues. Integration of a CTMS and EMR automates information communication, including charge determinations, from the CTMS to the EMR. This reduces the risk of noncompliance for organizations conducting clinical research studies.
CTMS and EMR integration benefits patients and staff and the quality of health care overall. By automating communication and data entry, staff members can spend more time on patient care and less on manual data entry. This ensures the accuracy and consistency of data, resulting in better patient outcomes.
With insights from this article, you can truly comprehend how EMR and EHR integrations can change the outlook of healthcare and clinical research studies. Of course, there’s no debate that electronic health records and electronic medical records systems have redefined the medical storage and electronic data exchange scenario. However, the paradigm shift arrived late in the life science sector. Today clinical trials are not just a conventional survey but a lot more than that. And with CTMS and EDC solutions, investigators can bring some real developments in patient outcomes and in, controlling costs and optimizing care delivery. And in such complex workflows within clinical trials, integrating EMRs can only make processes smoother and more optimized.
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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.