As pathology evolves to a more quantitative discipline, the need for supporting biostatistics increases. Tissue-based digital imaging is data intensive and, more importantly, provides data sets that must be integrated with other data-rich molecular analytical platforms such as NGS and proteomics. Building on several of the founder’s background in biostatistics and bioinformatics and our strengths in quantitative image analysis, Flagship has recently expanded by including both in-house capabilities and academic biostatistics partnerships. On staff we have a biostatistician with 23 years of experience in all areas of statistics in pharmaceutical development, with industry leading experience in the following areas:
Pharmacodynamics and Pharmokinetics Statistics Support
- Define/Refine PK/PD section of protocol design, which will influence patient population, etc.
- Define PK/PD endpoints (primary, secondary, exploratory as appropriate) as well as what non PK/PD are interesting for correlation analyses (e.g. efficacy outcomes, demographics, etc.).
- Define sampling scheme needed to characterize each PK/PD endpoints
- Define/Review CRF forms to ensure necessary PK/PD data are captured properly
- Define SAP, analysis data sets, and table, figure, and listings shells for PK/PD data and analyses
- Reconcile PK/PD lab data with CRF data
- Perform data analyses (performed by statistician, pharmacokineticist, translational scientist, etc)
- Write up PK/PD parts of the CSR with all of the various specialists participating to complete their section
Assay Development with Image Analysis
- Cut-point analysis with quantitative pathology
- Sample size calculations and study design
- Single and multivariate data analysis
Medical Device IDE Filing and Companion Diagnostics
- Study design, sample sizing, case reporting, data submission and results calcuation
- Pre-IDE and other FDA meeting support
- Study submission and negotiation