It goes without saying that eClinical is trending as more and more clinical studies seek technical alternatives to traditional paper and spreadsheets. However, among a sea of vendors, it’s often tricky to choose the right one for your research. Below you can find five criteria normally found in an ideal electronic data capture – EDC software/ CDMS that our experts have listed out.
Before you make it cool, you have to get it right. A basic EDC system needs to comply with FDA, EMA and ICH regulations in order to be qualified. Make sure your vendor can prove their compliance with global standards because FDA can always come back and check your trial process before they nod their heads and signs your medicine.
If you are conducting a large-scale study with a huge budget for eClinical tools, then we highly recommend high-priced and professional vendors that have been dinosaurs in the market for years. However, if you are working on a small and mid-sized trial normally seen in Southeast Asia, then consider those solutions with more reasonable prices. You still get the level of efficiency you desire at a cost you sure can afford.
Of course, you can always go for low-priced option even when you are running big. It doesn’t cost to save money, right?
Friendly and intuitive user interface
In order to boost effectiveness, the software needs to provide an easy-to-use interface. Since multiple persons are using EDC including data manager, investigator, clinical research coordinator (CRC), the layout should be intuitive enough to cater for all levels of technological experience. Steps should be straightforward, and procedures should be short and clear. For example, an EDC software/ CDMS may allow researchers to keep track of patients’ visits and statuses by using a color-coding system.
The company should provide training to all personnel involved before they use the system. But the more important thing is that no matter how easy it is to use, problems crop up all the time – that’s why 24/7 support is a big plus. Your top priority is saving time, so immediate assistance will be of great help to boost your efficiency.
If you haven’t known, now is the age of adaptive clinical trial. This means that an EDC should be flexible enough to customize according to the needs of modification within your study. You will want a company that can work closely with your researchers so that any proposed change can be discussed and tackled as soon as possible. After all, you want to pay for an actual improvement in workflow efficiency, don’t you?
Choosing an appropriate EDC vendor is an important decision in the trial process, especially for small and mid-sized studies in Southeast Asia, because a wrong choice results in not only a waste of money but a stagnant trial period as well. Make sure you do thorough research before purchasing your most suited EDC software/ CDMS.
Still wondering? Check out our solution here.