With the changes brought by the Medical Device Regulation (MDR), the demand for systems that can support the collection and management of clinical data is growing. Even though plenty of Electronic Data Capture (EDC) or clinical data management systems (CDMS) exist, it can be an operationally and financial challenge for manufacturers to implement these in their current state.
This post will highlight seven things that Medical Device Manufacturers should be aware of, before choosing a system to support compliance with the MDR and its requirements on clinical evidence.
The seven things to remember when choosing a CDMS
Many existing solutions originate from pharmaceutical clinical trials.
This highly affects the licensing modules, implementation, operation, and possible applications of these systems. Pricing is one of the decisive factors because budgets for medical device manufacturers are usually lower than those in Pharma. Look for a solution that fits your regulatory environment, clinical application, and is flexible in terms of licensing and long-term use. You’ll need a solution that can be applied for smaller studies and post-market surveillance, not only a full-blown GCP clinical trial
Many CDMS and EDC systems require programming skills to set up and operate.
This highly affects the cost of implementation, operation, and support. Make sure to look for a “Do it yourself” and “Made to Measure” solutions, as these will not only simplify your setup but lower the cost as well, due to the fewer “expert” hours needed to operate the solution. In addition, your team will also be better fitted in making adjustments and review of setup, if they understand how to operate it.
Access to live data, status reports, and data export is a must for any manufacturer that needs to comply with the MDR.
Make sure that you can access data within the system without delay. Older systems tend to have migrated multiple software solutions into one, which often results in inefficient software architecture. This can lead to delays in access to data and erroneous interoperability. Furthermore, some systems require you to wait more than 24 hours to access any live data. Modern companies need to be able to access raw data, export, and report without delay, especially if you need to review your data during an audit. You want to make sure that you can log-in and access it without any hassle.
Lack of adherence to modern software design principles, platform support, and availability can highly affect your data quality.
People tend to love user-friendly solutions, whether they contain nice features or not. You can have the greatest system in the world, but if it’s not user-friendly or able to live up to the modern standards for platform support and availability, you will risk lower data quality and compliance. The key to successful implementation is to have all three living up to modern standards. Nice features alone, are not enough.
“Bring your own device” will become a standard in clinical data management.
One of the ways to keep the cost of data collection down is to eliminate the requirement for specific hardware. Especially when you want to involve physicians or patients in your data collection process. This means that a system has to be able to integrate with channels like email, SMS, and APIs to collect data. Look for solutions that support data collection across platforms and devices, without any custom implementation.
Look for a solution that provides more than one method of data collection.
Most vendors provide either only eCRF (electronic Case Report Forms) or ePRO (electronic Patient Reported Outcomes) functionality. Few dare to provide multiple methods of data collection in one or have difficulties in doing so. When the time comes, you want to make sure that you are not limited to a single method of data collection. Make sure you have the possibility to combine both standard eCRF and ePRO functionality, but preferably with additional methods like surveys and integrations with an external data source via APIs.
Full validation by the vendor is a must.
If your data is to be eligible for complying with the MDR, you will have to use a system that is validated. Make sure that the vendor you choose has the necessary quality procedures in place. The system should be verified and validated according to GCP requirements other industry standards, such as security. Ask for documentation if unsure.
To conclude, this is far from being a complete list of requirements for choosing a clinical data management system. There are more individual and product-specific factors involved as well. But, by keeping these in mind, you will at least evaluate and address many of the challenges we’ve seen our own clients experience to date.
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