Mr. Wit: OmniComm Systems, Inc., is a company that produces and markets software and services to the healthcare industry. Our clients are typically sponsors of clinical trials. They are pharmaceutical, medical device or biotech companies. We also sell to clinical research organizations (CROs) that perform trials for sponsors that outsource the execution of their trials. Our most important product is TrialMaster', an electronic data capture (EDC) application ' an excellent tool for simplifying the work to be done in the clinical trial management process. Clinical trials are categorized into phases I, IIa, IIb and III and we cover all of them. These trials are needed to get FDA approval for commercialization of any new device or medical product. There are also Phase IV clinical trials, which take place when a product is already on the market. These trials are needed to screen side effects for a prolonged period of time in large groups of patients, to avoid situations like we have seen with Vioxx.' The pharmaceutical industry also uses Phase IV trials to stimulate the awareness of a new product: in fact these are marketing trials. As the name indicates, Phase I trials are the first stage trials in humans. They are normally short trials to find out about the toxicity and some other properties of a substance. Once you have cleared that phase, you go to Phase II, which is about efficacy. In Phase III, the dosage, side effects, exclusion of groups like children, etc. are studied. After that, FDA approval is applied for. From Phase I to approval will often take eight to 10 years.
TWST: What does OmniComm see as its sweet spot? What is its market space
at this point?
Mr. Wit: The electronic data capture market is probably one of the most
fascinating markets existing today. It is fast growing and replaces the
paper trail method with an electronic one. The electronic method is
real-time and is largely an automated system of collecting data. It is
much faster and enables users to avoid mistakes. To give you an idea of
the market size, we are talking about 30 billion spent annually on
clinical trials in the United States. Somewhere between 7% and 10% of
that is the cost related to data collection. So you're talking about,
let's say, a 2-3 billion market in data collection that will become
almost completely electronic. Right now, only about 15% of the market is
electronic. We have the unusual situation of the benefit of a large and
stable market of clinical trials and an EDC segment that will be
increasing rapidly and will be a multi-billion dollar market in some
five years. OmniComm plans to be a significant player in that market.
Tickers included in this excerpt: OMCM
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