Rave TSDV (Targeted Source Data Verification) is a software solution designed to streamline the process of source data verification in clinical trials. It empowers Clinical Research Associates (CRAs) to adopt a risk-based approach to monitoring by focusing on critical data within Rave EDC (Electronic Data Capture). This targeted approach results in a more efficient and cost-effective monitoring strategy without compromising regulatory compliance or data quality.

Key Features

Risk-Based Approach Rave TSDV enables a targeted SDV strategy focusing on critical data.

• Supports ICH GCP E6 (R2) & E8 (R1) compliance
• Maintains an inspection-ready record of verified and non-verified data

Flexible Configuration The software allows for customized SDV plans at various levels.

• Study-specific and site-specific SDV configuration
• Configurable down to data field, form, and patient visit levels

Integration with Rave EDC Rave TSDV seamlessly integrates with Rave EDC for efficient data management.

• Selects CRF fields for verification during on-site visits
• Enables CRAs to focus on critical-to-quality factors

Benefits

Cost Reduction Rave TSDV significantly reduces monitoring costs and improves efficiency.

• Reduces CRA and site burden
• Decreases data cycle times

Improved SDV Strategies The software enables better planning and execution of SDV strategies.

• Maintains full coverage of critical safety and efficacy data
• Allows for easy design, configuration, and execution of targeted SDV

Enhanced Focus on High-Value Activities Rave TSDV allows monitors to prioritize important tasks.

• More time for targeted communications with sites
• Less time reviewing non-critical data
• Full visibility into SDV assignments, progress, and modifications