Statistical Programming Services

We offer consultant programmers to join and integrate into your existing team under the FSP model. We understand that FSP partnerships require a high level of collaboration, and we are committed to working closely with your team to ensure that we meet your unique needs and objectives.

We are experienced in many therapeutic areas and in every stage of new drug development.

Planning a Study

• Statistical sections for protocols
• Statistical methods consultations
• Simulations to determine and compare performance of various methods
• Sample size calculations

Analyzing a Study

• Outputs for CSRs: Tables/Listings/Figures
• CDISC: SDTM and ADaM data sets, define.xml, reviewers’ guides
• Non-standard method implementation
• Validation of existing outputs, post-text and in-text tables
• PK analysis
• Edit checks and data cleaning

Preparing an NDA/sNDA

• Integrated ISS/ISE analysis
• Conversion of legacy data to CDISC formats
• Data harmonization