Data Standardization

Data Standardization

We conduct clinical trial data standardization adhering to CDISC standards or specifications defined by sponsors. Our metadata-centric approach to standardization ensures that our clients receive high-quality results swiftly, accompanied by notable cost efficiencies.

We specialize in transforming diverse clinical trial data into standardized CDISC Study Data Tabulation Model (SDTM) format. This ensures consistency and compatibility, simplifying data aggregation and analysis across trials.

Our team meticulously annotates Case Report Forms (CRFs) with SDTM domains and their associated variables. This process enhances data harmonization, allowing for clear mapping between source data and SDTM domains.

We excel in generating analysis-ready datasets adhering to CDISC Analysis Data Model (ADaM) specifications. These datasets are optimized for statistical analysis, providing a structured foundation for generating insights.

Our services include the creation of Define.xml files, essential for electronic regulatory submissions. These files offer a comprehensive metadata description of the datasets, ensuring compliance and facilitating efficient review by regulatory authorities.

We develop thorough and user-friendly Study Data Reviewer’s Guides (SDRG) and Analysis Data Reviewer’s Guides (ADRG). These guides serve as essential references for reviewers, enhancing the clarity and interpretation of study data during regulatory submissions and audits.

Each of these services contributes to enhancing the efficiency, accuracy, and compliance of clinical trial data management, facilitating smoother regulatory processes and informed decision-making.

Clinical Data Management

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