I have been involved with EDC (electronic data capture) for more than two decades now. During this time, I have been exposed to a variety of systems. On occasion, I get asked what makes a good EDC system. The person asking the question is usually looking for a short list of killer features that any good system must have.

There are certainly core features, but these are so basic and obvious as to be taken for granted. Every system already provides them. Which raises a question: What is it that truly sets an EDC system apart? If all the systems provide the core required features, why do some companies choose one EDC system over another?

Same As It Ever Was

There are a constellation of factors. First, the sponsor’s perception of how well the different EDC systems are likely to deliver the core promised features. Next, the reputation and financial stability of the vendor. Another factor is the cost of the system, ideally, the total cost of ownership. Finally, there is the sponsor’s perception of alignment with the vendor’s strategic vision for how to place and develop the system.

Each sponsor will weigh the importance of these elements differently. Since perception is involved, various reviewers will have divergent impressions of the same details.

So what is it that sets one system apart from another? The answer is a mixture of functionality and perception.  All the systems have a great deal in common, but this is not surprising. Because all of them are trying to solve the same problems and provide similar functionality.

Different Strokes

At the same time, all EDC systems are different. They were developed independently, on different technology stacks, with different views as to how to address individual problems, and different underlying philosophical approaches. They were brought to market at different times, pursuing different market niches, influenced by different early clients.

What sets one system apart for Client A may be immaterial to Client B. Clients C and D may both review the same system, but walk away with different perceptions of how well the system works, or how well it fits into their processes and work flows.

Your Mileage May Vary

Once an EDC system is deployed, the perceptions will harden. Until your organization actually uses an EDC system in full production, you will not really appreciate how well it functions—or what the deficiencies are. Until you’ve worked with a vendor for a period of time, you’ll never know how much of what it says is empty promises and how much is true. I’ve seen cases of EDC users being very enthusiastic about a particular EDC system prior to using it, but doing a diametrical reversal when real-world performance did not meet their expectations. In these buyer’s remorse situations, they often start to think that another vendor’s product, one previously rejected, now looks better.

What disappointed users often fail to realize is that such comparisons are not being done in an apples-to-apples manner. Instead, the comparison is between a present system and an untested alternative.

Let’s be clear. No EDC system is perfect. Only from working with it on a regular basis will you see all of the shortcomings. Once an EDC system is selected, it is best to stick with it and make it work. Frequent switching will only result in frustrated users, retraining, retooling, loss of productivity, and new frustrations.

In The Mirror

All of the major systems on the market can claim to have success stories. Most probably also have some failures. My belief is that any system that meets the core requirements can be made to work. That’s the key: made to work. No product will be ideal for every situation. And EDC software can’t make users work with it properly. EDC is a tool that must be implemented properly and used properly.

At a basic level, the answer to what makes for a good EDC system is … you. You select the system that meets your needs. It must conform to your work flows and technology toolbox. You must capitalize on the system’s strengths and develop workarounds for the weaknesses. You make the commitment, provide the training, and sell the benefits to the rest of your organization. You make it work.

welcomes feedback about EDC and other topics. He has more than 25 years of experience in the pharmaceutical industry, including data management, programming and IS support. He has personally witnessed the evolution from a pure paper process to the development of e-clinical processes.