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OmniComm Systems: Transforming Pharmaceutical Industry with Innovative EDC Suite

CIO VendorStephen Johnson, President & COO
Today, the role of the Chief Information Officer in the life sciences industry has greatly changed. CIOs are now integral to accelerating their business’ growth and are tasked with driving value throughout the organization. They are consistently improving processes and workflow, accel¬erating time to market, reducing operating costs, ensuring compliance and identifying new business opportunities. Life science technology leaders have a unique op¬portunity to provide real business value by evaluating how emerging technologies can benefit them and change the way their organizations do business.

“Alongside focusing on growth opportunities in the emerging market, CIOs are pursuing break through innovation, revolutionizing the traditional sales, marketing, and R&D models,” says Stephen Johnson, President and COO of OmniComm Systems. The company provides best-of-breed Electronic Data Capture (EDC) technologies purpose-built for a firm’s unique clinical research environments. Through their innovative cloud technology and advanced API web services, OmniComm offers clients with information to make insight-driven, clinical data-based decisions, bringing faster medical therapies to patients with lower risk.

According to Johnson, with technology advancements, it is imperative to improve the quality of data while reducing risk and cost. OmniComm has added new features in their technology to leverage key initiatives outlined by the FDA, such as eSource data and risk-based monitoring. “For example, in our TrialMaster®EDC, an enabling technology solution for clinical research organizations, we have added a risk-based monitoring module that enables randomized monitoring plans based on key risk indicators,” explains Johnson. “This allows our clients to reduce their clinical trial monitoring workload and overall clinical trial monitoring costs, while improving data quality.” The TrialMaster EDC platform contains major new functionalities that include the ability for patients to enter their own data directly into TrialMaster - ePRO.
The platform also helps translate any trial into any number of foreign languages with the ability to detect and automatically transmit serious adverse events to a safety system using industry-standard E2B format. “TrialMaster’s latest version provides new capabilities to capture audit trail information for electronic source data,” says Johnson.

OmniComm develops technology that transforms the way their customers do clinical research. For example, OmniComm developed a module in TrialMaster that allows clients to automate the costly and labor intensive process involved with generating exports in SDTM format. “In the past, generating an export was done at the end of the study, taking months and tens of thousands of dollars,” explains Johnson. “Now, with TrialMaster Custom Export Utility, our clients can automatically generate exports upon demand.”

EDC and other eClinical technologies aren’t just enabling our clients to reduce costs and be more efficient, they are transforming the way in which they do business


The company also introduced central monitoring with auto-redaction, revolutionizing the way which source document verification is done. With this module, clients can pull up an image of the source document from within TrialMaster to monitor against the eCase Report Form. Johnson adds to the numerous benefits of TrialMaster through their ePRO module where now data can be collected directly from the patient and stored with the EDC collected data in a single database without having to provision hardware or utilize costly IT projects to merge the data.

The company is presently working on a solution that will allow their clients to deploy OmniComm’s technology on any mobile device without the need to develop individual apps to support each mobile device. The interface will automatically adjust to accommodate the device being used. The company is also redesigning the user interface to improve user experience and productivity. “We are also invested in several long-term projects to integrate electronic health records with TrialMaster EDC. We want to offer our clients the most innovative solutions for the years to come,” concludes Johnson.