Grant Support Services
Translating complex AI/ML biomarker science into compelling, fundable grant applications for academic and clinical researchers.
NIH R01/R21 Support
ActiveEnd-to-end strategic development of Specific Aims, Research Strategy, and Innovation sections. We align your AI/ML biomarker hypotheses with current NIH study section priorities.
Rare Disease Foundation Grants
ActiveTailored grant writing for specific patient advocacy groups and rare disease foundations. We excel at translating complex multi-omic science into compelling patient-impact narratives.
Biostatistical Plan Development
ActiveRigorous statistical methodology sections including sample size justification, power calculations, and advanced ML validation protocols required by stringent review panels.
FDA Biomarker Qualification
ActiveStrategic alignment of early-stage research grants with long-term FDA Biomarker Qualification Program (BQP) requirements, ensuring data collected today supports regulatory submission tomorrow.
Grant-Ready Biostatistics Checklist
NIH study sections penalise vague analytical plans. Our team ensures your proposal meets the highest standards of statistical rigour before submission.
Study Design
- OKClear delineation between discovery and validation cohorts
- OKJustification of multi-omic platform selection (e.g., RNA-seq vs targeted proteomics)
- OKMitigation strategies for batch effects in multi-center retrospective data
Power & Sample Size
- OKSimulation-based power calculations for high-dimensional ML feature selection
- OKFDR (False Discovery Rate) control methodology clearly stated
- OKAttrition rate estimates included for longitudinal endpoints
Analytical Rigour
- OKPre-specified handling of missing data (e.g., multiple imputation)
- OKCross-validation strategy (k-fold, leave-one-out) explicitly detailed
- OKIndependent hold-out test set secured and sequestered
Key Milestones
Platform development, patent activity, STTR submissions, and validation milestones from the source program roadmap.
