A successful product submission package requires robust, high-quality data. We incorporate quality control checks throughout all stages of programming and analysis. At PharmaProSource®, all statistical programs are subjected to a rigorous quality assurance process, all documents go through a thorough internal review prior to delivery, and all statistical outputs are independently programmed.
We provide submission-ready tables, listings, graphs and figures (TLGF). We help you determine the best format for your project’s data and even convert legacy data to current standards. We also provide statistical programming support for Data Safety Monitoring Committee (DSMC) reports. Using state-of-the-art database analysis tools, we ensure that your data are accurately analyzed and presented in CDISC-compliant format required for regulatory submissions.
Programming Services Include:
· Customized SAS macro generation
· Analysis dataset generation
· Statistical generation of TLGF
· Conversion of clinical study datasets to conform with CDISC SDTM standards
· Programming for drug and disease coding (MedDRA and WHO Drug)
· Programming for import/export of study data