Stat One, LLC offers SAS and R programming services in support of FDA and EMA submissions. Our focus is on creating high quality output as efficiently as possible. Stat One statisticians and programmers work closely with clients to make sure the content of all statistical packages meets their needs as well as those of regulatory bodies.
Our experience includes:
- Production Programming of tables, listings, and figures
- Validation of statistical output
- Patient Profiles
- RTF output suitable for cut-and-pasting into study reports
- Analysis Dataset creation using ADaM structures
- SDTM conversion (Mapping to CDISC)
- Creation of patient profiles for subject-level review and reporting
- Integrated summaries of safety and efficacy (ISS/ISE)
- DMC Reporting
- Annual Reports for Device Studies
- Ad Hoc Analysis
Stat One, LLC uses their own proprietary TPM System to track all programming and quality control activities.