Medidata and TransCelerate BioPharma Join on Risk-Based Monitoring Methodology

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.