Biostatistics: End-To-End Management
Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.
This specialist team provides in-house end-to-end data services using streamlined capture, analysis, and reporting pathways. Their services include a range of offerings related to the regulatory-compliant CDISC model, focusing on the SDTM and ADaM standards and their supporting documentation. They ensure full data traceability and track value-level metadata to ensure our Define.xml complies with Pinnacle21 validation. As a result, our deliverables are submission-ready for your clinical research trial.
Statistical And Pharmacokinetics Services
- Optimized study design and protocol review, including sample size calculations
- Statistical Analysis Plan (SAP) development
- Comprehensive suite of randomization solutions
- CDASH conforming CRF design
- CDISC compliant SDTM and ADaM dataset implementation
- Conversion of legacy data for current submissions
- Complex statistical analysis
- Rapid PK analysis for interim decision making
- Tailored presentation of individual data and aggregated data
- Use of validated specialist software (WinNonlin and SAS)
- Clear and concise communication to all stakeholders
- Embedded quality assurance
Avance Clinical
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