Healthcare & Pharma , Industries

Israeli Startup Claims Clinical Trials Breakthrough

Yonalink's EHR-to-EDC Solution Streams 93% of Patient Data With 100% Accuracy
Israeli Startup Claims Clinical Trials Breakthrough
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Clinical trials can take months to complete. Part of the lag time is that the research staff must manually copy data on thousands of volunteers and multiple medical institutions from an electronic healthcare record system, or EHR, to an electronic data capture system, or EDC. Yonalink, an Israeli startup and EHR-to-EDC streaming provider, said it has solved this problem in a pilot project that involved U.S. and Israeli healthcare providers.

Twenty-one U.S. and Israeli medical centers participated in the pilot, which transferred data from 15 patients in an oncology trial and validated the accuracy of the data. All participating medical centers managed to stream 93% of the requested data to Yonalink's EDC. The data was transferred with 100% accuracy, according to the company.

In the real world, an oncology trial typically involves 3,000 patients and 70 medical centers in 20 countries, said Iddo Peleg, CEO and co-founder of Yonalink. A study from Tufts University shows that an average oncology trial generates nearly 3.6 million data points. Managing such a large number of data points is challenging because of disparate EHR systems in healthcare centers. So, EHR data needs to be transferred to universally accepted EDC systems. Despite the availability of automated systems, this data transfer was done manually for years, likely due to resistance to change, privacy and security concerns, and interoperability challenges.

"In the EDC, the sponsor representative and all the institutions involved in the clinical trial can see the data in one place. The data is harmonized, and they can verify the data," Peleg said.

This single view of the data shortens the time for source data verification, which is usually takes one week and involves travel to the medical center to verify that the EHR data is accurately captured.

EHR-to-EDC Streaming

Yonalink's EHR-to-EDC streaming platform enables the retrieval of data from any EHR system and the seamless mapping of clinical data to the sponsor's clinical trial database or the EDC, the company said in a statement. Yonalink's proprietary system solves the interoperability challenges that have long plagued the clinical trial industry and led to extended trial times, inaccurate data, increased costs and staff burnout.

A Yonalink blog post says EHR-to-EDC streaming is an ideal solution because it automates the transfer of patient healthcare information from EHR to the trial sponsor’s EDC, which prevents transcription errors and improves data oversight and speed.

The data used for the pilot included observations, medications/inpatient administration, diagnosis, procedures and pathology. Users can also upload unformatted files, such as X-rays and handwritten notes, to Yonalink's EDC.

Project Shows Results

Yonalink is working with Israel's Sheba Medical Center for a project, Peleg said. "Yonalink has proven to be an invaluable tool for us during clinical trials to streamline the all-too-often tedious process of patient data collection, which can take about three minutes per data point," said Dr. Eytan Ben-Ami, director of the Clinical Research Department at Sheba Medical Center. "The findings from this study make a clear case that manual data transfer is outdated and leads to significant delays during clinical trials. Clinical trial partners must embrace AI to update the entire data collection and streaming process to benefit all invested partners. With reduced manual busywork and fewer errors, hospitals will be able to accommodate more trials, and ultimately, more patients will be able to access the care they need."

Clinical trials are the main driver for innovation in the pharma and biotech industries and have the potential to help millions of patients worldwide, but "the system is currently broken," Peleg said. "By automating the data collection and transfer processes, we are able to significantly cut down the hours needed for data entry and SDV time, leading to a reduction in costs for the sponsor and a reduction of staff burden for the sites - a win-win for everyone involved."

About the Author

Brian Pereira

Brian Pereira

Sr. Director - Editorial, ISMG

Pereira has nearly three decades of journalism experience. He is the former editor of CHIP, InformationWeek and CISO MAG. He has also written for The Times of India and The Indian Express.

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