STATISTICAL PROGRAMMING
Our Statistical Programming Includes
Our proficient team of Statistical Programmers work closely with our experienced biostatisticians in the creation and validation of best programming framework with set of well-defined macros and best practices, which is flexible to adapt to customer’s requirements in clinical studies from pre-clinical to post market analysis. This framework combined with our Quality processes defines the “Programming Platform”.
Biostats IT Solutions programmers have built a reputation of excellence by producing quality deliverables, as we have years of SAS®, R, WinNONLin, Data Visualization Programming skills, combined with in-depth knowledge of specific clinical subject matter.
Services
- Study Datasets development - Ex. SDTM.
- Analysis Datasets Development - Ex. ADaM.
- Legacy Data convesion as per Regulatory Norms ( Ex. SDTM Mapping)
- Development of Regulatory submission packages Ex: Reviewer’s guide,Define.xml, etc...
- Developing TLFs (Tables, Listings and Figures)
- Study Analysis and Reporting
- Publications
- eCTD Submission & post Regulatory Queries Support
We achieve the better services by abiding to the below Processes:
- Annotated table shells
- Independent Validation
- Code reviews
- Centralized status tracking
- Strict adherence to SOPs
- Automates the standardized QA/ QC processes