CDISC-Compliant Processing, Monitoring, and Submission of Clinical Trial Data

Clinical Data Standards

The submission of clinical study data to regulators is the culmination of research efforts typically representing years of hard work and often millions of dollars.

The Clinical Data Interchange Standards Consortium (CDISC) was created to define an industry standard for clinical data formatting. CDISC-compliant data sets are now the internationally recognized protocol for the processing, monitoring and submission of clinical trial data.

In addition to proper data formatting for submission, converting clinical data from other formats to CDISC enables trial sponsors to more easily interact and comply with global medical research authorities and healthcare providers.

Converting and Submitting Data in the CDISC Standard

It is essential for trial sponsors to partner with an organization with the experience to properly prepare your clinical data for regulatory submission. Cytel experts work closely with your staff to assess clinical information issues from gap analysis through to the regular generation of CDISC-compliant "submission ready" trial results.

Cytel's own Data Migration center, located in Pune, India, provides several CDISC submission and formatting services including:

• Conversion of legacy data to SDTM compliant data sets
• Creation of ADaM (Analysis Dataset Model) data sets for submission
• Integrated databases for safety and efficacy analyses
• Clinical data warehouse design and development

Specific quality assurance services include:

• Assessment of SDTM structure to handle clinical data and metadata
• Utilizing statistically valid sampling, review SDTM content for data and metadata
• Verification of CRF to SDTM mapping
• Standard validation checks

Why trust your clinical data to Cytel?

Cytel's Clinical Research Services is recognized for advancing the cutting edge of trial design approaches and implementation technologies. With over twenty years of pioneering research, clinical methods development and industry consultation, Cytel's statisticians and trial experts have the trial information know-how to best handle your research effort's most important asset.