Paper-based data collection from clinical trials has somewhat become a thing of the past except if very small studies. In recent times, healthcare providers have been looking into the effectiveness of Clinical Electronic Data Capture (EDC) software for clinical trials, and there are several factors the constitute a successful clinical EDC system.
However, the EDC solution you choose should be effective for it to meet the required objective. Moreover, the magnitude and complexity of data has increased so much that paper-based records are no longer feasible. There are many benefits of EDC systems, but even this advanced system isn’t free of challenges.
6 Factors That Make an Successful Clinical EDC System
When you want to purchase an EDC solution, you need to make sure you’re choosing the right one for your needs. Here are some of the factors that you should take into consideration as they are used as metrics to decide whether an EDC solution has the potential to be successful.
The EDC system shouldn’t be at either extreme of the pricing scale. Where cheaper systems might not give you what you need, the more expensive ones don’t guarantee success either. You need to consider other factors, such as what other expenses the new EDC system might incur for your business.
Ease of Use
The EDC software that you plan to implement should be easy to use. If not, you will need to factor in the cost of training employees. The interface should also be easy, so you don’t have to constantly run after the vendor to carry out administrative tasks.
The product needs to be simple so that the end-user will have no problem using it. To add to this, technical support should be ever-present in the event that you require some modifications or need assistance to resolve an issue that may arise.
The EDC function should be smooth and seamless, addressing any operational concerns you may have. The EDC system should be strong enough so that it is able to deliver information as required by the trial protocol.
Choosing the EDC vendor is an important decision. You should conduct some research and know that the vendor has a reputation for consistently developing high-quality products. This way, you’ll save money in the long run.
The EDC system should be equipped to handle any automated and manual queries both. This allows for easier communication and coordination between managers, coordinators, etc.
The Challenges of EDC Systems
EDC has problems with coordination between EDCs and Electronic Medical Records (EMRs) as EDC systems may not be equipped to extract data from EMRs in an effective manner. Moreover, users that have access are on-site staff. Lastly, EDC systems don’t allow data cleaning at the point of entry.
While the EDC system isn’t perfect, the benefits significantly outweigh the challenges. The key to implementing EDC software is choosing the right product. When you know what constitutes a successful EDC system, you will be able to make an informed decision that will help you achieve cleaner and more accurate data, that too in a more timely manner.