In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.
|Articles|May 20, 2014
Medidata and TransCelerate BioPharma Join on Risk-Based Monitoring Methodology
Medidata announced that it is partnering with TransCelerate BioPharma
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Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced that it is partnering with TransCelerate BioPharma on a project designed to inform the nonprofit organization’s efforts around risk-based monitoring.
The joint initiative features Medidata's operational data in the Medidata Clinical Cloud™ to provide metrics and analytics around TransCelerate's recommended methodology on RBM and help answer questions posed by the industry regarding the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites. The analysis will more rigorously assess the relative contribution of source document verification (SDV) to overall clinical data quality.
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