By Deb Borfitz
April 20, 2009 | i3, a clinical research organization (CRO) whose parent is publicly traded UnitedHealth Group, has constructed an impressively convenient e-clinical suite that could replace the need for a multitude of other systems and applications to collect data and manage study activities.
The integrated, web-based solution, known as i3Cube, is currently undergoing pilot testing on several studies with large pharmaceutical firms, according to Cynthia Verst, senior vice president of late phase research for i3 Innovus, the first business unit to implement the technology.
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| Cynthia Verst |
i3Cube sits on a user-friendly Adobe platform and links together best-in-class content management and relational database software for everything from site identification and patient recruitment to data collection, cleaning, analysis, and submission into a single repository. “This is not homegrown, but [an assemblage of] technologies that are tried and true and vetted,” says Verst. The system is being positioned as a “premium value added” trial component of contracting with i3, since no licensing fees will be paid by pharmaceutical companies to use it.One of the beauties of i3Cube is that it will make study sponsors less reliant on outside project managers for staying up-to-date on trial progress, says Verst. “Clients have their own dashboard and can print out their own reports… and will have study progress transparency.”
Although i3Cube is designed to streamline communications and data flow across all clinical development phases, its capabilities are “highly leveraged” in the late-phase arena where scientific immediacy, real-time data access, and ease of use are paramount, says Verst. If the technology proves simple and intuitive enough to “pass the test” with community-based practitioners, then it will surely be suitable for more research-savvy academic sites that might want to use i3Cube for their interventional trials.
The pilot tests underway won’t be putting i3Cube’s drug dispensing, tracking, and management capabilities to the test, says Verst. But they will be vetting the system’s key site identification and evaluation features via i3 InVision, a sister product suite that taps into a claims database containing information on “many thousands” of physicians. This will spare sponsors the “superfluous step” of contacting would-be investigators to ask how many potential subjects they have meeting a study’s inclusion and exclusion criteria.
i3Cube already knows which sites have a viable population and targets them with an electronic questionnaire. Investigators can respond via email, attaching a confidentiality disclosure agreement warehoused on the same system. In addition to expediting the entire study start-up process, i3Cube has e-contracting capabilities. It also has a study library where investigators can go to retrieve documents, including the most up-to-date version of the protocol, and a dashboard with real-time patient enrollment status and their “to-do” list. The CRO can also post important reminders and requests.
All of this, together with the tool’s EDC capabilities, should truncate clinical trial timelines as well as produce higher quality data, says Verst. Time and cost savings from the automation of the site identification process and routine operational tasks is being measured. Earlier-phase pilots will begin when the late-phase pilots conclude in another few months.
“The technology is teaching us how to do things more efficiently and effectively, relative to our industry’s operational processes,” which has created a “wish list” of features to add into future iterations of i3Cube, says Verst. These include the ability of sites to electronically transmit weekly patient enrollment status and screen failure logs to the CRO and the means for operational personnel to get a weekly calendar view of their task lists “to help with time management.”
Verst says i3Cube is an evolving initiative. Subsequent releases over the next 12-18 months will take care of current “gaps” in functionality, including electronic patient reported outcomes. This year, i3Cube will give users cross-trial visibility and the ability to do adverse event data collection and patient randomization via an interactive voice response system component. A future release will make early-phase drug safety studies possible with i3Cube.
Existing study programs, especially the lengthy ones, will start to merge into i3Cube this year, says Verst. “In terms of late-phase research, this is going to be a huge differentiator for us.”