Standards Adequate for EDC Adoption, Advocate Says

Standards are mature enough now for businesses to embrace electronic data capture (EDC) and feel the positive impact almost immediately, Fast Track CEO Ed Seguine told PIR. However, many in the healthcare industry believe that technology has not reduced the complexity of the clinical trial process, he noted.

Technology must address the source of the interconnection in the clinical trial environment. Currently there are many interconnections and dependencies, and process complexity has been an argument against making any kind of bold leap into EDC, he said.

However, EDC should be leveraged as a catalyst for process change, he argued. It can be a “framework for addressing broader collaboration issues,” he said at DIA’s June conference in Philadelphia.

Also in June, Fast Track demonstrated the automatic setup of OmniComm’s TrialMaster EDC solution through a standards-based import of protocol information from Fast Track’s TrialSpace Designer. The automatic trial setup was accomplished via a Clinical Data Interchange Standards Consortium (CDISC) ODM-based file containing the detailed trial structure information including visit, task and edit check details captured as the protocol was created in Designer.

“This is the first meaningful example of the ‘vision’ of an integrated electronic clinical development environment,” Seguine said. “This is an important milestone demonstrating the immediate relevance of CDISC standards and the business impact that standards-based tools can have. Looking ahead, the focus will shift to ‘what’ information to share not ‘how’ to share it.”

Fast Track’s TrialSpace Designer provides consistent data end-to-end in an MS Word interface, Seguine said. “If ours falls apart you have a Word document in the CDISC standard,” he said. CDISC is working with the FDA and industry on advancing standards in healthcare IT. Seguine said he’s been involved with CDISC from early on.

Boasting what he called strong audit trails, Fast Track Vice President Charlie Beitz said TrialSpace Designer is Part 11-compliant. They are focusing on top 20 pharmaceutical and biotech companies in their marketing, he added. — Michael Causey