CDISC Data Standards

CDISC Data Standards

One of DataCeutics most robust capabilities is in CDISC data standards. Our company possesses a clear-cut advantage with our experience, skills and deep understanding of these standards across therapeutic areas. DataCeutics has been involved with the adoption and implementation of CDISC standards, including CDASH SDTM and ADaM, since the inception of CDISC over ten years ago.

DataCeutics Data Standards Center of Excellence

• Provide internal CDISC training to all DataCeutics staff
• Develop and maintain DataCeutics CDISC best practices and methodology
• Provide expert guidance to all DataCeutics consultants utilizing CDISC standards

At the heart of our Data Standards Center of Excellence are our subject matter experts who have become a proven and valuable resource to our clients. Their deep-rooted understanding of the CDISC standards provides a distinct advantage to our client. Data standard proficiencies and best practices help to ensure that the standard is implemented from the beginning to increase the likelihood of successful submissions.

Services include:

• End-to-end CDISC standard implementation
• Design & mapping for CDASH, STDM and ADaM
• Data conversion for STDM and ADaM
• define.xml and define.pdf generation

DataCeutics has been a SAS® Partner since 1995 and a CDISC member since 2003. Our SAS® programming staff is comprised of SAS® Certified Professionals averaging 17 years industry experience.

• Biostatistics
• SAS® Statistical Programming
• SAS® QC/Verification/Validation
• Protocol Deviation Programming
• SAS® Verification Programming
• Clinical Reporting Tools
• SAS® Systems Development
• Systems Development Life Cycle Methodology
• IEEE Development Methodology
• Standards Implementation
• CDISC CDASH/STDM and ADaM Services
• Electronic Submissions
• Statistical Computing Environment Support
• IT Environment Support
• Clinical Study Report Auditing