June 15, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Ready for your DIA Profile of the Day? Today BioSpace talks with Clinovo CEO Glenn Keet about the challenges of integrating electronic medical records and electronic health records systems and what the industry really needs to keep clinical trials running fast and furious. It’s the first of a two-part series with Clinovo. If you’re interested in having your company profiled during DIA, please reach out to our Senior News Editor Riley McDermid.
1. What are the main challenges of integrating EMR/EHR systems with EDC solutions?
The biggest challenge has been the variety of EHR systems in use, combined with the absence of standard way to integrate an EDC system to EHRs. In some worst case scenario, on a very large study with many sites for instance, an integrated solution could mean integrating dozens of different EHR systems with the EDC system.
In cases where there is only a single EHR to integrate with, the integration points can still prove challenging. Most vendors in the industry had historically kept their systems proprietary and closed, making integration difficult and costly. It wasn’t until the HITECH Act and Meaningful Use rules that included interoperability requirements, that EHR vendors started enabling standardized integration capabilities. Typically this was accomplished through importing and exporting data in standardized formats, or less frequently through APIs to call routines.
Users will almost always prefer using a single system to two systems. A challenge is to allow that, either in the EDC system or in the EHR system, with background calls or integration to the other system. But unless EHR integrates data management workflows, users will be forced to continue using 2 systems, even with EDC/EHR integration. The solution lies in how to best integrate data between both systems, in a seamless, cost-efficient manner.
1. How does that change the healthcare landscape?
A significant task in collecting clinical trial data is called “source data verification”, or SDV. Typically, data entered into an EDC system has to be verified against the original source. This is time consuming and expensive. With integrated EDC and EHR systems, the collected data is put into the EDC system, cleaned and verified within the EDC system, then directly copied into the EHR in real time, enabling the data to be considered original in the EDC system and therefore not requiring SDV.
2. What’s special or unique about what you do?
What differentiates Clinovo from other vendors lies in our comprehensive experience integrating our EDC system with complementary eClinical solutions. Some of this work includes integrating our EDC to CTMS systems, risk-based monitoring technology, Medical Coding, Randomization, and CDISC mapping tools. Therefore, we are well positioned to integrate our system with EHRs.
Meanwhile, we are working towards integration being a feature of the platform; in other words, no integration work will be necessary for ClinCapture to work with EHRs. This requires the EHR to be moving towards Meaningful Use to guarantee they can import and export data in standard formats. Moreover, the move towards Fast Healthcare Interoperability Resource (“FHIR”), an emerging HL7 implementation that has been agreed to by at least 40 major EHR vendors, will make this even faster and more robust. Clinovo is well positioned to be among the first to capitalize on this.
BIO: Kleet has worked in health care IT for almost three decades, and since May, 2014 has been CEO of Clinovo, Inc., a vendor of cloud-based EDC software serving all entities running clinical trials. Prior to taking the C-level seat, Keet was senior vice president over Business Development on the Optum Health Care Cloud, focusing on developing the ecosystem of providers, developers and consumers.
Keet became part of Optum via the acquisition of Axolotl Corp., which he co-founded in 1995 and where he was president. Prior to his role as president, Keet had been head of Sales and Marketing, Business Development, and Professional Services. In the first half of the 1990s, Keet held managerial positions for Mercator Software, now owned by IBM . Mercator sold general purpose EDI and HL7 mapping and translation engines used in health care, insurance and other industries.
