Introduction

Data management is one of the main priorities of research teams and medical institutions. Due to the abundance of information in clinical trials, experts require good data capture, integration, storage, documentation, and transfer of material (Zhang et al., 2017).

During clinical trials, research data can be captured and documented electronically or in paper forms. As data collected via pen-and-paper techniques need to be transferred to enable further analysis, data might be prone to errors, low levels of readability, and limited usage. Electronic data capture (EDC), on the other hand, is a computerized system of collecting clinical data for use in human clinical trials in an electronic form. In the recent years, EDC systems have become a leading tool in research.

Electronic Data Capture: Research & Digital Future

EDC solutions are suited to meet the needs of life science organizations, including medical, pharmaceutical, and biotechnology industries. EDC systems can be used in different phases of clinical trials to collect, report, and manage lab results and a wide variety of clinical data. They not only streamline the collection of medical information but also expedite the time taken to market medical devices and drugs. As such, EDC can literally save lives (Price & Wilson).

The capabilities of EDC systems vary from the basic stand-alone databases, which are used to enter data in a single-site trial, to the more complicated systems, which can facilitate multisite clinical trials. Perhaps one of the most advanced features of EDC is that they enable remote and real-time entry, validation, tracking, reporting, and randomization of clinical data over the web.

Not surprisingly, EDC solutions have replaced the traditional paper-based data collection methodology. Unlike paper-based data collection, EDC programs allow quick entries, cleaning, and analysis. The sophisticated EDC programs help experts access data in real time, 24/7 – with patients’ confidentiality and well-being being a focus of research.

EDC in Clinical Trials: Benefits

Join the Future: One of the main reason to implement EDC in research is the leading trends of digitalization. Today’s society has implemented technology in all aspects of life, and research is not an exception. In fact, medicine is the main industry that should benefit from technology as it deals with patients. Thus, EDC can help you look to the future of science and medicine.

Boost Your Productivity: EDC helps researchers resolve all the productivity and efficiency issues, which might be entailed in clinical trials. As paper forms might be too time-consuming, transfer of data – incorrect, and changes – delayed, EDC can facilitate and enrich research. Note that good EDC systems do not interfere with drug administration, workflow, and monitoring.

Cut Costs & Time: EDC leads to an overall reduction in the costs and time involved in the trials. In general, EDC is more cost-effective in the long term and leads to quick results. For instance, as EDC gives access to data in real time, changes can be done simultaneously, eliminating errors and delays.

Enjoy Research: With EDC technology solutions that enable point-and-click, and drag-and-drop design modules, much of the set-up and study design programming burdens have been taken care of. Thus, levels of satisfaction among patients and experts increase. In addition, easy-to-use interface can enhance engagement.

Electronic Case Report Forms: Benefits

Faster access to data. With effective EDC systems, real-time access to data is not a myth. In addition, EDC supports faster decision-making and enables tailor-made trial designs. There’s also a faster access to data for analysis, with less time spent on query management. All these features and opportunities promote the study progression and further audits.

Data accuracy. With the implementation of EDC, it is much easier to enforce certain features of data quality and its readability. In fact, there are checks implemented in data entry, reducing the probability of errors. Various tools can clarify the discrepancies in the data for identifying, reporting and resolving data issues. This, in addition, makes the process more efficient and reduces the number of in-person visits during a clinical trial.

Facilitates the progression of the trial. EDC systems guide the series of study events during a certain trial, thereby helping experts achieve the study objectives much faster. Most EDC systems have a user-friendly navigation and search options, enabling a user filter to find the required information at a given time. That also limits the time needed for training personnel, which in addition cuts costs. Note that data can also be stored in one location with greater visibility for later analysis and quality control.

 Compliance and Safety.  EDC systems have numerous technical controls that ensure the integrity of data in line with the statutory legal regulatory requirements in research. EDC means safety. Data entry in an EDC system is done on a web-based interface, usually, with the system being hosted online. Qolty ensures that such data is always backed up and protected with restricted user accounts. These features guarantee the integrity of the data collected and its safety – simply because most actions are only permitted by authorized persons.

Features of Effective EDC Systems

Although EDC systems have many advantages over paper forms, some researchers still prefer conventional techniques as they feel insecure about changes, implementation, and costs. Therefore, to eliminate any confusion among experts and patients, EDC systems enable the following vital features:

  • Data entry functionality that enables entry of information into appropriate forms. Note, the study protocol must be set up in the system first.
  • An eCRFs design tool that provides access to eCRFs. In fact, this feature guarantees the adoption of the specific standards involved in the study.
  • A reporting tool to capture, manage and analyze the data collected. The transparency of data has always been the main objective.
  • A graphical and easy-to-use interface. As mentioned above, this feature not only facilitates research but increases the levels of motivation and satisfaction.
  • A validation component, such as out-of-range values and specific codes. Thus, errors are easy to spot and fix.
  • Edit checks are also needed to limit the entry of invalid data. Missing answers and values are an obstacle for a good EDC system.
  • Export of data and safe access. In other words, standards and regulations are followed, while at the same time, multi-centered research is enabled.
  • Query management to support streamlined communication between data managers, monitors, and the coordinators of a clinical study. All with the purpose to help patients and medicine.

            mEDC: Pick up your phone, answer research demands

            During the years, EDC systems have continued to evolve leveraging on the latest Internet-based technologies. The providers have come up with specialized software solutions that can target specific subject profiles or study phases. The rise of wireless EDC systems in clinical trials has also proven to be very useful, especially in countries with unreliable internet access. The development of mobile device-based electronic data capture (mEDC) that is used to capture electronic data by use of cellular phones has revolutionized clinical research.

The use of mobile devices, such as mobile phones and personal digital assistants (PDAs), in such places, has demonstrated great performance in conducting clinical studies. More effective training to the staff, high-quality data, cost-effectiveness, improved user-friendly design, real-time data exchange, and constant monitoring of the study are just some of the advantages of mEDC.

On top of that, with the implementation of apps, data could be collected remotely (via mobile devices) by experts worldwide. This feature is particularly handy in telemonitoring and project management. In fact, a study conducted by Zhang and colleagues (Zhang et al., 2017), which was validated across 14 hospitals and 1333 patients, showed the high levels of effectiveness of mEDC. Although mEDC systems are comparatively new, all parties involved in research show high levels of satisfaction. mEDC facilitates site equipment, patient recruitment, data collection, patient referral, remote validation of data, data storage, data management, quality control, and institutional review board operations.

Electronic Data Capture: Implementation

Overcome Challenges:

EDC systems have many advantages over standard methods for data entry and management. However, the implementation of new tools in research may require training and a focus on technical security. Therefore, finding the right Electronic data capture provider can help you overcome any challenges that may occur (Price & Wilson). We at Qolty guarantee success:

Support through the whole study: Good EDC providers can help researchers throughout the whole clinical trial. From study build, through recruitment, to tech transfer, EDC has many applications.

Best practices: Good EDC providers guarantee expertise not only in the technical side of the EDC software but also in study conduct and clinical trials. The integration of data and research progression are main goals.

Digital data: As manual data capture shows to be ineffective, EDC is becoming a vital factor in the future of research. Successful EDC providers will help experts create a single platform for clinicians and patients, which could enable communication and fast results.

Store Safely: In EDC, the data is stored in a central location. Therefore, information can be analyzed for common errors in real time. On top of that, data management policies ensure data accessibility, security, and protection.

 Risk-based Monitoring: Good EDC providers set a baseline of expected behavior and monitors for abnormalities. As even the best plans can be ruined by unexpected results, as mentioned above, good EDC systems allow researchers to modify data.

Easy & Engaging: With all the mobile-friendly features, browsers, and apps, new EDC systems have a single interface with no pop-ups and easy to navigate options between screens. This can lead to high levels of engagement and motivation in both researchers and patients.

Regulated: Apart from the technology planning in clinical trials, good EDC providers help experts follow research standards, ethical principles, and global and specific regulations. EDC solution providers guide researchers through various geographies and industries, leading them to success.

Summary

EDC systems present the new and tech-driven methodology of science. EDC can enable healthcare organizations record, fine-tune, and ensure both accuracy and safety of data collected during clinical trials. EDC programs have played a major role in various aspects: decreasing the cost of the study, accelerating the productivity of the team, and lessening the overall burden associated with clinical trials. As EDC systems continue to mature, developers are continuously integrating them with other tools, such as clinical trial management systems (CTMS), clinical data management systems (CDMS), adverse event reporting, randomization, submissions, and supply management, which is further improving the impact of EDC systems on trials. Note that rapid import of electronic data from other sources, such as electronic health records, imaging data sources, and lab reports, has also been an essential aim in improving clinical trials. Perhaps EDC could reach the point when electronic patient records become prevalent within the broader healthcare ecosystem; and instead of collecting patient data in a separate collecting instrument, such data could be retrieved directly from the electronic medical records without errors and delays.

References

Allison, M. (2012). Electronic Data Capture: Reinventing Clinical Trials. Nature Biotechnology, 30, 41–49.

Price, J., & Wilson, JC. The New 8 Secrets of EDC Success. Retrieved from: http://go.bioclinica.com/l/171972/2016-08-22/488wy

Shewale, S. & Parekh, S. (2011). Reinventing Patient Recruitment in Clinical Studies. Monitor, 10, 38-43.

Sunil, S., & Sameer, P. (2011). Realizing the Promise: India’s Strategic Shift from Outsourcing to Innovation. The Open Clinical Trials Journal, 3, 13-19.

Zhang, J., Sun, L., Liu, Y., Wang, H., Sun, N., & Zhang, P. (2017). Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges. Journal of Medical Internet Research.