Biometrics & Statistical Programming
Pratico Consulting stands at the intersection of biometrics excellence, advanced statistical programming, and proven experience in numerous organizations—delivering the scientific rigor, operational precision, and technical depth in CDISC Standards, NCI Controlled Terminology, and cross-functional leadership, study team, and external vendor engagement that pharmaceutical and biotechnology teams require to accelerate development with confidence.
Contact us to learn more about Pratico Consulting and how we continue to empower customers with solutions and services.
Services
Consultation
- Evaluating clients' projects to support team needs and achieve their goals.
Analysis & Reporting
- Expertise in clinical pharmacology in the early-phase I-II space, focusing on Oncology, Neuroscience, and Infectious Disease
- Simple to Complex Adaptive Design Studies
- Leadership in eCRF design and alignment with CDISC and NCI Controlled Terminology
- Analysis Plan Review and Approval
- Data Transfer, SDTM/ADAM specification development, TLF Mock Creation, Statistical Programming Analysis, and QC.
- Regulatory Submission Validation and Documentation Efforts
- Cross-Functional, Vendor, and Study Team Engagement
- TLF Publishing
Statistical Computing Environment (SCE)
- Cloud Platform Development Infrastructure
- SAS Life Science Analytic Framework (LSAF) System Administration and Development
- Global Standard SAS Macro Library Planning, Programming, and Automation
- Quality Assurance IQ/OQ/UAT Testing and Documentation
- SOP/WI Drafting, Review, and Approval
- System Administration, User Training, and IT Business Partnering