Statistical Programming and Review
- Statistical programmers at M22 Pharma support the development of new medicines by harnessing data from clinical trials into knowledge and produce outputs which display the nature of the data.
- Programmers review Case Report Forms (CRFs), database structures where the data will be stored and lead the production of the Electronic Common Technical Document (eCTD) module 5 during data submission.
SAS Programming
- The Clinical data Interchange Standards Consortium (CDISC) deal with medical research data associated with health care wherein the standards support medical and biopharmaceutical research by ensuring transparency stemming from protocol through analysis.
- At M22 Pharma we ensure our datasets are CDISC compliant. That is, our programmers create standard datasets and supporting metadata such as Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) in line with CDISC.
- The SDTM Implementation guide (SDTM-IG) provides predefined and standardized collection of domains for clinical data submission. Every domain is based on the structure and metadata defined with respect to SDTM. Typically, the data in this domain are raw data which need some modification before the data are analysis-ready.
- Based on the ADaM Implementation guide (ADaM-IG), ADaM provides standards for the creation of an analysis-ready data using SDTM data as the source.
- Once the datasets are analysis-ready, Tables, Listings and Figures (TLFs) are then generated. The Quality Control (QA) and Quality Assurance (QA) team ensure these TFLs are compliant with the study protocol, SAP and
- For every electronic submission, Define-XML (Case Report Tabulation Data Definition Specification) is generated to provide information about which datasets, variables, controlled terms and other specified metadata were used. Summarily, this is achieved by assembling XPT files from various SDTM/ADaM domains, annotated CRFs and SDTM/ADaM specifications.
- Programmers regularly provide the team with trainings on updates to CDISC standards and requirements, macro development and utility programs especially visualization tools.
