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EDC in Clinical Trials

What do companies want to know when selecting an EDC solution? As a BioClinica eClinical product demonstrator, I meet a lot of sponsors and CROs looking for an Electronic Data Capture (EDC) product to support their clinical trials. EDC systems have become an integral part of the clinical trial process, so most companies I encounter have used them before. Some want to see all the options before selecting a vendor, others are unhappy with the vendor they have been using and are ready for a change, and a few have never used EDC in clinical trials and are starting from scratch.

As EDC clinical trials technology has changed over the past few years, so have the questions sponsors ask about our systems. Concerns about connectivity have become a thing of the past as it is fairly commonplace for clinical sites to have internet access. Ten years ago we were shipping laptops to the sites that didn't even have a computer. Thankfully those days are long gone as the medical industry embraces innovations like electronic record keeping.

The questions asked now can vary greatly based on the EDC experience of the people in the room. Sometimes we see data managers, sometimes it is clinical operations, and sometimes we are talking with outsourcing groups.

What questions are being asked about EDC in clinical trials?
For data managers, most of the questions concern the data cleaning and query resolution process. Since we have data management services internally at BioClinica, these questions are always fun to answer as our teams have refined our Express EDC product to perfectly handle these tasks. Our latest release has a few new collaborative review "bells and whistles" that data managers will find very exciting.

Standards are more than just CDISC
Another hot topic is standards and reuse of forms and edits. This is very important to sponsors as reusing forms and edits can cut down on User Acceptance Testing (UAT) time since the standard forms and edits have already been reviewed. A good EDC product will allow for this and adds a tremendous cost savings to the process.

The ability to build study libraries of forms and edits is critical to companies who want to roll out studies quickly. Building a forms library is more than just picking all the forms that are typically used and putting them in one place. To define a library, we must align the data specifications with the exports and metrics and design forms that can potentially be used in different ways for different studies. Edits need to be robust enough to catch data mistakes, but not overwhelming to the sites. The text used in these edits needs to be carefully thought out to be independent of any single study need. We have some customers using domain guides to standardize all of these elements related to each domain.

Integration is a Key!
A major concern for companies is whether or not the EDC they choose will integrate with other eClinical products they are using such as Clinical Trial Management Systems (CTMS), Interactive Voice or Web Response (IVR/IWR) and Electronic Patient Report Outcomes (ePRO) solutions.

Unfortunately there isn't a good standard for exchanging this kind of data across multi-vendor platforms. Although CDISC promotes ODM for this purpose, most customer's today still use excel spreadsheets or CSV files for the import of external data.

BioClinica makes data exchange possible through Microsoft web services which is a really slick way of sending real time messages between systems. It is really fun to enter subject information in Trident IWR/IVR and see it pop up in Express EDC. The magic behind this is Microsoft web services. I really like this solution because it is a Microsoft standard, so we are not reinventing anything, and documentation for IT groups about this standard is readily available to all.

The state of our industry is very exciting right now with the focus on running clinical studies efficiently and with streamlined data management processes. I'll explore this topic further on April 4th when I host a complementary webinar on getting the most out of your EDC system. Register now for this EDC in clinical trials webinar and you'll learn new ways to maximize the electronic part of data collection.

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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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