Huron Consulting Group, a Chicago, Ill.-based provider of business consulting services, has launched its trialRx service, a Huron Life Sciences clinical trial data monitoring service to help pharma, biotech and device companies understand and mitigate clinical trial disclosure risks.
Huron Life Sciences’ trialRx service is enabled by a unique, proprietary data analytics and visualization tool that leverages a database of the 32 million unique data points available on the NIH’s web site, clinicaltrials.gov. The trialRx service provides an accurate, automated way to monitor clinical trial registration and results reporting compliance, allowing companies to develop focused strategies to mitigate clinical trial disclosure risks efficiently.
“The trialRx service provides life sciences companies with a straightforward, efficient way to monitor all publicly available information posted on clinicaltrials.gov. Based on this information, they can generate insights to inform and support various clinical operations and compliance initiatives,” said Paul J. Silver, managing director and practice leader, Huron Life Sciences. “We developed the trialRx service to further support the strategic, clinical and regulatory compliance needs of our clients in a world where data is everywhere—and where being able to use it is critical.”
The trialRx service equips companies to understand their overall risk exposure on clinicaltrials.gov for each of their clinical trials. Huron’s clients have experienced a reduction in overall noncompliance and realized additional value by using the service to enhance data quality, create business insights and identify operations improvement opportunities. Specifically, clients have used the trialRx service to identify and remediate data quality issues including errant sponsor listings, duplicate secondary IDs, lack of universal trial numbers and identification of non-harmonized study conditions and interventions.
“Our trialRx service fills a distinct need in the marketplace by closing the loop between what is posted by clinical trial sponsors—either manually or using trial data disclosure solutions—and what regulators require,” said BJ D’Avella, director, Huron Life Sciences. “It provides sponsors an efficient, cost-effective way to understand their evolving clinical trial portfolios and can be customized to meet our clients’ unique business and compliance needs.”