Checklist for Evaluating EDC for Medical Device Studies

31 January, 2022, by Alexia Chalita

Using an Electronic Data Capture (EDC) system can make a world difference for clinical trials, especially for medical device studies. Unlike the traditional pen and paper method, EDC systems allow for data collection to be streamlined, improving the trial’s overall efficiency. No longer do monitors need to visit sites for Case Report Forms (CRFs), redundant transcription errors will be eliminated, paper and mailing usage will be reduced, and much more.

As you evaluate EDC systems for your medical device study, here is a checklist full of information to keep in mind before you decide.

• Learnability & Intuitiveness 

An important feature to keep in mind when evaluating EDC is the learnability of the system. Regardless of how complex or time-intensive a medical device clinical trial may be, it’s important to find an EDC that your team can quickly learn and adapt to. Consider how long it will take for your team to become familiar with the software and how responsive the customer support team is in the case you need immediate assistance. Going hand-in-hand with software learnability is the intuitiveness of the platform. Clean, simple UI allows data managers to easily navigate and customize their dashboards as needed. Features like drag and drop or custom widgets will save your team time and energy to be invested elsewhere. 

• Customizability & Scalability

When it comes to building studies in an EDC system, having highly-customizable study build features not only saves medical device customers time but also provides delivered eCRFs with high quality data in the exact format required. Easy to use CRF design tools can help support complex protocols and enhance data entry accuracy. Additionally, a system that supports javascript customizations gives your team the ability and flexibility to build out additional customizations based on your study’s needs. Moreover, it’s important to find an EDC system that can grow with your study as needed. As your study progresses, it may require accommodation for larger populations or pivotal studies. In that case, you need to start with an EDC system that can handle complex data while providing advanced tools. 

• Fast Onboarding & Study Builds 

The onboarding process with your EDC provider should be efficient and effective, ensuring your team is properly trained before launching your studies. The system should be easy to navigate and should not require months of training to learn. If issues or questions arise at any moment throughout the study, the helpdesk and support team should be available to walk you through the resolution. Since time is of the essence with clinical trials, customer support and communication should be priority at all times. Additionally, when it comes to building studies in an EDC system, having an easy-to-use interface, coupled with highly-customizable study build features, not only saves medical device customers time but also provides delivered eCRFs with high quality data in the exact format required. Your EDC provider should support fast study builds to ensure your study is up and running in no time. 

Are you ready to start evaluating EDC systems for your upcoming medical device studies? Request a demo of our system today.