Statistical Programming
At Neuvantics, our statistical programming services are tailored to meet the needs of different clinical study designs. Our experts have proficiency in robust understanding of clinical data and strong analytical skills to modify, analyze, and present clinical trial data as per study requirements. Our programmers use novel data analytic solutions to prepare and present data with the highest data quality standards to support clinical studies from early-phase trials through to regulatory submissions.
Our programming services include CRF review, CRF annotation, develop mapping specifications of SDTM and ADaM datasets, development and validation of SDTM & ADaM datasets, produce Tables, Listings and Figures (TLFs) for CSR and several other clinical milestones like DMC, DSUR, IB, PSUR etc. We also specialize in supporting integrated analysis for ISS/ISE and BIMO. We provide extensive support for global regulatory submissions and support any information requests from the agencies.
- Proficient review of the study Case Report Form (CRF) from the early phase itself to ensure CDISC compliance
- Preparation of Mapping specifications for CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets
- Programming and validation of CDISC SDTM & ADaM datasets
- Creation of high-quality Tables, Listings and Figures (TLFs) for Clinical Study Report (CSR)
- Develop ad hoc reports to support cross-functional departmental requests
- Prepare submission deliverables like annotated CRF, define.xml, reviewer’s guide (SDRG, ADRG and BDRG).
- Preparation of legacy study data to meet FDA-required CDISC SDTM and ADaM standards
- Pinnacle 21 validation and preparation of required documentation (define.xml, Reviewer’s Guides, SDTM-annotated eCRFs)
- Creation of tables, listings, and figures for comprehensive data presentation
- Preparation of reports to support clinical milestones like Data Monitoring Committee (DMC), Development Safety Update Report (DSUR), Data Safety Monitoring Board (DSMB), Investigator Brochure (IB), Orphan Drug Designation (ODD) etc.
- Production of interim, exploratory, and meta-analyses throughout the trial
- Preparation of ADaM datasets and TLFs for integrated summaries (ISS/ISE) and OSI BIMO.
- Extensive support for IND/NDA/BLA regulatory filings with FDA, EMA, MHRA, Health Canada, PMDA, CDSCO