Implementing EDC

balancing the strategic with the tactical

Companies must find a balance between realizing the value of EDC without losing focus on the goals of executing their current trials more effectively. Whether using EDC or paper, the ultimate objective does not change: Do the work necessary to successfully complete trials.

The Risk of Being Too Tactical (Running Trials to Change)

Successful EDC implementations are about finding the "optimal balance" between the tactical and strategic.

• Much of the business case for EDC requires not only a shift in data entry, but changing how case report forms are developed and changing when and how data is analyzed. If it difficult to make these types of changes for a single study.
• Not all studies are alike making it difficult to determine if challenges related to EDC implementation are driven by differences in studies or in the technology and process changes required to make EDC a success.
• The ability to capture, absorb and learn from study to study can be difficult when the study team is still primarily focused on the study result first and EDC results a distant second.

The Risk of Being Too Strategic (Changing to Run Trials)

• Sometimes called analysis paralysis, lots of work goes into figuring out what to do but never getting around to really doing the work or making the change. All of the costs of transitioning to EDC are borne upfront with the promise of a back loaded benefit.
• Management has to commit a lot of resources (time and money) up front based on a vision of results. Without concrete results and progress, it is often difficult to sustain this level of resource commitment even when a project is progressing to plan.
• Learning about EDC is conceptual rather than hands-on. What looks good on paper may not work very well in the real world resulting in frustrations and delays.
• Doing it all at once (going big-bang) is simply very difficult for almost any organization to pull off successfully.

Design an Approach That is Right for Your Organization

There are many ways to be successful with an EDC Implementation. Each organization must consider their readiness, culture, budget and capacity to design an implementation approach that best meets their needs. When it comes to EDC, one size does not fit all.

• If high resistance is anticipated or if the corporate goal is to explore EDC functionality, then consider deploying first to Phase I studies. These studies are generally quickly completed and can be done with different systems, yet will allow teams to understand the benefits each software provides without requiring extensive process changes.
• If the corporate goal is to assess how EDC would benefit the organization, then select a software system and implement it on a Phase II or small Phase III study. These studies are complex enough to demonstrate the benefits of EDC and the results can often be compared to similar Phase II or Phase III studies that are being run traditionally. Processes should be redesigned for the study team to optimize the benefits of the software.

What to Expect

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