Blitco offers a complete menu of Bio-statistical and programming services. Sponsor companies can choose the services that meet their needs, from assisting with protocol development to statistical analysis and reporting and our biostatisticians are available to help with statistical needs from protocol design to dissemination of results across all therapeutic areas. Supporting aspects of ongoing project to full project execution, our experts will collaborate with the team to provide analysis that gives a solid basis for decision making.
- Protocol development, review SOP Writing and implementation
- Study population
- Randomization
- Statistical consulting
- Phase I – Phase IV Clinical Trials
- Adaptive and Sequential
- Subgroups and outliers using proprietary software and novel statistical method
- Pre-study epidemiology analysis to determine the cost burden of a particular indication
- Economic, behavioral and humanistic endpoint analysis from ongoing studies
- Post-marketing analysis for comparative studies and claims
- Models to support submission for reimbursement
- Design and analyze quality-of-life (QOL), including treatment group comparisons
- Prepare findings for regulatory submission, journal publication and coverage
- Identify public, private and government audiences for outcomes data Develop Statistical Analysis Plan (SAP) and table shells
- Our SAS programmers are SAS certified & highly experienced and have successfully worked on sponsor projects
- Provide clinical and statistical programming support for Phase I to Phase IV clinical studies
- CDISC standards – SDTM and ADaM implementation and programming as a part of regulatory submissions
- Create programming specifications for SDTM and ADaM datasets
- Programming and validate SDTM and ADaM datasets, tables, listings and figures
- Comply with Company SOPs and ensure programming documentation is completed according to SOPs