Medidata and TransCelerate BioPharma Inc. Announce Findings of Joint Research Initiative on Clinical Trial Site Monitoring Methods
Published Results Support Recommended Risk-Based Monitoring Methodology
Using robust operational data available through the
“What we learned through our joint research initiative confirms that SDV is not effective at identifying systemic errors or substantially improving the quality of data gathered. These findings support the approach TransCelerate has outlined for high-quality RBM, which we believe will be an effective and efficient methodology for all organizations conducting clinical trials worldwide," said Dalvir Gill, TransCelerate’s CEO.
The analysis, titled “
“We’re excited to share the results of the analysis and thrilled to be working on this important initiative with TransCelerate, an organization that is paving the way for life science companies to modernize and streamline the way clinical trials are conducted and monitored worldwide,” said Glen de Vries, Medidata’s president. “Over the last decade, Medidata has championed embracing a risk-based approach to the monitoring of clinical trial sites and the technology to apply it effectively. Doing so will enable sponsors and their CRO partners to make smarter trial decisions that reduce costs while supporting patient safety, data integrity and compliance.”
In addition to valuable benchmarking data and industry analytics, Medidata’s technology platform offers an easy-to-use, holistic solution to support RBM called
The largest initiative of its kind dedicated to improving drug development, TransCelerate—and member companies comprising most of the world’s leading, global life science R&D organizations—established five initial projects including the RBM initiative. Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a
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