CWWeekly’s occasional Q&A feature, Three Questions, interviews executives in the clinical trials space. Staff Writer Ronald Rosenberg sat down with Glenn Keet, CEO, Clinovo.

Q: Earlier this year, Clinovo launched a new version of its cloud-based Electronic Data Capture (EDC) system as a free, fully validated system to manage electronic case report forms (eCRFs) without the need for a professional or specific IT service. Having a free version of ClinCapture launched and now used in 128 trials, please explain the company’s revenue model, add-on services and your self-service portal.

A: The number of new clinical trials is growing every day as people sign up to deploy studies on our platform. Under our “freemium” model, we are giving away free EDC software and free do-it-yourself tools to anyone who signs up. Our goal is to try to enable our clients to be able to do much of the study work themselves so they can deploy it with the least possible startup costs.

That is what our revenue model is all about. We are trying to entice people who run clinical trials to use our platform by reducing their startup costs, and then to become paying software clients through upgrades of features or functions.

Our revenue model structure is such that we collect monthly license fees for our software when they choose to upgrade to either our Premium or Ultra tier of features and functions. Additionally, if after time they collect sufficient data within the trial to cross through a size threshold, we would then start charging fees.

Our self-service portal allows clients to sign-up to use ClinCapture EDC to build and deploy their studies and put them into production without having to pay anything. That gives them the confidence that the product will meet their needs, that they can begin collecting data in an EDC system, and understand that they can succeed less expensively than doing it on paper.

Not only is our self-service portal for building and deploying studies, but also for purchasing advanced features—they can do it by simply using a credit card or supplying invoicing information.

Q: What are the misunderstood issues about the opportunities for using eSource and electronic health record (EHR)/electronic medical record (EMR) data?

A: Probably the most common misunderstanding is that it [integrating an EHR] is too difficult to be able to accomplish, particularly for a small trial. There are many EHR systems out there, and it could be daunting to understand whether it is possible to integrate with one of them for a clinical trial. This would be even more troubling if the study had multiple sites and each site used a different EHR.

People have not generally recognized that the EHR industry, as a whole, has moved much closer to adopting standardized integration techniques. This was forced by the HITECH Act, which instituted monetary incentives and penalties around “meaningful use,” including that EHRs have to be able to input and export data in standard formats, such as CCDA. This makes it straightforward to integrate with most modern EHR platforms.

Moreover, the Fast Healthcare Interoperability Resource, or FHIR [a next-generation standard for exchanging information electronically] has been adopted by a coalition of 40 EHR vendors, taking interoperability a step further, making it even more manageable to integrate the EHRs in a meaningful way.

Q: While your company’s appeal is to smaller organizations with limited budgets, needs and infrastructure, how will you retain them as they grow with increased IT needs and more complex trial requirements?

A: We don’t appeal to just smaller organizations. We feel that we appeal to anyone running a clinical trial. However, the smaller organizations with limited budgets are the ones tending to use paper instead of electronic data capture systems today. We just need to show them that using our platform is faster, better and cheaper than doing trials on paper.

We already have clients using our platform all up and down the size and complexity scales. We believe we will have no trouble retaining clients as they create more complex trials and use more of our advanced features for data collection in those trials.

We also intend to offer additional applications on our platform that will retain our EDC customers longer as clients. We will expose our APIs [application programming interfaces, a set of routines, protocols and tools for building software applications] to partner companies so that ultimately we can provide on our platform a one-stop shop for creating, managing, running and then analyzing the data in their clinical trial.

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 23, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »