TrialRx service analyzes and mitigates disclosure risks
For pharma companies providing clinical trial data that ultimately winds up in the federal government’s clinicaltrials.gov database, there are a variety of rules pertaining to quality of data and disclosure and analysis of results; these become another set of regulations that create risk-management policies by drug sponsors.
Now, Huron Consulting has set up a monitoring service, TrialRx, to address these regulatory risks. According to the company, a database of “the 32 million unique data points available on the [NIH] website” has been leveraged to provide trial registrations and results reporting compliance. Huron clients are using this database to remediate data quality, sponsor listings and harmonize reporting of 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, life sciences director, in a statement. “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, based in Chicago and London, provides a wide range of compliance, auditing and contract-administration services for, among others, the life sciences industry.