Consulting Services
Statistical Consulting
Start, manage, and develop the infrastructure of the Biometrics/ Statistical and Data Science team.
Improve data management and statistical analysis processes.
Select, manage, and maintain oversight of CROs.
Participate in the development and design of clinical trials, including clinical endpoints definition, statistical design, methods, analysis, and reports (CSR, ISS, ISE, abstracts, and manuscripts) of Phase 1 through Phase 4 studies.
Provide Design of Experiment (DOE), and statistical analysis in pre-clinical studies and process development setting.
Predictive modeling/machine learning (ML) of clinical trial endpoints using clinical biomarkers and manufacturing variables.
Participate in various communications with regulatory agencies in regards to clinical, non-clinical, and process development topics.