By Deb Borfitz
February 23, 2009 | Larger trial-sponsoring companies might be happy to learn that OmniComm Systems has created a centralized Clinical Data Hub providing real-time access to clinical data.
“Sponsors can use the Hub to integrate EDC data from OmniComm’s TrialMaster with their own systems and repositories and can generate exports including SAS, CDISC [Clinical Data Interchange Standards Consortium] SDTM, E2B Safety Data, HL7, and other commonly used data standards,” says senior VP technology, Thomas Wells. “This Hub will also act as a CTMS- [clinical trial management system]-like solution to allow companies to track and report on real-time metrics related to their clinical trial and operational data.”
Wells adds, “Smaller to mid-size companies that are increasing the number of studies annually—and currently make up the bulk of OmniComm’s clientele—will more likely use the clinical data hub as a repository for data aggregation. The larger organizations can use this Hub as a way to allow for interoperability across their eClinical solutions.”
The “multi-functional” hub abides by all industry standards for data integration, including CDISC/CDASH, HL7, and E2B safety standards used by various safety systems such as ARISg, Oracle AERS, and Relsys Argus, says Wells. “By leveraging these commonly used standards, it will be much easier for our clients to integrate and aggregate data across multiple eClinical solutions.”
TrialMaster, in combination with the Hub, will offer an “end-to-end solution” from designing electronic case report forms (eCRFs) that support the CDASH naming conventions to supporting the export of CDISC SDTM, the submission method preferred by the FDA. TrialMaster allows for CRF data to be reused and combined with operational data to better assess trial progress and help move critical decision making “upstream,” well before data lock.
“Data integration is one of the key and costly issues companies face today,” says Wells, former director of R&D Informatics at Amgen. “The Clinical Data Hub is a much easier and more cost effective approach to data consolidation than, say, the Oracle Life Sciences Data Hub or the SAS Drug Development platform. [It] will enable life science organizations to make better decisions based on more accurate and timely information as well as to identify and automate repeatable tasks.”
The Hub also provides sponsor companies with “persistent views” of clinical data, improving reporting and export capabilities, says Wells. The solution was developed on an all-Microsoft platform using a .Net framework and SQL Server and SQL Integration Services.
OmniComm may be the only EDC provider to offer an integrated EDC and data hub solution for data collection, integration, and consolidation, says Wells. TrialMaster itself offers a blend of functionalities beyond data collection and cleaning, such as CTMS, coding, serious adverse event (SAE) tracking and MedWatch reporting, and randomization for patient enrollment and inventory tracking. “Our goal is to offer our clients a solution that doesn’t just capture the data, but focuses on what to do with it after it has been collected. This is where most EDC vendors fall short.”
Despite difficult economic times, OmniComm has enjoyed strong financial growth in recent years, says Wells. During a record-setting 2008, the company reported $18 million in signed contracts—an 80% jump over 2007. OmniComm’s employee headcount has doubled in the past 18 months to 90 global FTEs. “We expect to be closer to 140 employees by the end of the year,” he says, adding that the company is “fully confident” that its explosive growth will continue throughout 2009.