Decisions, decisions! With so many electronic data capture (EDC) systems on the market, it can be difficult to know which is the right fit for your organization. How do you begin to sort through all the choices and find the right EDC solution? It’s easy to be lured in by the bells and whistles many systems offer, but it is equally important to look at the vendor that developed it. As with any smart purchases, you need to do some homework before making a decision. Here are some questions prospective customers should ask themselves to identify the right EDC software and vendor.
1. What functionality is necessary?
This may seem obvious, but when selecting an EDC system it is important to make sure the software provides the right functionality for your operations that will help you achieve your goals. Analyze the needs of your studies – everything from case report form (CRF) creation to data export. Can you prioritize needs vs. wants?
2. Is the system easy to use?
Choosing a solution that is easy to use and has an intuitive design will make learning the system simple. Straightforward protocol setup, accurate data entry, and efficient query management can mean convenience for your users. Be sure to schedule a demo prior to purchasing to see for yourself if the system is as user-friendly as it’s presented to be.
3. Does the system fully support compliance with 21 CFR Part 11?
Compliance is a two-way street, but has the vendor done their part? Having all the technical controls in place is necessary for a system that holds clinical data you will submit to the FDA. Download this free worksheet to ensure you’re properly evaluating vendors and internal processes before implementing a 21 CFR Part 11 validatable system.
4. How long does implementation take?
Is there software to install that has to be managed by your IT department? A hosted system can ensure data backup and security to get you up and running quicker. Ask the vendor if they need to approve actions or perform additional steps that could result in a delayed study start up.
5. What is offered for training and support?
How much training is required before you can start building studies (and how long does it take to learn the system)? Is there on-going training or immediate help in the system? Is customer service a top priority? Check to see if the vendor includes both customer and technical support with the cost of the software or if there are extra fees.
6. How does the vendor prioritize new features?
Will feedback from you and other members of the user community be included in new versions of the software? Do they collaborate and strive to create successful vendor-client relationships? If that’s the case, their planned enhancements should continually evolve and improve the software, as well as align with your future needs.
7. Does the pricing fit your budget?
Is it a simple and affordable pricing model or a one-size-fits-all contract? If your study changes, how are you charged for things like additional sites? Many companies have attractive pricing up-front, but hidden service fees can end up being a large expense later on. Know the total cost of the system, and make sure there is a clear understanding of which expenses are and are not included.
8. What is the company’s history?
How long has the company been in business? Are they growing? Looking at vendor stability can help you judge if the company is going to be there for you in the long run.
9. Does the system integrate with other systems in your technology portfolio?
System integration between an EDC system and other research solutions, such as your clinical trial management system (CTMS), can reduce duplicate data entry and ultimately increase data integrity, streamline research workflows and enhance communication between departments and teams. Be sure to ask your vendor if their EDC system supports integration with other research solutions you’re currently using.
When comparing EDC vendors and their products, it is important to do your research and consider factors beyond functionality. Taking the time to do a thorough review of each vendor can help you find the solution that is the best fit. By asking these questions before purchasing, you can select the right software that will help you manage your studies now and well into the future.
Editor’s Note: This blog post was originally published on January 3, 2014.
Download our free worksheet to ensure you’re properly evaluating vendors and internal processes before implementing a 21 CFR Part 11 validatable system. This worksheet walks you through the due diligence portion of the validation process to be sure your organization and vendor meet the necessary requirements. Get your copy today.