Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today introduced Rave Targeted SDV, the newest extension to its Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) solution. Rave Targeted SDV provides clinical research sponsors and contract research organizations (CROs) with an auditable and scalable partial source document verification (SDV) solution that supports risk-based site monitoring strategies.
“The robust controls and reporting capabilities that Targeted SDV inherits from Medidata Rave provide our clients with full audit trail and tracking capabilities to support their regulatory compliance and data quality strategies.”
The verification of source documents by study monitors at investigational sites is considered a good clinical practice by regulatory authorities and is extremely important to ensuring data quality in clinical trials. As EDC systems allow for more real-time, remote access to clinical data and data quality metrics at the site level, study designers and managers are exploring the use of risk-based approaches to monitoring that do not compromise data quality, but allow limited monitoring resources to be directed more effectively to where they are most needed and to the most critical review activities.
Targeted SDV extends Medidata Rave's existing SDV capabilities to support these emerging approaches. Providing clinical study teams with an efficient way to design and execute risk-based monitoring plans within a single system - the Rave EDC platform - Targeted SDV can be applied in a scalable fashion across multiple studies with minimal disruption to existing monitoring and data management workflows.
"With Targeted SDV, our clients can configure Medidata Rave to manage their SDV activities using a risk-based site monitoring model. As a result, sponsors and CROs can help monitors focus their attention on critical, risk-driven operations and study procedures," said Patricia Beers-Block, Vice President of Strategic Regulatory Initiatives, Medidata Solutions. "The robust controls and reporting capabilities that Targeted SDV inherits from Medidata Rave provide our clients with full audit trail and tracking capabilities to support their regulatory compliance and data quality strategies."
Rave Targeted SDV leverages a configurable statistical algorithm to assign subjects to preconfigured, site- and study-specific SDV regimens during study conduct. Leveraging Rave's extreme flexibility, advanced reporting and detailed audit trail capabilities, Targeted SDV provides study teams with the ability to achieve specific SDV coverage ratios defined in their data strategies, perform mid-study adjustments based on site quality and evolving requirements throughout the clinical trial, and gain full visibility into current status, plans and modifications for management or audit purposes.
Rave Targeted SDV is offered as an optional module in Medidata Rave 5.6.3. The product will be demonstrated this month in Medidata's booth #1517 at the DIA 46th Annual Conference in Washington, DC.
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