What is Fully-Configured EDC, and how is it implemented for a clinical trial?
Today, pharmaceutical (among other) companies use several types of clinical data collection system. One of these types is systems for collecting and processing clinical data (EDC systems).
We have previously mentioned that EDC systems on the market can generally be classified into two types: DIY and Fully-Configured EDC. When you understand the difference between the two, you can choose the most effective and economical system for your clinical trial.
In this article, we are going to use simple examples to demonstrate what Fully-Configured EDC is, what its advantages are, and how the system is ready to perform a successful clinical trial.
In this article, we will focus on the Fully-Configured system type and will not talk in detail about the DIY system. So, if information about the DIY system is more relevant to you, find it in the profile article.
What is Fully-Configured data collection system in clinical trials?
EDC systems are divided into two types, depending on who (sponsor or vendor) prepares the electronic system for projects.
Fully-Configured EDC is delivered to the sponsor ready for work, as the vendor is responsible for its configuration and testing. The DIY system is configured and validated by the Sponsor’s team.
Speaking of Fully-Configured EDC, full configuration services for the project are provided along with the system itself. It is the EDC software vendors that customize the EDC system to the requirements of your project, conduct testing, and fully prepare it for data collection. The sponsor provides basic documents (Protocol, CRF, Statistical Plan) and then receive a ready system in the output.
How is Fully-Configured EDC implemented for your clinical trial?
The Fully-Configured EDC is prepared for the project by the vendor team and is delivered to the sponsor ready for work. Although the sponsor does not need to dive deeply into the system configuration, it is important to know the basic steps of preparing an EDC system for research. Knowing what a vendor should do when preparing a project, you can easily monitor the quality of the system setup and understand the quality of the vendor’s work.
Before implementing the data collection system, the DM team conducts the following steps:
- Audit of project documents. During the audit, the team becomes acquainted with the Protocol, the CRF, the Statistical Plan, and compares the requirements of the Protocol with the CRF: whether there are any contradictions and whether all the necessary data will be collected. The preliminary design of the EDC system is crafted based on these documents. If the documentation lacks data, or it is not composed correctly, it is sent to the sponsor for revision.
- Creating a Specification. After auditing the documents, the team adapts them to be configured with the system. Based on the documentation, a specification is formed, where all the requirements for setting up an electronic system are specified in technical language.
- System configuration based on the requirements of the project. Based on the Specification, the DM team sets up all the parameters of the systems: it forms visit matrix, CRF, user’s accounts, etc.
- Validation of all system parameters. As soon as the configuration is complete, all system parameters are checked in compliance with the stated requirements. At the end of validation, a set of relevant reports is made.
- Switching the EDC into production mode. After verification by the sponsor and validation, the system is switched to production mode. This means that it is set up and ready to collect data for a clinical trial.
- User training and technical support. Before starting the data collection, the sponsor conducts training for researchers. It is also possible to organize a test/training period for doctors.
The main advantages of the Fully-Configured approach
The first and main advantage of this approach to working with EDC systems is the high efficiency and high speed of launching a clinical study by optimizing resources and sponsor time.
You do not need to take any additional steps to configure Fully-Configured EDC. You do not need to dive into the peculiarities of international standards, nor know the terminology of data management, nor understand the names of various modules and the specifics of their settings, nor even organize the internal Data Management team.
If you chose Fully-Configured EDC, then all you need to do is to provide the Protocol and the CRF. Also, all the difficulties associated with adaptation and configuration is handed over to the edc software vendor. Due to this, the risks of incorrect settings are minimal, and issues related to user support and training are promptly resolved.
Fully-Configured EDC is worth the cost for any large-scale clinical trial. It will be the most beneficial and economical for multi-center 3-phase trials or long-term post-marketing studies.
If you are seriously engaged in choosing an effective EDC system for clinical research and are actively exploring the market, you will find our White Paper useful: “Comparison: Fully-Configured EDC vs. DIY EDC.”
In it, we compared in detail the characteristics of the two main types of EDC systems. We hope this document will help you in selecting a system and will be useful for a general understanding of the market for EDC systems.