Accelerate your SDTM Mapping with Pinnacle 21 Enterprise Plus

Mapping source data to SDTM (Study Data Tabulation Model) datasets has traditionally been done using manual methods like:

• Microsoft Excel spreadsheets for mapping specifications, prone to errors and scalability issues.
• Low-code web-based tools that aim to improve efficiency but limit collaboration.

These methods come with significant challenges:

• High potential for manual errors.
• Time-consuming and resource-intensive processes.
• Lack of robust version and change control.
• Increased risk of non-compliance with regulatory standards.

Metadata-driven SDTM programming uses metadata to automate repetitive tasks, significantly reducing manual workload and errors. In the webinar, Senior Product Manager Amy Garrett explained how this modern approach to SDTM mapping has reshaped clinical trial workflows.

Types of clinical trial metadata include:

1. Standardized Specs: Predefined structures containing domains, variables, and mapping definitions.
2. Study Mapping Specs: Reusable mappings tailored to specific studies.
3. Reference Data: Supportive content like lookup tables and validated algorithms.

Amy highlighted several advantages to the metadata-driven approach:

• Faster study start-up by reusing validated metadata.
• More flexibility through standard-level updates and study-specific adjustments.
• Improved data quality using real-time validation.

Senior Customer Success Manager Gilbert Hunter shared how companies are leveraging Pinnacle 21 Enterprise Plus SDTM mapping tool to improve their SDTM mapping processes. P21E’s central metadata repository ensures transparency, consistency, and efficiency:

• Time savings by automating study specification generation.
• Improved quality assurance through early error detection and validation.
• Easier content maintenance with updates to metadata reflected across studies.

Find out how to reduce SDTM mapping timelines and increase workflow efficiency with Pinnacle 21 Enterprise Plus data mapping software.

Alnylam’s story exemplifies the real-world impact of adopting Pinnacle 21’s Clinical Metadata Repository (CMDR). Before implementation, their reliance on spreadsheets led to inefficiencies and risks of non-compliance.

Transitioning to Pinnacle 21 brought:

• Centralized metadata.
• Collaboration across teams.
• Automation of specifications, reducing workloads and ensuring accuracy.
• Early error identification, minimizing pressure as submission deadlines approached.

With P21E, the Alnylam team experienced significant time savings, improved regulatory compliance, and enhanced team collaboration.

Webinar attendees agreed that there is a need for modernization when it comes to SDTM mapping:

• 72% referenced workflow inefficiencies as their biggest challenge with traditional mapping methods.
• 68% agreed metadata reusability across studies is a top priority for their organizations.
• 83% believed automation could reduce SDTM mapping timelines by at least 40%.

Certara’s Pinnacle 21 empowers clinical teams by bridging gaps in collaboration, reducing errors, and accelerating timelines. Every aspect of the platform, from initial metadata setup to real-time validation, is designed to simplify the complexity of SDTM mapping.