Biostatistics CRO: A recognized expertise
ATLANSTAT has a highly skilled workforce in the field of biostatistics and is often consulted in international expert committees.
A well-controlled approach (particularly in oncology), governed by the current international recommendations (EMA, ICH, FDA, CDISC), allows the team to take part in all development projects and to support descriptive, parametric or non parametric analyses.
- Drafting of the statistical section of the protocol
- Preparing and participating in DSMBs (Data Safety Monitoring Board) or IDMCs (Independent Data Monitoring Committee)
- Calculating sample size
- Drafting the Statistical Analysis Plan
- Programming and validating analytical derived data (ADaM format possible)
- Programming and validating of TLGs (Tables, Listings and Graphs)
- Statistical report writing
- Supporting and coordinating of Meta-analyzes
- Support for PK / TK analyzes
Statistical analysis is performed with SAS
ATLANSTAT has a standard program library validated for a greater operational responsiveness.