IBM Clinical Development Blog

The Seven Deadly Sins to Avoid in EDC Adoption

[fa icon="calendar"] Feb 25, 2015 4:54:49 PM / by Amy Young

Topics: Industry Insights, EDC, edc adoption


The Top Line:

  • Easily prevented mistakes can delay realizing EDC’s benefits
  • Effective EDC adoption requires careful planning and a step-by-step strategy
  • Adopting best practices can blunt seven common EDC missteps

Rowers

Picture this: Your organization just selected a killer EDC platform, and you are ready to build and launch your first study. Your team’s been trained, the logins and passwords are set, and everyone’s primed to get this puppy up and running. Greater efficiencies, bigger savings and faster trials are just around the corner!!

Unless, of course, they’re not.

Thing is, we’re all human, and we all make mistakes from time to time. Mistakes executing your first few EDC studies are not out of the realm of possibility, and those mistakes can delay realizing the system’s benefits (and cause massive frustration across the research team).

But with a little planning and preparation, you can sidestep the most common potholes of moving from paper to Cloud-based studies. Avoid these “Seven Deadly Sins of EDC Adoption,” and you’ll find yourself up and running at full EDC speed in a matter of weeks instead spinning your wheels in a roadside ditch.

Sin #1: Underestimate the time needed for training

Think of the interaction between people and technology as a bell-shaped curve. Some on our staff will take to the new system like ducks to water, while others will find themselves barely treading water in the deep end of the pool. It’s easy to misjudge the time your organization will need for training and implementation.

Moreover, training time varies widely among vendors. For some systems that are designed to be intuitive, your folks may only need a few days of training; other systems may require several weeks or even months to get everyone on the same digital page. Make sure this issue is near the top of your list of criteria when reviewing potential vendors.

Sin #2: Reach past the low-hanging fruit

Wanting to bring a new EDC system online quickly and tackle your thorniest challenges to reap its benefits is understandable. You want to confirm the vendor’s functionality claims, services and support as well as demonstrate the value of your investment. As with rolling out nearly any new technology or process, however, starting with a complex, high-stakes study increases the chance of an initial subpar performance (read: #researchfail).

If possible, plan to use the new system with less complex studies at first. There’s a reason low-hanging fruit gets picked first.

Sin #3: Fail to manage expectations

The leadership at organizations adopting EDC for the first time often have very high expectations of how the new system will perform, what its returns will be and how quickly those gains will be realized. Many anticipate new levels of efficiency and speed, and may be “underwhelmed” when longer training and implementation times translate into fewer gains on their first EDC study.

While it’s true some EDC platforms – especially end-to-end, Cloud-based systems built on a common interface – can yield immediate gains, that’s not the case with every system. Operational gains are real, but it likely will take a few trials before your team hits its stride. Make sure that fact is communicated early and often to your leadership team.

Sin #4: Try to use every function out of the gate

Nearly every feature during a product demo looks like it’s easy to use and will add value from the start. But that’s not true in every instance. It’s important that you carefully choose what EDC-related functions to deploy in your first few trials, especially if you expect to use different systems to manage different parts of your study.

Some EDC platforms offer scalable features via on-demand modules, enabling options to be selected or deselected at any time. Others don’t offer such flexibility and may require additional programming to ensure smooth data interfaces. Be sure to set firm criteria when reviewing vendor proposals and methodically evaluate which functions to deploy when.

Sin #5: Assess data only at the end of the study

Although final data sets may tell the most important story, EDC’s ability to provide up-to-the-minute data views affords you extraordinary power to monitor study progress. While you may not be able to tap statistically significant data in early phases of a study, you can track data quality and integrity on a daily basis to catch anomalies or workflow errors. Delivering data on a continuous basis is one of the primary advantages of cloud-based systems. Use it to your advantage.

Sin #6: Ignore built-in communication tools

Many EDC systems optimize communication among staff and stakeholders during a trial. Instead of relying on general email accounts to track and communicate study progress, integrated trial-related communication keeps all relevant and searchable information in one place. Often these capabilities are either overlooked or underutilized.  

A cloud-based system synchronizes data automatically, allowing the team to identify and communicate issues with data collection more rapidly. When key updates and directions are sent into already overstuffed inboxes, your team’s overall effectiveness is unnecessarily compromised.

Sin #7: Cling to old habits

To paraphrase an old maxim says, the definition of inefficiency is doing the same thing over and over and expecting different results. How you did things pre-EDC is not how you should do them now. While it may be uncomfortable for some on your team, it’s vital to adhere to proven best practices with EDC. Trying to integrate old paper-based workflows into an EDC platform is not only counter-intuitive, it’s counter-productive, as well.


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Amy Young
Written by Amy Young