Our services
The drug approval process by various regulatory authorities around the world involves significant analysis and data representation of clinical data. These aspects are managed by biostatisticians and statistical programmers along with data scientists.
we are focused on offering these services through the business model suitable to our clients. The business models we are operating includes the staffing as well as project- based consulting models. Our staff is highly experienced in all major therapeutic disciplines and have supported numerous drug submissions for various regulatory authorities around the world.
BIOSTATISTICS
CRF and protocol Reviews
Development of statistical analysis plan
Review of clinical data presentations
Statistical surveillance and monitoring
Pooled data analysis
Statistical report writing
Conducting interim analysis
Data safety reviews
Regulatory submission support
Healthcare and clinical data analysis
Customer trend analysis
Survey design and analysis
Healthcare data modelling
Research design and development of statistical methods
Statistical analysis of out- patient delivery data
Customer retention analysis
STATISTICAL PROGRAMMING AND DATA SCIENCES
Development of statistical mock table presentations
Data transformations and mapping
Production of tables, listings, graphs and profiles
Electronic submission data processes
Risk based monitoring
Edit check programming
Data integrity checks and custom report generation
Clinical data monitoring, reconciliation and integrity checks
Pooled data analysis and tabulations
Data standards Governance and Application
Development of data standards
Application of data standards to healthcare and clinical data
Development of data transformation methods
Validation of transformed data
Application of industry data standards
Data standards compliance required for regulatory submissions
Maintenance of clinical data standards
