Making the Switch: Selecting the Best EDC

Part 1 – How to Select the Best EDC for Your Clinical Trial Needs?

Looking for the right EDC for your research and clinical trials? Maybe you’re debating the value of switching from paper to an EDC. Sticking with what you know is easy, so using paper makes a lot of sense. And, with so many options currently available, selecting an EDC can seem overwhelming. But you miss out on so many features, if you don’t make the switch! Consider the following key factors when selecting the best EDC for you, your team, and your study.

What Is an EDC?

EDC stands for Electronic Data Capture. An EDC is a web-based software application designed for collecting clinical trial data while maintaining regulatory compliance. It collects your data electronically with devices such as laptops, tablets, and even smartphones. Accessing the data is easy from any location with an internet connection – no need to be on-site to process and review your data.

EDCs replace the traditional method of recording data on paper. Paper forms are replaced with electronic case report forms (eCRFS) designed according to your needs. These eCRFS look like paper forms but offer additional features such as real-time edit checks to reduce monitor workload and calculations to automate routine tasks. Keeping eCRFS organized is simple. Data collection is faster and more accurate. And, chances for manual data entry errors are significantly reduced.

What Makes an EDC System?

When looking for an EDC, you will want to focus on

• Data integrity,
• Fit for Purpose, and
• Compliance

Data integrity ensures that any entered data is traceable throughout the life cycle of your project. A clear record should exist of who entered data and when – maintained in the EDC’s audit trail. This eliminates confusion and satisfies regulators.

Consider Fit for Purpose – a robust EDC functions the way you need it to. An EDC enables your organization to establish consistent processes across all areas of research and build out user-friendly workflows. Consider a dosing calculation. The calculation should work the same way each time it runs – eliminating the need to figure out inputs and more importantly the risk of math errors.

A Compliant data management system can produce results and/or answers that can be submitted to a regulatory authority. In addition to the actual data, there are other regulatory considerations that need to be considered. These include, but are not limited to, electronic signatures, system security, and role permissions.

These three factors should be supported by some of the following capabilities:

• Audit trails
• Electronic signatures
• Queries
• Data upload functionality
• Real-time summaries
• Reports, graphs, and statistics
• Edit checks and calculations
• Automation
• Masking and permissions
• Database locking and unlocking
• Data exports

The best EDC systems are easy to use and streamline data management, with all clinical trial data stored in one centralized location.

What Is the Best Way to Find Out About EDC Systems?

Old-fashioned word of mouth is one of the best ways to learn about any product, including EDCs. Colleagues and peers who have experience with an EDC and recommend it will be able to answer many of your questions.

But, it also helps to do your research. Make a list of your requirements for an EDC. Requirements often include:

• User roles and permissions configuration
• Ability to randomize
• Masking/blinding
• An ePRO or pet owner diary app (a mobile app allowing for direct patient or pet owner data entry)
• Offline capabilities
• eConsent
• Inventory management
• Document management
• Automated invoicing

Then, Google it. You can find EDC websites, reviews, and other valuable information online. Check your requirements list against each EDC to confirm it meets your needs. You can actually make it easier for yourself… Reach out to sales  – send them that list and let them tell you if their product satisfies your requirements.

“Think of an EDC as an extension of your clinical research team. Our Electronic Data Capture system reduces costs, increases productivity, and protects your resources.”

Ann-Marie Kiser, Director of Compliance at Prelude

What Are the Most Important Things to Look for When Choosing an EDC?

When researching EDC systems, first determine what features your organization must have – that list of requirements you worked on. Then, consider cost, ease of use, data security, and the availability of support.

• An audit trail should be on your list of mandatory features when choosing your EDC if you plan on submitting your findings to a regulatory authority.
• Ensure the EDC meets industry-standard security and regulatory compliance. Is the EDC compliant with all the regulatory agencies? Is the EDC system 21 CFR Part 11, Annex 11, ICH GCP, HIPAA, and GDPR compliant?
• Check the EDC company’s reputation. How long has the company been in business? What do reviews suggest about the integrity of the EDC company?
• The testing environment is another consideration. There should be a way to test a study or changes before implementing them in a live study.
• Ease of use is a critical factor in choosing the best EDC. Is the system user-friendly? A user-friendly system reduces the amount of time that needs to be dedicated to training.
• What kind of support does the EDC provider offer? A strong EDC provider will offer training to you on the system. Do they offer a knowledge base? If you have additional questions, who can you reach out to?

How Can You Present EDC Solutions to the Decision-Makers in Your Organization?

The most powerful way to present an EDC solution to the decision-makers in your company is to have the decision-makers test the EDC hands-on. Test driving the EDC makes it easy to understand its value.

A comprehensive demonstration of the EDC is another effective option. Decision-makers can quickly assess the value by seeing it in action. Even joining a meeting discussing the features and benefits of the EDC will allow your organization’s decision-makers to understand the value of the EDC.

Selecting the Best EDC for Your Research and Clinical Trial Needs

Understanding exactly what an EDC system is and what features are included in various EDCs will make it easier to choose the best one for your organization’s needs. Selecting the perfect Electronic Data Capture system is well worth the effort.

An EDC saves time, increases accuracy, ensures compliance, and will make the entire clinical trial process much easier than relying on a paper system. It will enable your research team to streamline clinical trials, improving data quality while reducing operational costs.

Prelude is a leader in Electronic Data Capture systems. Register for our webinar below or contact Prelude to request a demo and discover how Prelude’s web-based EDC can transform your clinical research workflow.