Facet’s new Strategic Statistical Services group uses statistical principles and methodologies to maximize precision and efficiency in the development of drugs, biologics, medical devices, and combination products. More and more, small organizations are learning the value of statistics to strategically accomplish corporate and development goals more quickly and efficiently. To help our clients leverage every advantage, we now provide the following strategic statistical services:
- Protocol design, development, and review
- Statistical Analysis Plan (SAP) design, development, and review
- Endpoint selection
- Sample size and power calculations
- Statistical representation at FDA meetings
- Innovative trial support (e.g., historical controls, bucket trials, adaptive clinical trial design)
- Trial simulations and probability of success assessments
- Third-party validation of CRO (clinical and nonclinical study results
- Complex data interpretation and report writing
- Data Safety Monitoring Board (DSMB) membership / representation
- Advisory committee statistical representation
- Meta-analyses and data mining
- Statistical support for in- and out-licencing due diligence