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The Entire Data Life Cycle: Octagon Research Solutions Leverages CDISC

By eCliniqua Staff

May 22, 2006 | Everything comes down to the difference between what you want to do-and what you actually do. You adore the environment but drive a Lincoln Navigator. You want to eat healthy foods but find Doritos sublime.  

Or you love the idea of clinical data standards, but spend endless hours in internal company debate over why your favorite data element on your favorite case report form must be unique in the history of the science of your pet therapeutic area.  

This is a dilemma they understand at Octagon Research Solutions. In chatting with the company, which has 200 employees, we were impressed by the breadth of their vision for clinical data. It's not a question of clinical data living in one city neighborhood, and painfully moving to another, and then another, like the Okies during the Depression. No. Octagon always has the whole process in mind. Its software and services are process-management tools that incidentally encompass specific applications, files, folders, and documents.  

The company uses the Clinical Data Interchange Standards Consortium (CDISC) tools heavily. Kirk Gallion, Octagon's co-founder and president, says the nature of the industry is that standards adoption comes slowly. "There is a lot of inertia. Trying to get it redirected takes a lot of patience," he says. "We're trying to work with it, as opposed to try to beat the drum about revolutionary change."

The company's ViewPoint product, he says, is an example. It's a different way to organize the clinical and regulatory workflow. "ViewPoint has really helped us put an engine behind these complex, dynamic processes and move organizations along from upstream events connecting the clinical events and regulatory processes," Gallion says. "It's always been intended to orchestrate the people, the cross-functionality technology, and get those working in concert." The software provides real-time metrics, and reporting and search capabilities; it also includes tools for communication and planning.  

The reality in the industry, Gallion says, is that many sponsors and vendors undertake prodigious amounts of hand-tailoring of applications and data. "What we see is people trying to force-fit a lot of customizations of one system," says Gallion. "You're talking about significant customization. We have not seen too many success stories of that." 

Octagon's solution, he notes, embraces clinical data management, clinical trial management, and document management. Says Gallion: "We take the processes organizations already have, and put an engine behind them." In part, that engine has to manage a lot of Microsoft Office documents, except in a more industry-specific way than Microsoft Project. "You cannot use Microsoft Excel and Project to understand the hundreds of thousands of component that go into a submission," he says. "That is where ViewPoint originated." 

The company seems to have put a bit more muscle behind understanding and using data standards than most. Octagon Research Solutions is a CDISC corporate sponsor and a CDISC-Registered Solutions Provider. And the company says it is the primary trainer for the CDISC Study Data Tabulation Model (SDTM).  

David Evans is the CIO of Octagon. He notes that the company is doing some work converting older data into CDISC formats, with more than 15 full-time staffers working in the area. It can take months, he says. Although change is happening almost imperceptibly in the industry, he says it is occurring. "There are companies that are looking to abandon their internal standards," Evans says. "It's more evolutionary than revolutionary."  


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