Data Communique Tool Bridges EDC, Paper Clinical Trial Initiatives

Electronic data capture (EDC) proponents may have oversold the technology as a “panacea” to cure all etrial operational challenges, but the reality of user difficulties and technology aversion has slowed EDC adoption, experts told PIR.

“Fifteen years ago everyone said paper was done,” recalled Richard Skolnik, executive vice president for marketing at Data Communique International. But the reality is that certain trial sites will still only use paper, while others are open to a hybrid of EDC and paper.

“EDC usage has peaked for now because users are frustrated” with the technology, added Data Communique CEO David Curran. His company has just rolled out a case report form (CRF)-Bridge application designed to bring together EDC and print in a single workflow. CRF-Bridge eliminates the need to choose between EDC or paper, Curran said, while providing a cost-effective single point of contact for managing data and trial demands. CRF-Bridge is Part 11-compliant and features strong audit trail abilities, he said.

Antiquated Case Report Forms

“In the market today, many companies feel that they are stuck with a choice between EDC and paper,” Curran said.

At the top of the problem pyramid for sponsors and contract research organizations (CROs) is how to modernize case report forms. Many CROs are still using relatively antiquated systems and are reluctant to dive in with the big upgrades and training oftentimes required for EDC.

Drug and device firms would be well-served to think less about EDC as a technology and more as a change management tool, Curran said. Smaller firms tend to have a more proactive approach to EDC because they are generally less entrenched in their operations and organizational chart.

CRF-Bridge can help “minimize the pain of change,” especially for technology-averse personnel, Curran said. “Technology like EDC is intimidating,” he said. “Our tool can help bridge the gap between paper and EDC and ultimately move more people toward acceptance faster.”

Pharma Slow to Evolve

It’s a tall order because the pharmaceutical industry is not generally considered to be at the forefront of technology and innovation, experts generally agree. “Pharma tends to mimic other industries like finance and insurance when it comes to technology,” Curran said.

Despite the fact that it has been widely discussed for more than five years and is already in operation at many pharmaceutical companies, many drug and device firms still view EDC as a “pioneer” technology they aren’t quite yet ready to deal with, Curran said.

CRF-Bridge integrates with existing IT infrastructures using the web-based ASP model. It also tracks inventory and shipments, while facilitating print, storage and distribution. It supports PDA data entry and interactive voice recognition.

It also supports more than a dozen clinical drug development processes, including data management, an integrated EDC-paper system, online inventory management and online tracing. — Michael Causey