Clinical Data Management

Clinical Data Management (CDM) is a critical component of the drug development process, involving the collection, cleaning, validation, and analysis of clinical trial data to ensure its accuracy, completeness, and integrity. CDM plays a crucial role in supporting regulatory submissions and decision-making by providing high-quality, reliable data for analysis and interpretation.

CDISC (Clinical Data Interchange Standards Consortium) data preparation involves transforming raw clinical trial data into standardized formats that facilitate analysis, exchange, and regulatory submissions. CDISC standards, such as the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM), provide a framework for organizing and standardizing clinical trial data, enhancing interoperability and data transparency. CDISC data preparation ensures consistency and comparability across different studies, enabling efficient data integration, meta-analysis, and cross-study evaluations.

AreteVolo will serve you prepare CDISC SDTM data which are ready to be validated. 

Validation of CDISC data involves conducting thorough checks to verify the accuracy, completeness, and compliance of the data with CDISC standards, as well as with regulatory requirements and sponsor-specific protocols.

Validation efforts are supported by validation plans, standard operating procedures (SOPs), and validation tools and software, which facilitate systematic and comprehensive validation activities.