OmniComm Systems Delivers EDC, Safety, CTMS Using .NetWith two dozen employees, OmniComm Systems is one of a handful of public companies specializing in technology for clinical trials. Its ticker is OMCM.OB.
Since its founding in 1997, Omnicomm has been involved in 85 trials with 35 customers. Its stock market capitalization on a recent morning was $11 million, with approximately $1.7 million in revenue in the past twelve months. Booked revenues in the past year were more than $4 million. The stock has basically doubled in the last year, which is not to say it's expensive, recently trading at 41 cents a share.
OmniComm has a goodly amount of Phase I business, which speaks well of its ability to run efficiently in small studies, but it also works in Phase II, III and IV. The company has leveraged Microsoft's .Net architecture. "The .Net platform gives you a far more flexible way of building the studies and to distribute the work. The other advantage of .Net is the ability to integrate with other systems," says Randy Smith, OmniComm's chairman and chief technical officer. .Net allows the company to easily import data from laboratories, patient diaries, and other systems.
Smith adds that the .Net toolset is also better for his customers, which tend to have plenty of protocol-design information in spreadsheets. Smith says that building a study is relatively easy once a bit of information about the study and its case report forms (CRFs) is in hand. "We push the big red button and the system generates the CRFs, patient visit structures, report structures, exports and imports," Smith says. "It's an automated process."
The company is rolling out version 4.0 of its electronic data capture (EDC) software, TrialMaster. "We went three or four years with a very small group of NIH-sponsored customers," observes Rusty Beardsley, OmniComm's executive VP of commercial developing, citing elite teaching hospitals on the east coast. "We developed from the lessons learned on those projects."
Even Beardsley describes the Florida company as a "well-kept secret," much as he is working to change that. He says OmniComm can build trials quickly, in less than a month in many cases, and in as little as days in selected instances.
Beardsley says the company's help desk is not exactly overwhelmed with ringing phones. Largely, that's by design. The platform works. It's easy to use. But in working for contract research organizations, Beardsley says, he's found that they may prefer to be the first point of contact with the clinical site. "We do not have a high expenditure for a help desk," he says. "The product is intuitive, easy to use. That allows us to be very competitive on price."
One of the painful quirks of the rest of the industry, for Beardsley, is that a new, modern technology (EDC) designed to replace an old, creaky anachronism (paper) actually costs more. "We're less expensive than paper," he says. "They're more expensive than paper," he says of competitors.
There's no getting around the issue of EDC pricing. It's an exquisitely sensitive topic. Reasonably or not, sponsors of clinical trials expect rock-bottom prices and completely customized solutions. Beardsley says OmniComm's prices are so low that some purchasers wonder. "Some people are suspicious when they think the price is too low," he notes. Depending on the project, technology for a typical trial might cost $125,000 at OmniComm.
For that fee, the customer would get all setup, unlimited edit checks, forms, cross-form validation, export and import of data and two rounds of user-acceptance testing. There is a messaging system built in, as well as options for adverse event coding and clinical trial management system (CTMS) functionality. Says Beardsley: "We can do an awful lot of CTMS things in TrialMaster without having to have a CTMS."
At OmniComm, he notes, there are no charges to produce a particular report or data point—they've heard the outrage among customers who believed they'd been gouged. "If you want it, you have the ability to get your data on demand," says Beardsley, "without having to come to us or be charged X amount of dollars. The sponsor or the person working with the sponsor is in charge of the data."
In part, Beardsley says, that approach has been driven by customers. "The sponsors are becoming more aggressive about getting control of their data," he reports. "They want to participate in the trial build."
In general, Beardsley says, the company's philosophy is to be a little different than the rest of the technology providers in the industry. "We want our clients to find working with us to be simple, not complicated—and to be a little bit of fun. The last thing we want to do is nickel and dime our clients. Which happens a lot. We just don't subscribe to that."
Entering the OPD Era in PharmaThe financial world, with its seamless global networks and 24/7 trading desks, is the technological poster child around which the pharmaceutical industry should model its systems. It's a stretch, okay? The pharmaceutical industry adores paper and worships double-data entry workflows that would be laughed out of a community bank in rural South Dakota. But a guy can dream.
On Wall Street, there is a well-worn phrase: Other People's Money. In the aftermath of various scandals, most politicians believe there are high temptations for mischief with OPM. Thus, though libertarians may object, our society has guidelines, regulations—yes, even laws about proper handling of OPM. Cavalier attitudes about managing OPM may result in a trip to a local prison (unless you're running a hedge fund, of course).
In pharma, in biotech, we have entered the era of Other People's Data. OPD. OPD in pharma is not regulated. Yet. But it is a transformative force in the life sciences. Once, the clinical trial data of Company ABC belonged to that company alone. That company decided when to release its data. Whether to release it in full or in part. No more. Trial registries and class-action lawsuits and the internet have changed everything by widely disseminating OPD.
Let's take an easy example. Merck has had to deal with a boatload of OPD around its leading painkiller. There is OPD about Vioxx from pharmacy benefit managers. There is OPD from law firms. OPD from the FDA. OPD from academic physicians not involved in the clinical trial process. And Vioxx OPD from insurers. Not getting your arms around OPD about <i>your</i> compound in a rigorous way is unwise. OPD, in short, is like a neighbor's chronically barking dog: you must learn to live with it. It is not going away.
What are the technological ramifications of OPD? In a competitive landscape, it behooves all sponsors of trials, of all sizes, to be proactive in understanding OPD. This cannot be done with Excel spreadsheets and 3x5 index cards.
OPD is not a futuristic concept. A small firm like MetaWorks, based outside Boston, works with sponsors hoping to analyze OPD in the peer-reviewed scientific literature. Likewise, an electronic data capture (EDC) supplier like San Francisco's Nextrials will sync up your safety data with the adverse-event coding engine at Galt Associates. We're sure there are many fine examples of working with OPD with efficiency and automation.
In other cases, our expectation is that working with OPD may prove to be fiendishly complex with no outcome of any assuredly useful insights at the end of the day. What needs to change? Well, we need adherence to standards. Enterprise-wide data standards will prove invaluable to working with OPD. Not just Clinical Data Interchange Standards Consortium (CDISC) standards, although those are and shall remain the most crucial. But HL7 and a bevy of other hospital, insurer and physician standards will also prove crucial, because (by definition) OPD is not generated by sponsors of clinical trials.
Register Now for E-Clinical Track at Life Sciences ExpoThere is still a month to take advantage of the early-bird discount for our upcoming Life Sciences Conference + Expo (Apri 3-5, Boston). Go to http://www.lifesciencesexpo.com for more details.
The E-Clinical Trials and Research track this year looks particularly strong, thanks again to the considerable efforts of Becky Kush (CDISC) and Ken Getz (Tufts CSDD). The confirmed speakers (in approximate order of appearance) and topics are:
* Paul Lammers (Serono) Clinical trials in an electronic era
* Uwe Trinks (Sentrx) Clinical trials 2010
* David Hardison (SAIC) The emerging role of eClinical research data in healthcare
* Gary Lubin (Merck) Capital flows 'upstream'
* Jean Paty (InVivoData) Electronic patient reported outcomes: Documenting the ROI
* John Cline (eTrials) Driving eClinical efficiencies and ROI: CRO and vendor partnerships
* Carol Rozwell (Gartner) TBA
* Rebecca Kush (CDISC) Progress report on standards: CDISC and HL7 RCRIM
* Charles Mead (Oracle) Semantic interoperability between life sciences and healthcare: Hurdles, realities, and promises
* Jason Burke (SAS) Is industry ready for an interoperability platform?
* Paul Bleicher (Phase Forward) Integrating EHR and EDC: Holy Grail or tilting at windmills?
* Landen Bain (Topsail Technologies) Single source and an IHE profile for clinical research
* Michael Barrett* (Critical Mass Consulting) TBA
* Charles Jaffe (Intel) The global trial bank initiative
* Deborah Zarin* (NIH) The International Clinical Trial Registry Platform
* Don Detmer (AMIA) Beyond trial registration: A global trial bank for clinical trial reporting
* John Halamka (Harvard Medical School) The HIT standards panel
* Alan Hochberg (ProSanos) The future of safety data: SRS in an EMR world
* Robbert Van Manen (Lincoln Technologies) Optimizing clinical intelligence in signal detection using hierarchically structured thesauri
* Ramon Dempers (ICM Corp.) Integration to ensure effective drug safety/clinical trials
* Ed Helton (SAS) Producing serendipity: Using clinical data to identify trends and adapt trials
(*invited)
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