PALO ALTO, Calif., Oct. 30, 2018 /PRNewswire/ -- Verantos, the market leader in regulatory-grade electronic health record (EHR)-based studies, today announced commercial availability of its turnkey solution for real-world-evidence (RWE) study implementation. With the help of Verantos, biotechnology and pharmaceutical firms can run highly accurate observational studies appropriate for regulatory and reimbursement support.
Verantos, the only RWE firm providing regulatory-grade EHR-based study technology, designed a framework to leverage both structured and unstructured EHR data for optimal clinical insight. The firm uses artificial intelligence (AI), including natural language processing and machine learning, to generate highly accurate RWE. This enables Verantos to run studies on difficult inclusion criteria, exposures, and outcomes that would otherwise be inaccurate or impossible. The turnkey solution provided to biopharmaceutical clients includes study protocol, data licensing, technology implementation, independent cohort validation, study completion, and publication of regulatory-grade observational studies.
"The key to EHR-based study validity is sufficient data accuracy and generalizability to support the clinical assertion," said Dan Riskin, MD, MBA, Founder and CEO of Verantos. "Verantos technology leverages rich data sources, enhances cohort accuracy, and ensures demonstrable study accuracy. We see a growing market demand for regulatory-grade studies based on regulatory agencies and health plans increasingly expecting proof of data validity in EHR-based studies."
Based on the 21st Century Cures Act, the Food and Drug Administration (FDA) is expected to release guidance on RWE use in drugs and biologics by December 2018. Early discussions focus on data validity to support accurate clinical assertions. The Verantos solution reduces regulatory risk by addressing common pitfalls of traditional technologies and structured EHR data, such as low accuracy and poor generalizability.
Dr. Riskin, an expert in healthcare AI and successful serial entrepreneur, testified before Congress in 2014 on the 21st Century Cures Initiative. With financial support of the National Institutes of Health and the National Science Foundation, Dr. Riskin's team built advanced technology solutions to run regulatory-grade observational studies from EHR data within the incubation firm VMT. After early success within the biopharmaceutical field, Dr. Riskin launched Verantos to deliver differentiated RWE solutions that improve the marketing and safety of therapeutics. To learn more about Verantos, visit https://verantos.com.
Verantos is the market leader in electronic health record (EHR)-based studies for regulatory and reimbursement use. The company delivers turnkey regulatory-grade real world evidence studies for top biopharmaceutical firms. Advanced data sources and artificial intelligence approaches enable studies that would otherwise be inaccurate or not possible using traditional data sources and approaches. Achieving credible real world evidence studies lowers cost and risk in label expansion, post-marketing surveillance, and reimbursement.
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