Advice and Consultancy Services
- Study design
- Study synopsis and protocol development
- Sample size estimations
- Randomization Plans
- Electronic database development support
- Data Monitoring Committee (DMC) support
- Support for regulatory submission
Analysis and Programming
- Statistical analysis plan development
- Tables, Listings and Figures (TLFs) specification creation
- SDTM and ADaM creation and validation
- Pre-clinical and clinical trials data review and analysis
- Analysis of real-world (observational) data including: electronic records, charts-reviews, surveys responses, and so on
- Programming using Python, SAS, S-Plus/R, Stata, C/C++.
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Data Management
- Translation of business requirements to technical solutions
- Data quality control and normalization
- Data architecture
- Development of bespoke relational databases
- Advice and support for management of existing data sets
- Provision of data driven strategies
- Report generation for non-technical addressees
Data Wrangling
- Data procurement
- Raw data formatting
- Combining data from multiple sources
- Removal of nonsense input data to prevent garbage in, garbage out analysis outcome
Study Reporting
- Clinical study report development support
- Statistical report creation
- Manuscript development and review
- Patients profiles