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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



OmniComm Strives to be a Tier I eClinical Player



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By Ann Neuer

October 20, 2009 | OmniComm Systems is on a roll.  In a few short years, it has essentially come from nowhere and is now positioned as the Number 3 electronic data capture (EDC) player, behind the 800-pound gorillas: Phase Forward and Medidata.   Sales contracts for TrialMaster, the company’s flagship EDC product, have jumped from $4.8 million in 2006 to $18.1 million in 2008, with continued healthy growth slated for 2009.

Stephen_Johnson
Stephen Johnson
“We want to become a Tier I company”, says Stephen Johnson, Chief Operating Officer.  To reach this goal, OmniComm is executing its ambitious plan to grow organically through ramping up internal resources, and inorganically by making acquisitions to expand its product offerings.

To fuel organic growth, the company has spent the better part of three years building infrastructure, and bringing in the right people.  “We’ve gone from a staff of 25 to 105, and revamped our sales team.  We’ve added a new marketing person, and created a consulting group.  Our Help Desk now operates in eight languages, we’ve opened offices outside the U.S., and we’ve added a clinical services support team to oversee all of the operations when we build a study for our customers.  We think this is a differentiator,” Johnson comments.

The inorganic growth—the acquisitions—is intended to help OmniComm move beyond its EDC roots to become an eClinical company.  Within two years the company hopes to have a fully integrated suite of eClinical applications that will share a single data model across all applications.  According to Johnson, no EDC company has been able to completely pull that off yet.

To build its integrated eClinical solution, OmniComm acquired the EDC business of eResearch Technology (ERT) in June; and in August, the company acquired the EDC assets of Logos Technologies, a provider of Phase I EDC software.

The ERT acquisition was a huge win for OmniComm, which now has a clinical data management system (CDMS), a clinical trial management system (CTMS), a safety module, and a front-end portal.  ERT also brings more of a global presence with its 15 European customers. 

Another key benefit of the acquisition is the jumpstarting of OmniComm’s effort to expand beyond its hosted software-as-a-service (SaaS) business model to include a more profitable technology transfer mode of operation.  “Tech” transfer refers to an option in which the customer pays licensing fees to use software and then builds and administers its own studies.  It is part of the company’s “Crawl, Walk, Run” business model, which gives customers a phased approach to bringing EDC operations in-house.

Johnson explains that tech transfer is highly profitable as it requires few resources beyond providing implementation and validation services, and a Help Desk.  This model represents approximately 95% of its newly acquired ERT business, which is the exact opposite of OmniComm’s mostly SaaS business model, a very resource-intensive and less profitable approach.   

“The ERT deal almost jumped us overnight to a 60-40 mix of SaaS to tech transfer.  Our goal is to become a 50-50 mix of hosted services and tech transfer options to be a more balanced organization,” says Johnson. 

The Logos acquisition offers specialty EDC software that focuses solely on Phase I, a niche market with few players.  In these small studies, data may need to be captured at the bedside at rigidly controlled intervals, such as five minutes, ten minutes, thirty minutes, etc., and in a busy Phase I site, it is easy for staff to miss these collection times.  The Logos product allows the data to be captured in a handheld device that alerts the staff to timepoints that can be tracked up to the minute, and can also be integrated with bar code scanners and laboratory instrumentation.

In December, OmniComm is releasing a Web-based version of the Logos application, and in Q1 2010, the company plans to release an integration of the application with TrialMaster.  

With the new resources from ERT and Logos, OmniComm is hoping to realize it goal of coming out with a major release within 18 to 24 months.  “We are in the process of re-writing all of the applications on a single unified platform,” Johnson explains.

Going forward, OmniComm is actively seeking additional acquisitions, and is currently in negotiations.

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