Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Clinical and diagnostic study teams |
| Work | Sample-size planning, statistical analysis plans and reporting |
| Rules and standards | Study protocol and intended submission requirements |
Biostatistics in clinical research
Biostatistics support includes the following planning and analysis activities:
● Design clinical study protocols, including statistical input
● Sample size calculation
● Create Statistical Analysis Plan (SAP)
● Develop analytical datasets, as well as tables, figures, and list templates (TFLs)
● Generate random diagrams
● Create drug labeling lists
● Statistical SAS programming
● Central data monitoring throughout the study
● Statistical data analysis
● Prepare mid-year and end-of-year statistical reports
● Analysis after the lesson
● CDISC mapping and transformation
Service information adapted from the original source ↗.
Read the original website record