Cloud-based data magnate Medidata ($MDSO) has signed a deal with TransCelerate BioPharma, a consortium of the world's largest drugmakers, to modernize the way the industry conducts clinical trials.
Through the partnership, TransCelerate will use Medidata's metrics and analytics to better understand the benefits of risk-based monitoring, through which sponsors can use real-time safety data to make decisions on clinical trials. TransCelerate plans to suss out source document verification's exact effects on overall data quality, looking to demonstrate the worth of risk-based monitoring and encourage its use across the industry.
That's where Medidata's expertise and breadth of clinical data will come in handy, TransCelerate said, as the company's Medidata Insights offering pools results from more than 7,000 studies conducted by about 120 sponsors.
Like the FDA and the European Medicines Agency, TransCelerate is already on board with adaptive trial monitoring. The idea behind the Medidata collaboration is to pile up analytical evidence to support it, advocating for more in the industry to adopt the technology. In the process, Medidata will get the chance to show off its technology to TransCelerate's big-name membership, which includes GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ), Pfizer ($PFE) and Roche ($RHHBY).
"Risk-based monitoring is clearly the direction for the future," Medidata CEO Glen de Vries said in a statement. "Embracing this methodology and technology to support it will help sponsors and CROs improve project oversight, make smarter trial decisions, gain efficiencies across clinical operations and reduce costs, all while supporting patient safety, data integrity and compliance."
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