EDC is a critical system in your clinical trial,
involving many stakeholders.
But selecting an EDC can feel overwhelming, and the information from vendors can start to sound the same. With help from Bioforum the Data Masters, a data-driven CRO, we’ve put together a step-by-step guide to help choose the EDC that’s right for your study. This resource is tailored for data managers and supporting teams at small to mid-size biopharmas in charge of selecting an EDC vendor.
5 Steps for a Successful EDC
Evaluate your current process
What are the current challenges and limitations of your existing system? Is there anything missing that would be nice? Key areas to focus on:
Ask sites and CROs for their input. You can create a short survey to learn about their pain points. This will help you make the right choice and ease user-adoption.
Determine your requirements
Your therapeutic area and protocol requirements will dictate many of the functions you need.
Prepare for the conversation
The focus of the meeting should be on your requirements. Assume the vendor can handle the basics and spend the meeting digging deeper into your critical functionality.
Often, data management teams have straight-forward questions but can get put off-track by technical lingo or vague responses. See this sample question guide for pointed questions to help.
Pick a challenging but realistic scenario and then ask each vendor to demo how they would handle this activity, not just speak to it in theory.
- "How does data integrate with the EDC – both inbound (IRT to EDC) and outbound (EDC to CTMS, for example)?"
- "How do you handle amendments?" Think of a specific amendment that caused a lot of trouble for your team. Present the scenario to the vendor and have them demonstrate how the system would handle that. You could face extensive downtime and fragile data migrations if you don't do a thorough evaluation of a system’s amendment capability.
- "What are the top 3-5 enhancements that have improved data management processes?" Also, ask for a roadmap discussion and seek to understand how customers contribute to it and new features are prioritized.
NOTE: If you work with a CRO and things get technical, bring them into the conversation to help interpret the conversation.
Consider a workshop rather than working in a sandbox, which will take time to learn no matter how intuitive. During the workshop, have the vendor use a protocol similar to the ones that you have planned moving forward and demonstrate how to build the study, make amendments, handle your complex forms, etc.
Make your decision
Use these four guidelines to weigh the pros and cons of each vendor.
When considering the price, be wary that what you may save initially, you might end up spending on builds and amendments if the system isn't easy to use or requires manual workarounds.
Agile Design for EDC
Agile Design is a new approach to building studies and addresses challenges throughout the traditional build process. The technology and process improvements within Agile Design make it easy to build complex studies, iterate quickly, and deploy updates, which helps your study team become nimble and more successful.
Tanya du Plessis, VP, Data Strategies and Solutions at Bioforum shares the advantages of an agile design approach to building studies.