Biostatistics
TruMinds statistics team has conducted hundreds of trial analyses for many different drug, medical device, and diagnostic products. We have created hundreds of statistical analysis plans and protocols. We began creating adaptive trial designs before the FDA published its guidance on this approach, and we use adaptive designs as often as possible.
Biostatistics Services
- Clinical Trial Design
- Protocol Development
- Sample Size Calculations
- Representation at Regulatory Agency Meetings
- Statistical Regulatory Consulting
- Randomization Schedule Preparation
- Statistical Analysis Plan (SAP) Development
- SAS Programming and Independent Validation of Tables, Listings, and Figures
- Interim Analysis Planning
- Topline Analysis Package
- Final Analysis Package
- DMC Statistics Services
- PK/PD Analysis
- Rescue Study Services
- CDISC Deliverables (SDTM, ADaM, Define)
- CDISC Conversion of Legacy Data
- Integrated Summaries of Safety and Efficacy (ISS/ISE)
- Statistical Reports
- Statistical Review of Clinical Study Report (CSR)
- Manuscript Development
