The giving way of electronic data capture technology to e-clinical solutions opens up a software-architecture debate: Integrate vs. unify. It's a fundamental bottom-up/top-down issue.
And it's a line in the sand between clinical trial software providers. "Unified clinical research suites built on a common platform and architecture provide the benefits users seek," Chris Wilke, CTO at DATATRAK, tells FierceBiotech IT in an interview.
DATATRAK provides just such a top-down system in its single-database, single-interface enterprise platform. The unified architecture contrasts with that of systems from such e-solutions providers as Phase Forward and Medidata, he says. Their respective solutions--InForm Global Trial Management and the Rave-centric trial planning software suite--represent the systems-integration approach.
At the recent Life Sciences Technology Insight conference in Boston, IDC research director Alan Louie proposed that, over time, e-clinical systems will feature increasing interconnection. "Standards are helping to enable interoperability but custom integration is still required," he said, as we reported.
"Maturing standards may ease integration but they do not eliminate the need for it," Wilke counters. He recalls clinical technology in the late 1990s. Standalone EDC systems were just gaining traction, he says, as was automated randomization. Systems-building for a clinical trial was a highly fragmented process. "Sponsors had to contract with multiple vendors."
Meanwhile, DATATRAK took an existing horizontal business-automation platform and retooled it for drugmakers. Core functionality comprises what Wilke calls a "single-mold" collaboration platform; platform components provide for EDC, data management, randomization, and other clinical trial functions.
Though it may at times appear to be a semantic argument, Wilke notes the infrastructure implication: The unified DATATRAK one-password-for-all system is scalable, and therefore less of an issue for the "evolving IT snowball" rolling through pharma companies.
He says that some drugmakers did "a good job" of interconnecting disparate e-clinical technology parts for their own use, "but even the big ones had trouble tying it together." They shifted the tech challenge to big CROs, and eventually the challenge was taken on by solutions providers that began building up to broader e-clinical functionality from data capture technology.
But Wilke maintains the superiority of the unified approach: "It enhances the safety, simplicity and speed of clinical trial development by eliminating the moving parts that add overhead, reduce reliability and hinder the user experience."