EHR to EDC Interoperability: Problem Solved

Two cutting-edge software companies have solved the dilemma of retrieving unstructured EHR data and populating EDC with structured clinical trial data.


Crucial Data Solutions, Inc.™ and Zircon Technologies™ announce a strategic partnership that offers an innovative solution to automate manual processes in clinical trials. Designed to accelerate the clinical trials process, Zircon’s on-demand, easy-to-use software, TrialKit AI, pulls unstructured data from any EHR (Electronic Health Record) format or lab data from an existing eSource and populates it via web service in the TrialKit eClinical system. Anirban Gangopadhyay, CEO of Zircon Technologies, explains, “Our API, combined with the TrialKit dynamic web service, is the solution to going one hundred percent paperless for trials. TrialKit AI significantly reduces the burden of data transcription on the clinical site – enabling real-time monitoring and source data verification.” TrialKit AI overcomes the hurdles typically associated with EHR-EDC integration.

Eliminate Repeated Data Entry

Zircon’s web-based application utilizes an EHR-to-EDC API to eliminate a major pain point for clinical research coordinators (CRCs): redundant manual data entry that occurs in the EHR system and once more in the EDC system. TrialKit AI shaves weeks of time off the source data verification process.

Because of the advanced nature of the TrialKit WebAPI, all data submitted from an EHR to TrialKit is subject to normal Case Report Form (CRF) data cleansing. Any anomalies found in the data immediately generate queries, which are sent to the appropriate roles. Cody Wilke, Product Manager for Crucial Data Solutions, had this to say, “We are very pleased with this partnership. It marries two technologies that will greatly streamline the clinical trial process. The connection can be used to detect adverse events in the EHR data and automatically notify the appropriate safety personnel in a trial. It can also be used in early-stage participant screening.”

No Heavy-Weight Integration Involved

Zircon’s lightweight API ingests anonymized clinical notes and data and automatically writes to the appropriate eCRF hosted in TrialKit. There is no need to interface with an EHR system; TrialKit AI simply decodes the data from PDF and CCD files that are exported from an EHR system and then loads and classifies the data in a structured format to be imported into an eCRF. TrialKit’s secure, comprehensive web service is designed to interface with any external platform, making TrialKit’s data population into the trial database incredibly organic and efficient.

Regulatory Compliant Environment

TrialKit AI is a regulatory compliant system, as it meets 21 CFR Part 11 and HIPAA standards. Users can also be assured of the system’s security: data is transmitted to TrialKit through its secure RESTful web service.

Crucial Data Solutions’ TrialKit is also 21 CFR Part 11 and HIPAA compliant, furthering the extent of the security as data is being imported. Wilke elaborates, “Regulatory considerations in TrialKit’s Web API means all transactions, data, and changes are automatically audited. Pulling the data from EHR notes is no different than the site coordinator entering the data or the clinical monitor verifying the data … except the days-long process has now been reduced to minutes.”

No Change to Workflow

TrialKit AI was developed to bring little to no disruption to a research team’s workflow. CRCs simply export PDF files containing data, text notes, and adverse events from an EHR system, and easily anonymize them with the desktop app before uploading to an EDC system. CRCs can then view, edit, verify, and submit the rendered eCRF, thus greatly expediting the data cleaning process. The structure of the TrialKit database optimizes integration into its web service to minimize any need for additional development.

The TrialKit AI application, coupled with the TrialKit eClinical system, lays to rest the notion that utilizing EHR data for EDC is not plausible. Unstructured data from clinical notes can in fact be populated into eCRFs to greatly decrease both cost and time spent on manual data transcription.

Alethea Wieland, Managing Director of SCOPE International USA, Inc., a North American subsidiary of a global contract research organization states, “As a collaborator to both of these innovative technology companies, SCOPE International is encouraged by these advances demonstrated by Crucial Data Solutions and Zircon Technologies. This solution specifically addresses both the vision outlined in the 21st Century Cures Act for EHR-EDC interoperability and the US FDA’s interest in industry working together to fix this problem. It also allows us to finally step through the front door to the next frontier in research where research costs to sponsors can be dramatically reduced, time to market is improved, and patient access to new therapies is faster. This new technological breakthrough is very disruptive in a good way.”

About Crucial Data Solutions

Crucial Data Solutions, Inc. is a forward-thinking company dedicated to developing innovative technologies that reduce the cost of medical research by equipping clinical professionals with the tools they need to advance treatments that enable patients with life-altering conditions to lead better lives. We believe clinical research should be a true partnership between ourselves, research professionals, caregivers, and patients worldwide.

About Zircon Technologies

Zircon Technologies is a technology company that is focused on accelerating clinical trials. Our software works together with the EDC to empower clinical sites to automate manual processes and alleviate painful bottlenecks in recruitment and monitoring. By coupling proprietary NLP and machine learning algorithms with a plug and play integration process, Zircon is able to seamlessly integrate with EHR systems and empower an optimized process for any trial.

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