Niyantha Technology Solutions
Exciting innovations in data analysis and visualizations are paving the way for a better clinical experience. Our global clinical biostatistics and programming team offers a deep understanding of the science of disease areas and compounds and provides efficient upfront study design and comprehensive planning assistance.
We provide biostatistics and SAS programming services that help you derive meaningful insights from the data and be submission-ready.
We support the entire life-cycle from a statistical perspective, including study design and planning, interim and final analysis, and regulatory submissions.
- Pharmaceutical product development planning, Sample Size estimations, study design, and analysis, as well as supporting methodologies and statistical analysis plans
- Clinical protocol development, Case report form, and Clinical study report review
- Planning and implementing Study final and interim analysis
- Publication support and Ad-hoc analysis
- Support for all phases of clinical trials, from initial dose titration through post-approval services
SAS Programming Services
- Validated Macros bring efficiency, cost savings, and accelerated timelines.
- CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
- Experience with most major EDC platforms
- Derived dataset production and validation
- TLF production and validation
- Regulatory submissions (Development of integrated ADaM datasets for ISS/ISE analyses, Define.XML)
- Submission-ready datasets and programs