With the increasing recognition of the value of using Electronic Data Capture (EDC) systems in clinical trials, it’s no surprise that the number of EDC providers is growing. Whether you’re implementing an EDC system for the first time or replacing an existing system, you might wonder how do you even begin to evaluate which one is the best for your organization?
What Do You Need/Want from Your EDC Provider?
When we asked Bioclinica webinar attendees what they considered to be the most important drivers for EDC selection, “data quality and reporting capabilities” was selected by nearly 100% of the attendees, followed by “data management capabilities” and “price of software and support.”
Based on my experience, within the categories of data quality, reporting and management, the available support and capabilities vary widely between EDC providers. I recommend thoroughly evaluating potential EDC providers against your requirements to ensure you get the features you need at an acceptable price.
What are your requirements?
A good first step is to make a list of the necessary requirements for your organization and studies. What do you need for submission-ready data at the end of your study? For example, one key feature is 21 CFR Part 11 compliance. In addition, data security and regular data backups might be considered essential. If you already have an EDC in place, it could help to ask your team if there are features lacking from the existing system.
Then, create a list of the features that would be nice to have. Ask your team what features are on their wish list! These could include multiple integration points with other systems such as CTMS, RTMS and labs systems.
Systematic Approach to EDC Provider Evaluation
For this need/want list-making process, I find the following five critical questions to be helpful - especially if you’re reviewing EDC providers for the first time.
Question 1: What do I want from the EDC technology itself?
Consider your technology requirements in the following four areas:
- User Friendliness
Question 2: What integrations are needed for my EDC technology?
The ability to integrate the many, often disparate systems used in clinical trials can significantly reduce trial complexity, improve efficiencies and increase data integrity. Consider the extent of integration that you need/want and how any complexities or issues arising from those integrations will be handled.
Question 3: What combination of technology and services do I need?
When you start considering the practical aspect of moving a chosen EDC into your system, there are two broad line items to consider:
- The Technology Itself
- Professional Services
We’ve found that achieving 8-10-week build times is possible with the right technology but becomes more probable when you pair the right technology with the right professional services team.
Question 4: Who will provide the data management services?
Because an EDC system does not exist in isolation, you’ll have to evaluate the data-related systems and teams surrounding and supporting it in the following areas:
- End-to-End Services
- Supported Auxiliary Systems
- Data Transparency
Question 5: How will my EDC provider help get my drug to market faster?
Faster time to market is a key reason to implement an EDC solution in the first place, and the following attributes help with efficiencies:
- Standard Operating Procedures (SOPs)
- Data Availability
Best-Fit EDC for You
Taking this systematic approach to your evaluation of potential EDC providers can break a potentially daunting task into smaller, manageable chunks. Considering both the technology and professional services can help identify the best-fit provider for your organization’s needs and capabilities. Gathering input from your team will help ensure that the chosen EDC is one they will be happy to use.
Bioclinica has been partnering with sponsors for 15 years to provide best-in-class EDC and Data Management services. We have experienced individuals who understand the critical needs of sponsors when evaluating EDC providers. For additional information or to discuss your EDC needs, contact me at Joby.John@bioclinica.com.