Frontage’s versatile statistical programming services and analysis capabilities support clinical studies or standalone projects. We implement statistical analysis plans, deliver interim and final analyses, or convert legacy data into current FDA-accepted formats.
- Development of SDTM/ADaM using CDISC standards
- Statistical analysis and programming support for data queries, database edit checks and creation of analysis datasets
- Creation of listings, tables and graphs for interim analyses, Data Monitoring Committee support, clinical study reports and integrated summary reports (ISS/ISE)
- Pharmacokinetic and pharmacodynamic data analysis and modeling
- E-submission package
- CDISC implementation (SDTM/ADaM database)
- Annotated CRFs
- SDTM/ADaM Define.pdf or Define.xml
- SDTM/ADaM Reviewer’s Guides
- Legacy data conversion to SDTM
- Analysis and reporting of pre-clinical data
When developing a new drug, statistical programming is essential. Statistical programming services can be used to analyze the safety, efficacy, or other effects of a product. Validated data is then transformed into interpretable information for biostatistical analysis.
Frontage’s clinical services team offers a complete suite of services from study design to delivery of final report. Our biometrics team specializes in providing high quality, comprehensive data management, biostatistics, and SAS programming services.