Reporting and Regulatory Submissions

Statistical Programming Services: When you Have a Project that Your Infrastructure Cannot Support

Telperian has expertise in FDA Electronic Submission Guidelines and the CDISC data model that is endorsed by the FDA. We have many years of experience in creating individual study reports or integrated reports such as CSS, CSE or 120 Day Safety Updates for both NDA’s and BLA’s. We can perform any of the following as individual tasks or as a full suite:
· Create individual study or integrated analysis data sets
· Create tables, listings and/or figures for individual or integrated studies or submissions
· Create SDTM data sets
· Create ADaM data sets
· Create define.xml
· Create validation documentation for all programming related tasks
· Adhoc validation of output or programs produced by someone else

Our team is also experienced in developing data set creation and reporting utilities and macros. Developing and implementing standardized utilities and macros can dramatically increase the efficiency of your organization by allowing your resources to focus on the less mundane and more difficult tasks.