By Ann Neuer
August 25, 2008 | Octagon Research Solutions aims to bring greater efficiencies to the clinical development supply chain with the launch of its ViewPoint Quantum platform and CheckPoint Data Validation Services. Both are the latest additions to the company’s portfolio of submission management products designed to accelerate timelines through significant process improvements across the enterprise.
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| Kirk Gallion |
ViewPoint Quantum is a modular system built on service-oriented architecture that eventually will be the backbone for a multitude of integrated upstream and downstream functions in the drug development lifecycle. This includes everything from data collection, authoring content, and publishing of content to submission. Kirk Gallion, co-founder and president of Octagon, says, “This is a big change from the traditional throwing things over the wall. It is software that maintains visibility for everybody in the process so it becomes a more real-time collaborative way of executing plans and achieving what we call just-in-time resource management.”
The first suite of applications based on ViewPoint Quantum is Accelerated Publishing. Slated for launch in fourth quarter 2008, Accelerated Publishing is not another point solution that automates publishing tasks. Rather, it is a collection of process-oriented tools that pulls cross-functional content toward submission.
In the next few months, the company expects a process integration of CheckPoint, a data validation service, into the ViewPoint Quantum platform. CheckPoint is designed to validate clinical trial data against the Study Data Tabulation Model (SDTM) format, a standard developed by the Clinical Data Interchange Standards Consortium (CDISC). SDTM is the electronic format preferred by the FDA for datasets supporting an electronic common technical document (eCTD) submission.
The agency has published a draft of the 105 data checks and four additional checks specific to data loading into Janus, FDA’s pilot standards-based clinical data repository, rendering data acceptable for submission. Recently, FDA announced that a proposed rule on submission of standardized clinical study data, expected in September, will name SDTM as the required format for standardized clinical content.
This is good news for Octagon, whose CheckPoint three-tiered service offering launched in June. Level one entails conducting the basic validation of the required 105 FDA checks, plus the four Janus checks. The second tier provides validation of more than 300 checks to verify SDTM compliance. CheckPoint’s level three is an expert consulting service whereby Octagon works with clients to resolve issues once datasets are validated.
Anthony Chow, manager of data integration and standardization, says the additional 195 checks offered in the second tier were developed during the process of converting data from 250 clinical trials into SDTM format. “We have converted more than 3000 SDTM domains of data, and through the course of massive production, we learned that there are additional things that we need to check to verify SDTM compliance,” Chow explains. He is referring to additional checks to cover safety and non-safety standard domains defined in the SDTM implementation guide and verification of all variables with SDTM controlled terminology.
Initially, checks were done manually, which took approximately one hour per domain. With demand for the service growing, Octagon recognized that greater efficiency with the SDTM conversion work was imperative, so a team was commissioned to look into ways to accelerate the process. According to Chow, “We have now automated the 300-check process and reduced the time to five to ten minutes per domain.”
In the coming months, the company will offer commercial license options for the software used in CheckPoint’s first two tiers.
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