Five criteria to consider when looking for an EDC

Dec 13, 2022
Five criteria to consider when looking for an EDC

Software selection and assessment is a complicated and sometimes confusing process, especially if you have to pick a provider in a hurry or if it’s your first time doing so. We’ve gathered a short list of mandatory criteria for you to check out – and have an excellent start to your EDC selection journey.

  1. Functionality 
  • Is it easy to log in?
  • How user-friendly is the system for the sites and Investigators?
  • Will the data intake process be too complex?
  • Is the query resolution process easy to understand?
  • Is there a helpdesk available?

Investigators could lose motivation if they face too complex and time-consuming system. But the data entry process can be pleasant if the system looks nice and is simple to use. 

2. System setup 

  • How quickly can the system be set up?
  • Does the system allow to export data easily?

EDC setup can take from 3 weeks to several months. The setup should be fast yet keep the quality on the highest level possible since a poorly set up EDC could mess up the whole trial. Ensure the team responsible for eCRF building is experienced and well-trained for this specific system. And remember to test the system and the eCRFs before using the EDC for the project. 

3. Integration and reporting 

  • Can an EDC be connected with other modules: Pharmacovigilance, ePRO, randomization, etc.?
  • Are there any reports available in the system?

It is incredibly annoying to export every single piece of information one by one, and it’s even more annoying when you have to use external providers to make decent reports on study progress. The more options of the inbuilt reports the system provides you, the better. Keep in mind that an EDC can be your initial source of data for the Pharmacovigilance module; it can also contain IWRS and ePRO, saving you time.

4. System validation

  • Is the system validated? 
  • How stable is the system: backups, data center locations, etc.?
  • Is the EDC compliant with all the regulatory requirements and standards?

Always pay attention to the validation of the system, and if you want the vendor to conduct the validation for you, make sure they provide that they can do it. Safety first – you don’t want to lose any data because backups lack or insecure data centers. 

5. Cost wise

  • Can the same functionality cost less? 
  • Is the vendor’s price in the market? 

Comparing prices and functionality of systems is the best way to assess the vendor, though always keep in mind the size and complexity of your study. You may like a pricy system with multiple features, but you might only need a small part of what they offer. However, on the other hand, good systems aren’t cheap – development & regulatory compliance cost time and money, so be alarmed if the offer looks too good to be true.

If you’re looking for a powerful, validated and compliant EDC – it might be wise to consider Flex EDC. Send us a demo request or an e-mail to bd@flexdatabases.com to learn more!

More about Flex EDC

Stallergenes Greer logo
Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF […]

Learn more
AI eTMF Webinar
Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

Join us for an exclusive insightful webinar as we explore Artificial Intelligence (AI) within the Electronic Trial Master File (eTMF) system. Explore how AI can transform document management, simplify processes, and maintain compliance with regulatory standards. What to Expect? Have burning questions about AI implementation in eTMF? This webinar offers the perfect opportunity to have […]

Learn more
AI validation for life sciences – a unique challenge of dynamic nature

What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?

Learn more
how we implenented eTMF
How we implemented eTMF & developed SOPs in 3 weeks for iRenix

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.

Learn more

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.