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.
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)
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.