What is the best EDC software for a clinical trial?
If you need an EDC software, you can contact us at info@klindat.com
All clinical trials require the use of a case report form (CRF).
Until a few years ago, CRFs were paper sheets containing printed clinical trial data forms.
However, with the advance of new technologies, CRFs are now web applications and are called “electronic case report forms” (eCRF) or “electronic data capture” (EDC) systems.
What is eCRF or EDC? In brief, an EDC is a software application used to collect, clean and transfer data in a clinical trial.
Given its high relevance, clinical trial sponsors should choose the EDC that best suits their type of study.
So, what is the best EDC software for a clinical trial?
As with many other matters, the best solution for something depends on its specific needs and resources.
In other words, there isn’t one particular EDC that is better than the others, but rather that the best EDC will be the one that best meets the specific needs of the trial, while also adapting to your budget.
In this article we will think about the factors that should be taken into account when choosing an EDC wisely.
At the same time, we will mention some EDC software manufacturing companies, which may be good options for clinical trial sponsors.
What aspects should be considered when choosing an EDC system?
Necessary functions
First of all, a basic aspect when selecting an EDC is to assess what functions are required for a specific clinical trial.
A clear example would be the requirements of a phase III randomized clinical trial, which requires a randomization system and sufficient capacity to serve a large number of users most likely located in different countries.
Another very particular type of need would be a clinical trial in which patients must provide data themselves, entering it using a tablet. In this case the electronic data capture application must allow patients to access directly.
As you can see, not all clinical trials have the same characteristics and, therefore, a particular EDC may be a very good choice for a specific study, but perhaps not so suitable for another type of project.
The level of integration with other systems
Secondly, the level of integration needed with other systems must be taken into account.
There are EDC solutions on the market with a high capacity for integration with other software applications that are also used in clinical trials.
For example, it is possible to integrate an EDC platform with other tools such as a Clinical Trial Management System (CTMS) or an electronic Trial Master File (eTMF).
Especially in big, and international clinical trials which need many patients enrolled and a great deal of participating hospitals, it is usual to require several systems to be interconnected, so the EDC must have this integration capability.
The services linked to the EDC
Thirdly, an EDC is a software product that needs to be managed by data management specialists.
Implementing and maintaining an EDC is not as easy as just acquiring the software. Additionally, it is necessary to have qualified personnel who can work on the specification, implementation, testing, validation, and use of the tool.
With that being said, the selection of a particular EDC also entails the need for an in-house or outsourced team of specialists who can administer the software.
Some EDCs have a high degree of sophistication while others are simpler, which has an impact on the human resources needed to set up and maintain these systems.
Price
Finally, one factor that is quite relevant when choosing an EDC solution is the price.
Just as there are different levels of sophistication and performance for electronic data capture systems, on the market you can also find EDC alternatives of varying prices.
Therefore, clinical trial sponsors will need to assess the available budget to acquire the EDC tool that they can afford.
What are the essential elements of an EDC?
While important aspects to consider when selecting an EDC solution have been mentioned above, it is worth noting that there are some elements that prove to be critical.
Clinical trial sponsors should ensure that the selected EDC has the features summarized below.
Simplicity
An EDC should be simple, intuitive, and easy to use. The design of the EDC should ease the tasks of every person involved in the clinical trial.
Security
An electronic data capture tool should be secure, including robust security mechanisms. It is vital that the EDC has access control mechanisms that preserve the integrity of the information.
Reliability
An EDC must be reliable, and it is essential that it has a robust backup system. The system must also ensure high service availability.
Regulatory compliance
Additionally, it should be noted that clinical trials are strictly regulated and it is mandatory that EDCs comply with a number of regulations such as HIPAA, GCP and 21 CFR Part 11.
What EDC options are on the market?
Today, there are multiple companies that develop EDCs on the market. Several examples of EDC products are listed below:
Conclusion
The best EDC will be the one that most adequately meets the specific needs of the trial, while also adapting to your budget. It is very important for the sponsor to assess the required functionality, level of integration, linked services and price. It is also essential that the EDC is simple, secure, reliable, and capable of meeting the required standards and regulations.
If you need an EDC software, you can contact us at info@klindat.com
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