Huron Life Sciences Offers Clinical Trial Monitoring Tool

Huron Consulting Group, a business consulting firm has introduced a new product called trialRx for medical device, pharmaceutical and biotechnology companies. The new service is a product of the firm’s Life Sciences division.

The trialRx service is powered by a proprietary data analytics and visualization tool that leverages a database of the 32 million unique data points available on the National Institutes of Health’s (NIH) website, clinicaltrials.gov. According to the company, trialRx provides an “accurate, automated” way to monitor clinical trial registration and results reporting compliance, allowing companies to “develop focused strategies” to more efficiently manage clinical trial disclosure risks.

“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 is designed to help companies understand their overall risk exposure on clinicaltrials.gov for each of their clinical trials.

According to Huron’s officials, the firm’s clients have experienced a reduction in noncompliance 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 clinical trial 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 B.J. 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.”

Huron’s trialRx service is compatible with existing software solutions that automate aspects of the posting of trials to clinicaltrials.gov and can help ensure that those postings are “complete, accurate and timely,” officials noted.

Huron Life Sciences provides a variety of business advisory services to medical technology companies, healthcare providers, academic medical centers and the law firms and investment firms that support these organizations.