High-integrity data is critical to the safety and efficacy evaluations that are performed in clinical research. From ad hoc project requests to solutions for comprehensive development programs, our statistics/biostatistics experts are here to support you every step of the way.
Since our inception, we have supported our clients by designing more efficient research, revealing more powerful underlying stories from data, and enabling comprehensive, on-time regulatory filings.
Here’s a sampling of our Biostatistics and Programming Solutions:
- Program and study design, planning and consultation
- Interim, adaptive and final analyses for individual studies
- Meta-analysis of study and adjudicated data
- Impartial mock review and pressure testing for filings (NDAs, sNDAs, etc.)
- Statistical Analysis Plans (SAPs)
- Advisory committee planning, preparation and representation
- Statistical programming solutions (SAS®, JMP®, East and many others)