Implementing EDC systems in Clinical Trials: Benefits, Challenges and Solutions

In 2023, experts forecast that the EDC systems market in the United States, one of the leading countries in EDC implementation, will be worth 350 million dollars, which is nearly 5 times higher than that in 2017. The market value of the EDC systems is expected to continue to accelerate and reach approximately 570 million U.S. dollars by 2025. More clinical research organizations have implemented these systems but what are the exact benefits the EDC systems bring about for these organizations? During the EDC implementation, what are some challenges we might encounter and how to overcome them? All your questions will be thoroughly solved in this in-depth article.  

What is an EDC system?

An Electronic Data Capture (EDC) system is a software application designed to automate and streamline the data collection process during clinical trials or other research studies. 

EDC replaces traditional paper-based forms, enabling impressively faster data entry with the support of several features like online­ recording, data validation checks, audit trails, and role-based access control to ensure data integrity and security.  

Most powerful benefits of the EDC systems in clinical trials

The increasing trials of new drugs and pharmaceuticals has made the management of clinical information become more complex than ever before. This leads to much higher demand for the EDC systems as they help facilitate the clinical research process.

Enhanced data quality: The EDC systems often include built-in data validation checks that can reduce errors during data entry. Whenever an error is detected, the users will be notified instantly to correct that mistake. This leads to higher data accuracy and decreases the need for manual data cleaning later on.

Accelerated clinical research duration: With an EDC system, data can be captured electronically in real-time, eliminating the need for manual transcription from paper forms. Moreover, the templates of Electronic Case Report Form (ECRF) in the EDC systems are easily modified online to suit new studies, which means that organizations do not need to design and produce paper CRFs all over again. This increases the efficiency of the researchers as the feature mentioned reduces the preparation time. On average, the EDC systems cut 41% of pre-study preparation time.

Effortless access to data: An EDC system provides users with real-time access to data. Since the EDC systems are usually web-based applications, users can monitor the data anywhere, anytime, which means they no longer have to physically store all the paper-based forms or go to the organizations directly to search for necessary information. 

Clarified data collection process: A prominent feature of the EDC systems called audit trails enables users to track all modifications made during data collection, so they have a holistic view of what has happened before, during, and after each phase of the study. This function keeps the database updated because users are always alerted about every change that might affect a participant’s conditions. As a result, the study outcomes will be more accurate.

Better cost saving: EDC implementation can be pricey at first but in the long term, it is well worth the initial investment as these systems help organizations reuce an enormous amount of money. The EDC systems shorten the clinical trials time, which means that less money will be spent on those experiments. The Center for Study of Drug Development states that more than 80% of clinical trials failed, causing delayed drug commercialization. This resulted in great loss of revenue for manufacturers. But this issue will be curbed with the help of the EDC systems.

Secured database: All data is saved on secure servers and can easily be restored if one server experiences issues as the systems will automatically copy data to the backup server. The EDC systems also ensure data confidentiality by providing different levels of access rights. When the trial period ends, only a limited number of people are able to view the ECRF. 

Challenges when implementing the EDC systems

High upfront cost: Implementing an EDC system can involve significant upfront costs. Organizations need to spend money on infrastructure building, data migration from other systems, internal staff training,....

Lack of knowledge: For an organization that has always used paper-based forms, switching to an EDC system can be a daunting task. Most of the employees are not familiar with the new features. They might feel unwilling to adopt this technology as their traditional workflow is disrupted.

Incompatible data between existing platforms: Data forms of Electronic Health Records (EHR) are pretty complex, making it difficult to integrate the EDC systems with EHR. In addition to EHR, there are a lot of platforms such as laboratory systems, or data management tools that need to integrate with EDC. 

Data Privacy and Security: Because the EDC systems contain sensitive patient data, maintaining data security and privacy is extremely important. It is mandatory that clinical studies comply with stringent regulations such as the Health Insurance Portability and Accountability Act (HIPAA) that protect patient privacy.

Innovative solutions to address those problems

Cost optimization: All the costs related to EDC implementation should be carefully evaluated before the installation. Some factors people usually miss when planning the investment are licensing fees, maintenance, and training expenses. You should also find reliable vendors that offer flexible pricing models to optimize the costs. In Ominext, we always work closely with our clients to understand the customers and create the most suitable cost-effective strategy for them, while still ensuring the optimum product quality.  

Comprehensive training for employees: The organizations should offer all-around training programs to ensure that all the staff understand how to effectively use the EDC systems. Resources such as user manuals, FAQs, and online tutorials to support continuous learning are all recommended.

Data mapping: To avoid incompatible data integration, we advise you to create a standardized data model and adjust EHR data to match the EDC systems. You can consider using common standards like Clinical Data Interchange Standards Consortium (CDISC) to ensure smooth data transmission and reception.

Compliance with regulations: Safeguarding patient data is paramount in running the EDC systems so you have to ensure the EDC systems abide by relevant data security laws. We recommend you conduct regular audits and assessments to maintain compliance and address any identified issues promptly.

Conclusion

The EDC systems streamline the data collection and management process with several  beneficial functions, that’s why more and more organizations have adopted these systems. However, during the implementation process, some challenges are unavoidable, requiring tailored solutions to overcome these obstacles while still reaping the full benefits of the EDC systems.