CTMS takes forefront in Life Sciences

End-to-end Clinical Trial Management Software (CTMS)—long sought as the “holy grail” of fast and successful product development—is streaming into the life sciences marketplace. As the central hub of all information and management in a clinical trial, CTMS offers potential for data sharing, transparent communication, and cost-effective streamlining of clinical development operations. In some vendor offerings, […]

Using SAS “PROC TABULATE” for Clinical Trial Tables and listings

Tables created for clinical studies have certain common features. A sample annotated demographics table (above) with annotated descriptions of the key features. Notes for the table: This is not a simple page counter. It also includes the total number of pages for the given piece of output. In the column heading you see “N=,” which […]

CDISC 101 – A clinical trial data management standards primer

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models. Four of these models are of particular importance:  Study Data Tabulation Model (SDTM). The SDTM defines the data tabulation data sets that are to be sent to the FDA […]