CDISC Standards

• Standardized eCRF and SDTM Datasets: Develop standardized eCRFs and datasets in line with regulatory and CDISC (CDASH and SDTM) for consistent data collection, organization and formatting in tabular form, aiding analysis and regulatory submissions.

• Standard Configuration Establishment: Establish standard configurations including edit checks, dynamic rules, and calculations for efficient study design and configuration.

• Enforcement of Standards: Enforce clinical study build standards through the development of implementation guidelines and training, along with processes for ongoing maintenance and updates.

• Automated Standard Adherence Checks: Incorporate automated checks and reports to monitor and ensure adherence to standards at the study level.

• Metadata Repository (MDR) Support: Assist in the creation and maintenance of a Metadata Repository (MDR) for CDISC standards, aiding in consistent data standardization and management.

As experts in CDISC Standards and Standard Global Library (GLIB) builds, we assist our partners in either creating a new GLIB or refining their existing standard library to support their clinical study builds.

The services we offer include: