Our Statistical and Pharmacokinetics Services provide in-house end-to-end data services using streamlined capture, analysis and reporting pathways.
Our Statistical and Pharmacokinetics Services team offer a range of services related to the regulatory-compliant CDISC model, with a focus on the SDTM and ADaM standards and their supporting documentation.
We ensure full data traceability and track value level metadata so that our supporting Define.xml complies to Pinnacle21 validation and our deliverables are submission-ready for your clinical research trial.
Our Statistical and Pharmacokinetics Services we offer include:
- Optimised study design and protocol review, including sample size calculations
- Statistical Analysis Plan (SAP) development
- Comprehensive suite of randomisation 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
- Seamless integration with Avance Medical Writers
- Embedded quality assurance