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What is an EDC system? 

Electronic data capture (EDC) is the most common method of data collection in clinical trials. While each system serves to efficiently store patient data and streamline the collection process, there are currently over 100 different EDC vendors according to the online Capterra marketplace. Not surprisingly, the features, functionalities, and pricing of these systems varies greatly from one to the other.  

Considerations for selecting an EDC system

Choosing an EDC system can and should be a significant decision for an organization. With the continuous expansion of the EDC market and far-reaching advancements in system features, selecting an EDC vendor has become a complicated task. There are many layers to the process, each with its own set of considerations:

  • End user experience 
  • Availability and integration of data collection methods  
  • Integration of trial management components 
  • Data processing workflow configurability 
  • Flexibility in post-live updates 
  • Data reports and downloads 
  • User account management 
  • Training 
  • Technical support 
  • Compliance and security 
  • Pricing 
  • Hosting options 

Mapping your needs to functionality 

This is a lot to review, and the surplus of systems available doesn’t make it easier to filter through every option, especially when each option is housed within its own flashy-yet-vague marketing veneer. As such, it is best to start by clearly defining the needs of your current clinical trial, as well as common threads for future studies. 

Which fully integrated interfaces and complementary collection methods will you need to support a comprehensive EDC solution? Possibilities include electronic patient-reported outcomes (ePROs), electronic consent (eConsent), survey distribution, offline data collection, and external data import. Which trial management components need to be baked into the system from the start, such as randomization, IP inventory tracking, site payments, event adjudication, document upload and redaction, medical coding, etc.? Some of these EDC features may pave the way for new possibilities in your study design or conduct. Determining these basic criteria is the first step to narrowing down the number of systems and making a more informed software selection.  

Efficient study conduct by a contract research organization (CRO) or sponsor that yields high-quality data alongside robust risk management has many moving parts: user experience, training, data processing workflows, data reporting, and downloads. Thankfully, these can be evaluated through a simple demo of the system or collected from previous experience. However, it is easy to overlook any system imperfections during these evaluations without an advanced understanding of data management. As these system attributes form the basis of any data collection and future data processing, non-optimal functionality can severely impede study conduct and lead to frustrations at the site, inefficient operations, additional costs, or poor data quality. 

It is imperative that every EDC solution is secure and compliant with the right regulations. Vendor certificates and compliance documentation can be requested. Technical support, hosting location, backup, and recovery procedures should be satisfactory to your quality standards. Finally, pricing is a major factor for many sponsors. In addition to navigating the intricacies of license fees, sponsors must also account for build times and the expenses that result from every delay or extension. These collective costs should correspond to the value the EDC brings to your study, which requires you to have a good picture of what you need versus what you want, as well as a deep understanding of how each option stacks up to the competition. 

CRO involvement 

A proactive CRO is continuously evaluating the EDC solutions available on the market. This constant evaluation, coupled with a wealth of hands-on experience, is why a capable CRO can provide insightful, practical comparisons between EDC systems. In fact, consulting a CRO prior to selecting an EDC system and evaluating its procedures has multiple advantages: 

  • Complete and independent comparison of EDC systems by subject matter experts  
  • Trained staff to build and work in the system 
  • Real-world experience with systems as both builders and end users  
  • Optimal responsiveness and technical support 
  • Previous working experience at site networks 
  • Preferable pricing model 

No single system is the perfect fit for everyone, which is why CRO guidance can be indispensable to the selection process. Of course, not all guidance is created equal, and you will end up with much greater efficiencies down the road if you seek counsel from an industry leader.

What does it take to confidently find your way to the EDC system best suited to your MedTech trials?

Reference 

1 Pestronk, M., et al. Electronic Data Capture — Selecting an EDC System. Published 2020 Aug 1. 2019-1117-Electronic-Data-Capture_Selecting-an-EDC-System.pdf (scdm.org) 

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