How to choose the right EDC solution?
In the last decade, we’ve seen more and more Electronic Data Capture (EDC) solutions on the market, ranging from “do it yourself” simple solutions to very sophisticated ones that require programming skills.
Each solution has its technical features, its own capabilities in terms of EDC design, data handling, data reporting and global user experience. In this context, choosing the right EDC system can become an overwhelming task, especially when the Database world is not something you are familiar with.
Some pharma or biotech companies will simply choose the well-known (and expensive) EDC providers. Others will choose new solutions that are well-marketed and seem to be very professional and technically strong. But at the end of the day, the EDC quality does not only depend on the price or on the beautiful presentation the marketing team will show you. Let’s start by saying that on top of everything, you should make sure that the system is fully compliant with CFR Part 11. That being said, here are some interesting points to consider when choosing an EDC system.
1. Functional needs
Before all other considerations, an EDC cannot be chosen if it can’t fulfill all technical needs for your specific study.
- Is your study international and multilingual?
- Will patients have to answer questionnaires from home? At specific time points?
- Is the study randomized? Stratified?
- Do you need the EDC to manage the drug/device stock along with the randomization and drug/device allocation?
- Do you consider using an e-Consent to ease the enrollment?
- Does the study require medical coding?
2. User experience
The final user (Principal investigator, study coordinator, monitor) is always in the center when we set up an EDC. The user experience is of high importance and this is a real criterion when choosing an EDC system. Navigation must be intuitive, monitoring should be easy, and graphic design should be pleasant.
3. Study design
If you are the one to design the EDC, you must ensure that the building interface is user-friendly, and that you can easily build your forms and create edit checks or any specific rule without programming skills.
Also, ask the vendor what is the usual time to build a standard EDC, it will give an indication about the platform’s efficacy.
If the design is made by a professional EDC programmer, he/she will advise regarding the design possibilities that can fit your study requirements.
If you have several EDCs to create, it is important to check if the EDC system can store your forms in a library so that the main forms can be reused in a future study.
Also, a crucial point is to check how flexible is the system when it comes to implement changes to some forms or to the global visit design: will you have to re-write the rules associated to the updated form?
Also, make sure that the EDC provider offers a good technical support at your own time zone.
4. Data handling
Data is your treasure. Data will lead to statistical significance, and eventually to the precious approval you want to get for your investigational product.
You can have a breakthrough product in hands, but if your data don’t reflect its performance properly, you will never get to an approval. That’s why make sure the EDC system can issue real-time reports at any time and by your own. Not only raw data, but also filtered data and metadata such as SDV and Query reports.
Pricing is obviously a central criterion. Every company has its own budget allocation for the EDC system and Data Management activities. However, the more expensive EDCs are not necessarily the most sophisticated. Also, not all studies require sophistication. Keep in mind that the total cost may include the licenses, the system implementation, the hosting fees, and the technical support. For some vendors, the price depends on the number of users, the number of patients or number of visits. Also, some vendors sell licenses with a minimum of one year whereas others sell licenses per month, which is more attractive for short studies.
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