OmniComm Systems: Transforming Clinical Research through Innovative EDC Solutions

Steve Johnson, President & COO
It is no secret that the complexity of clinical trials continues to increase. “Increasing complexity and rising costs in clinical trials is a major industry issue,” comments Stephen Johnson, president and chief operating officer, OmniComm Systems. As a result, there is escalation in the overall cost of conducting clinical trials and bringing drugs and devices to the market. “Companies are striving to adopt technologies and processes that facilitate getting drugs to market faster while driving down costs,” he adds. The answers to these industry challenges lie with OmniComm. The company’s technology—at its core—is designed to improve operational efficiency, productivity and reduce overall time to market. “Our technology solutions make electronic data capture (EDC) more attractive to research organizations and helps drive down costs,” asserts Johnson.

OmniComm’s core product— TrialMaster®, which includes modules like TrialBuilder and TrialExplorer—is architected for one purpose—to help solve the problem of increasing clinical trial expenses and bring drugs to market quickly. Aimed at Phase I through Phase IV clinical trials, the innovativeness of TrialMaster makes it unique in the market. “We are debunking the ‘EDC is a commodity’ myth, “states Johnson. “We are decommoditizing EDC.” For instance, OmniComm has built a Study Data Tabulation Model (SDTM) export utility within their product that automates the way submission-ready datasets are generated. Following the Food and Drug Administration’s (FDA) mandate that requires clinical trial data to be in a standard format, most companies spend a considerable amount of time and energy in getting their data into the recommended format. In such situations, OmniComm’s acclaimed SDTM export utility solution becomes highly valuable.

In similar vein, Johnson highlights a case involving a Boston-based biotech company that was generating clinical trial data and transferring it to vendor third party vendor to create submission ready data.“The company would spend upwards of $150,000 to $200,000 and take over 4 to 6 months just to convert that data into a submission-ready SDTM format,” says Johnson.
By adopting OmniComm’s technology and building these directly into TrialMaster EDC, the biotech company was able to generate SDTM datasets within a few days rather than months. “It reduced their costs by about 75 percent,” reveals Johnson.

Recognizing the need to be leaner and agile to gain a competitive advantage over established enterprises, Johnson steers his company towards delivering technology that is superior to that of their competitors’. “Over 30 percent of our investment goes into R&D,” he notes. OmniComm has had 14 major releases across their product lines over the last five years. This shows the company’s dedication to continuous innovation in reducing costs and expediting clinical research. “Moreover, as ‘EDC Specialists’, we offer three distinct EDC platforms designed to meet the diverse needs of our clients,” says Steve Johnson. While many companies use one EDC product across every type of trial, OmniComm EDC solutions are built for purpose to meet the variety of clinical research needs. For example, TrialOne® is specifically developed to automate Phase I clinic operations. Today, many top Phase I clinics in the world deploy OmniComm’s TrialOne technology. “We have a product called Promasys that is geared towards investigator initiated trials,” adds Johnson. “Unlike others, we have the right EDC solution for the right job.”OmniComm also has a commendable customer focus, through which they try to resolve virtually every call at the point of contact.


We have the right EDC solution for the right job


Amidst constantly changing market trends and FDA’s new guidance, OmniComm is committed to delivering technology that will enable their clients to ensure compliance in the face of changing regulations.“To compliment FDA’s data capture policies, we have built functionality within our technology that captures data directly from a variety of monitoring devices,” says Johnson. In fact, the company is set to release a solution that will allow capturing of data directly from the patient—a patient-centric data entry interface.

Company
OmniComm Systems

Headquarters
Fort Lauderdale, FL

Management
Steve Johnson, President & COO

Description
Provides comprehensive solutions for clinical research with extensive global experience from over 4,000 clinical trials.