How do you go about selecting the best Electronic Data Capture (EDC) system for your study? There is now a vast amount of choice in the market, and many factors to take into account before making your decision. Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.
In general, it's important to consider the points below:
The Basics
Cost: This may be one of the first aspects which are considered. There are many different pricing models available, with Licensing, Subscriptions, Pay as You Go and Pay per Protocol all familiar approaches.
Operational Features: Can the EDC system deliver what is needed for the protocol in question? Conversely, does the system deliver too much for the protocol?
Technical support: Is the system fully supported in the manner in which you need it to be? This is an important area to research from both the development as well as the end user perspectives. How are modifications made to the product? How long is the average time to obtain an answer from the support team?
Implementation Ease: What level of understanding is needed to build and deploy a protocol?
Vendor Stability: This is crucial. Is the vendor going to be around as long as you need them to be? Will there be considerable changes made to the vendors’ procedures or pricing?
Beyond the EDC system
The EDC system may be the lynchpin of data collection for the clinical trial, but many platforms go beyond capture of CRF data. It's important to consider how important an integrated approach is to your study. An up-front discussion is invaluable to discover whether features such as integrated ePRO, IVRS or coding tools are key factors to the protocol’s success. The costs involved in integrating may be well spent if looking at the cost and process of more manual reconciliations.
Different Stakeholder Needs
In addition to the above points we have to remember that different stakeholders have different priorities and pain points.
What does the Clinical Site want?
- User friendliness is of vital importance to clinical sites. A clinical site may be using multiple systems, and they need They need to be able to address the data requirements around seeing their patients. If the EDC system becomes a barrier to their progress, it will be hard to get them to stay up to date with their entry.
What does the Clinical Data Manager want?
- User friendly, easy to develop systems.
- Enough function in a system- (but remember, more than enough is not necessarily better).
- An EDC system which is easy to train on and intuitive to sites and clinical monitors.
- Robust reporting – in standard reports as well as the ability to easily create custom ones.
- Systems which allow for easy integration of changes in while maintaining integrity of earlier versions.
What does the Statistician want?
- Reliable data extracts in the formats they need
- Robust reporting
- Data extracts which haven't been negatively affected by protocol change
Cytel Data Management can help you navigate the technology requirements of your study. To find out more about our Clinical Data Management solutions click below.
With thanks to Patti Arsenault, Director Clinical Data Management at Cytel
Further Reading
Blog: Data Standards and My Experience
Blog: Data Management and Biostatistics- promoting quality
Blog: 5 Key interactions of data management and statistics
Blog: Overcoming DM challenges in Oncology Studies
