In a recent news brief about Omnicomm Systems, we noted that the electronic data capture company’s technology has been integrated with the with the NCI’s Center for Bioinformatics (NCICB) cancer Data Standards Repository (caDSR).
In checking in with Stephen Johnson, Omnicomm’s senior VP of business development, it’s clear the company aims to lift itself into a higher tier of the industry. Omnicomm has recently hired away employees with marketing and technology experience from four prominent rivals: DataTrak, Datalabs, Phase Forward and Oracle Clinical. That officially constitutes a hiring “spree,” we think.
Johnson himself came from the sales side of Oracle Clinical. “I was the one on the east coast for the last 7 years managing that group,” he says.
Johnson joined Omnicomm after being impressed by the software. “I was just blown away at the functionality,” Johnson says. The company builds studies with a drag and drop wizard, and does so especially quickly, Johnson says. Coding for MEDRA and WHO is built in.
“I’ve never seen an application that has as much functionality as this EDC system has. They have a really slick tool that allows you to bring EDC in house. It is totally programmerless.” He also touts the system’s abilities to manage drug supply; manage sites; and generate MedWatch forms from within the EDC platform.
Like many competitors, Omnicomm has a program with fixed per-trial pricing to work with contract research organizations (CROs). “It’s our solution,” Johnson says. “You can rebrand it with your name. We’ve given these companies a way to have an EDC solution that is competitive. It’s a pay as you go service.”
At Ease In Phase I
The company is keenly sensitive to customers from all quarters of the industry who feel EDC still costs too much. For each phase of research, it has levels of pricing that even we could understand, based on specified numbers of sites and unique case report forms. A large, complex Phase III trial will cost less than $500,000. But the company also has expertise in Phase I, a niche that not every company industry finds alluring.
Omnicomm, of course, can’t shoulder the brunt of an endless, interminable list of change orders to a trial. Still, it studied the typical amount of such work that is generally required on every trial, and realized that most projects have a manageable amount.
Thus the company’s basic price quote includes a built-in number of hours to fix the stuff that needs to be fixed. Above that, change orders cost $150 per hour. Up front, Johnson says, Omnicomm customers have a lot of visibility into what a study will cost.
Omnicomm will never send a surprise bill for $25,000 worth of change orders that took 5 hours to program. “Companies were getting killed,” says Johnson. “Midstudy changes get expensive. It is well known within the industry that the license you pay is not the final price.”
Omnicomm is also at the forefront of compliance with the Clinical Data Interchange Standards (CDISC) and HL7 data standards. The company can populate case report forms (CRFs) with lab data from HL7 systems, for example. That is a claim we have heard from other vendors but rarely. Says Johnson: “We can do the CDISC operational data model (ODM),” he notes. “Very few companies support the CDISC ODM format.”
Without saying anything untoward about Oracle, his former employer, Johnson does allow that it focused on its own solution, and was less than interested in integrating with other systems. We may be understating that point.
Not Fearing Oracle
Johnson will say this about Oracle: “The technology has passed them by. They recognize that. They know Oracle Clinical RDC is not scalable and usable. They are rewriting their interface with no plugins.”
That’s a reference to what Pfizer asked Oracle do to, a number of years ago. Which was build an EDC system that precisely emulated Adobe PDF forms. It seemed like a good idea at the time. But the quicksand Oracle Clinical jumped into at Pfizer’s behest is the most dysfunctional techno-marriage we’re aware of.
Playing Well With Others
Even the NCI project noted at the top of the story is an example. Omnicomm’s systems are providing a way for existing contact information about investigators to flow directly into its EDC system, which is called TrialMaster.
Here’s the key quote from the NCI press release. “This new functionality is just the first step in our adoption of the NCI’s cancer Biomedical Informatics Grid (caBIG) initiative. Our ability to seamlessly interact with the NCI’s caDSR provides users of our TrialMaster suite of products the ability to quickly and efficiently design and deploy new protocols using a library of standardized common data elements and forms,” said Randy Smith, chief technology officer of OmniComm Systems. “This functionality also allows us to participate to a greater degree with the caBIG community as a whole by providing a means of sharing newly created objects developed in the TrialMaster environment, and then publishing them back to the community using the NCI’s standard curation toolset.”
Integration between EDC and an electronic health record (EHR) system remains a controversial topic in the industry. Some doubt these projects will ever be anything but extremely customized efforts. But there is no doubt that EDC-EHR fusion, even on a onesie and twosie basis, may offer potential advantages to sponsors and time-stressed office staff alike.
Small Is Beautiful
Mentioning his largest competitors, and rumors that are widespread in the industry, Johnson says: “They are struggling with their own success. Customers are starting to complain.” Publicly traded Omnicomm, for the record, had about $3 million in revenues in the past twelve months.
The dynamic? Smaller pharmas and CROs, dismayed by less-than-optimal customer service from the biggest names in the industry, are slowly migrating back to firms like his. “It’s the same reason people go with small CROs,” says Johnson. “We treat every customer as if they’re our only customer. We treat every trial as if it’s our only trial. Good customer service is the biggest reason why we do so well. We get a lot of repeat business.”d9A2t49mkex