Tag Archives: Clinical Data

Keith Howells – Senior Vice President of Development, OmniComm Systems

Data Collection, Clinical Trials and Healthcare:

A Conversation With Keith Howells, Senior Vice President-Development for OmniComm Systems

Keith HowellsMr. Howells has almost 25 years of experience in building and implementing applications that support clinical research. As head of development for OmniComm Systems, he is responsible for the TrialMaster product for Electronic Data Capture, and the TrialOne product for Phase I clinic automation. 

Prior experience includes 5 years as head of development for Medidata Solutions and 5 years as head of development for Oracle’s pharmaceutical application suite. Mr. Howells has a degree in physics from Oxford University, England.

Tell us a little about OmniComm; what does the company do?

OmniComm Systems, (OTCQX: OMCM), provides products and services that allow pharmaceutical and biotech companies to collect and manage clinical trials data. At first that sounds rather mundane – how hard can a data entry application be?

But in fact, the task is almost infinitely complicated and infinitely valuable. Whereas most web-based applications know in advance what data they wish to collect – Hertz.com knows you want to rent a car and Hotels.com knows you want a hotel room – we don’t know in advance what data is to be collected because every clinical trial is different.

Maybe the researchers are collecting blood pressure readings, maybe tumor measurements, maybe quality-of-life questionnaires, maybe all three. So we have to first supply a tool that allows customers to define their clinical trial; then we have to dynamically display the data-entry pages as if each had been lovingly crafted by hand. Those considerations, coupled with stringent regulatory requirements, make this a challenging and fascinating business.

In terms of the value, if we can save a month off the research time for a drug that becomes the next Humira, that month saved is literally worth a billion dollars. So we work hard to make sure our products are feature-rich and easy to use, and our service levels are highly responsive. There are a lot of vendors in this space, but we feel we have the right mix of robust capability and nimble responsiveness.

Why did you choose to hold this webinar?

It is remarkable how many different systems need the clinical data, whether for project management, payments to the investigative sites, safety reporting or data analysis. In today’s fast-paced world, you cannot afford a classical software development approach for each of these different data extract needs.

We’ve developed a number of generic approaches such that data may be extracted without programming, thereby providing a much more flexible and productive set of tools. We feel it is useful to share these techniques with interested members of the industry.

What do you hope the audience will learn from this webinar?

A number of the examples are based on our own technology, but we believe this webinar will provide value regardless of which data-collection system a company is actually using. We expect the audience to learn the generic mechanisms by which the raw data can be provided to the outside world, the kinds of re-formatting and manipulation that can be done on that raw data, and the standard mechanisms for extracting the data into other systems.

For example, safety reporting uses an international standard called E2B, and we’ll give a little insight into how that works and how the data is structured. It’ll be enough to educate some people and scare others!

What was your inspiration to get into the industry?

It was a total accident actually. When I was working for Oracle 30 years ago, the company split into servicing different vertical industries and there was no obvious choice for the pharmaceuticals vertical. So I bid for it. I had no idea what I was getting into, but the industry has proven uniquely fascinating, so I never left. It’s quite humbling to see the science and passion supporting the industry we serve, it’s an honor to be part of it, and obviously the mission brings a great sense of value. We’re not directly bringing life-saving products to market, but we’re helping the people who are.

What is the most rewarding aspect of your job?

We get to sit down at a computer screen and, out of thin air, create something that becomes a critical piece of other people’s lives. That’s pretty motivating.

Don’t miss the chance to join Keith and OmniComm in their upcoming webinar ‘Extracting Clinical Data for Reporting, Safety, SDTM & More’.