Data management processes are executed in a parallel fashion with the Biostatistic activities. Like a symbiotic relationship, data that is captured, cleaned, and verified is then passed on to our Biostatisticians to derive the data sets and produce the analyses that are submitted to the agencies for review.
With the release of the US FDA’s guidance on Standardized Study Data (Dec 2014), CDISC data standards are becoming routine and common place for all phases of clinical drug development and submissions to the FDA.
Study data standards defines a way to present data in a consistent format. Examples of these standards include Study Data Tabulation Model (SDTM) for the tabulation of data and CDISC Analysis Data Model (ADaM) for statistical analysis.
Compliance with CDISC standards at BioPharma will start at data collection. By designing the CRF using CDASH standards, this will allow for the smooth and easy flow of data into SDTM and ADaM datasets.
BioPharma’s suite of biostatistical services include:
Standard CDISC services offered by BioPharma include: