Biostatistics

End-to-end management

Avance Clinical boasts a team of biostatistics and pharmacokinetics experts who 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.

CONTACT OUR IN HOUSE SCIENTIFIC & REGULATORY AFFAIRS TEAM
IN AUSTRALIA, NORTH AMERICA AND EUROPE

Delivering more than 30 years experience of drug development expertise

Statistical and Pharmacokinetics
Services

Our Biostatistics 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

WHY BIOTECHS CHOOSE
AVANCE CLINICAL

More than three decades of deep clinical research management experience, Avance Clinical is the largest
specialist Australian and US CRO delivering quality clinical trials in Australia, New Zealand, Asia and North America for international biotechs.

43.5%

REBATE

5-6 Wks

START-UP TIME

100%

CAPABILITIES

FDA

COMPLIANT RESEARCH