Statistical Programming Services

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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.

Our Services

Planning a Study

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

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

Preparing an NDA/sNDA

Integrated ISS/ISE analysis

Conversion of legacy data to CDISC formats

Data harmonization
Post-Approval

Post-Approval

Exploratory and ad-hoc analyses

Publication support
Result

Completed research in a format convenient for you.