IBM Clinical Development Blog

Changing Horses in Mid-Stream: Yes, You CAN Switch EDC Systems During a Trial

[fa icon="calendar"] Feb 6, 2015 1:01:08 PM / by Amy Young

Topics: Industry Insights, EDC


The Top Line:

  • Sticking with outdated legacy EDC systems is no longer necessary even if your trial began with one. 
  • You can switch to more cost-effective EDC systems without delays, interruptions or increased risk.
  • Data-agnostic EDC platforms seamlessly import data from virtually any source.

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The advent of cloud-based EDC platforms has introduced unparalleled flexibility and speed into the clinical research process. With these sophisticated systems, sponsors now conduct studies of all sizes in every therapeutic area and location more easily and cost effectively than ever before.

But some sponsors are challenged “reaching for the clouds” because they believe that having an existing EDC system prevents them from moving to a better EDC platform.

It’s time to make the leap. Not only can today’s EDC platforms help you conduct smarter and more cost-effective studies, but many also can import your current study data quickly, accurately and effortlessly.

Can’t Get No Satisfaction 

Selecting an EDC system often was a trial in and of itself. The process most companies went through was designed to answer one question: “Will the system work the way we need it to?” Few asked the more important questions: “What if it doesn’t work? And if it doesn’t, how long will we be stuck with this broken-down nag?”

Put three sponsors in a room, and you can bet two of them have experienced “EDC Buyer’s Remorse” at one time or another. In general, their frustrations can be traced to two sources: the platform or the vendor (or both).

Problems associated with legacy EDC systems run the gamut. Some sponsors discover their software is outdated and can’t accommodate new demands such as remote access, mobile communications, inline translation and adaptive trial design. Others find their platform’s usability and functionality haven’t quite measured up to what was promised in the proposal. Complicated programming requirements cause delays and frustration; inadequate internal quality checks lead to data errors; and an inability to scale makes the system obsolete for growing organizations.

Other times, problems stemmed from vendors who didn’t deliver what was promised on time or in budget. Or the phrase “customer service” simply wasn’t in their vocabulary. Maybe they just assumed you wouldn’t switch to another system because you were so invested in theirs.

You do have a choice. You can switch to an EDC platform that is superior and more cost-effective with little risk or delay, even in the middle of a study.

Changing Systems Used to be Hard

The decision to change EDC platforms used to be a risky proposition for sponsors, especially if the new platform was another hard-wired, enterprise-level system. Implementation was complex (not to mention costly) and involved a raft of internal teams from clinical and IT to regulatory and purchasing as well as the new vendor, CRO partners and trial sites.

Operational issues such as database integrity, protocol amendments and study management concerns (such as enrollment status, forecasting and safety reporting) complicated the picture even further. Toss in months of additional training and the time needed to rebuild a study, and a decision to change horses in midstream was about as rare as a Triple Crown winner.

Data-agnostic Flexibility: Seamless Migration

Enter the data-agnostic cloud-based EDC platforms. Many are remarkably powerful and flexible systems that let you make on-the-fly adjustments during your study, including how you collect, manage and report data.

And if you choose a platform that’s “data-agnostic,” you can import data from virtually any source, including legacy systems, proprietary enterprise-level programs, open-source software and common spreadsheet programs such as Microsoft Excel®. This type of any-to-any visual data mapping, conversion and integration tool maps any combination of XML, database, EDI, XBRL, flat file, Excel, JSON and/or Web service and then converts the data instantly into the new system. Sophisticated algorithms seamlessly allow you to migrate to the new platform without compromising integrity, validity or time.

Back in the day, switching EDC platforms in midstream was difficult, risky and, if some cases, downright dangerous. Today, however, if your trial needs rescuing or you’re just tired of dealing with that old grey mare, many of the latest EDC platforms can alleviate buyer’s remorse and replace it with a proven winner.

You could even say that once you adopt that new system, you'll be off to the races.


Did you find this information helpful?

You might also be interested in reading one of our FREE White Papers, "Areas of Impact: How Sponsors and CROs Benefit From EDC Efficiencies."

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Amy Young
Written by Amy Young