TAKE provides low-cost, exceptional - quality, Statistical Programming support to the world’s Leading Life Sciences companies through a variety of models including On-site, Off-Site, Off Shore, Functional Service Provider (FSP), study-specific or rescue study support, as well as various resourcing solutions across the life sciences domain.
TAKE’s Statistical Programming capabilities provide various services to understand the effect of a test product on safety, efficacy or other points of interest. Our Programming team works closely with our Biostatistics team to carry out planned analyses which include creation and QC of analysis datasets and tables, listings, and figures. Our teams ensure and achieve accurate results within the stipulated timelines. Quality control is achieved for all the analysis datasets, tables, listings, and figures via independent programming according to dataset specifications or the SAP, as appropriate to ensure accurate results are provided to Biostatistics before final statistical review..
Our Clinical Data study team’s leads and program managers have rich and heavy industry experience in leading programming teams of all sizes. We offer a variety of services to help and complement your internal team’s contributions, including:
TAKE’S Statistical & BioStatistical programming services include:
- Statistical input to study design and protocol
- Randomization and sample size calculation
- CRF design review
- Analysis Dataset Creation
- Generation of statistical tables, graphs, data listings, and figures
- Development of statistical analysis plans (SAPs)
- Data derivation and mapping to CDISC standards
- Implementation of CDISC SDTM and ADaM standards
- SAS programming
- Validation/QC/Verification Programming
- PK/PD Support
- Post-Marketing Clinical Data Analysis
- Interim analysis
- Statistical analyses and reports
- eSubmission Support
TAKE’s Statistical & Bio-Statistical programming offerings and capabilities are uniquely positioned to help the Life Sciences global organizations to perform better and achieve the expected outcomes.