Modern Clinical Research

Modern Clinical Development

 

Pharamcometrics and Biostatistics

 

Pharmacometrics and predictive modelling, when incorporated before and during your clinical development, can remove inneffective dosing, reduce subject numbers study timelines and development costs.

 

Biostatistics plays a key role in the planning and preparation of any clinical study. Poor statistical planning can result in excesses of cost and time due to studies being underpowered or over-powered relative to the real risk. As such statistical support for clinical study design is aimed at designing a cost-effective, optimal study design, providing the relevant power and sample size calculation. With many years experience in statistical supervision of Phase I-IV clinical studies to deliver improved data quality and reporting, our statistical services include:

 

  • Support with a clinical study design, choice of endpoint(s) or sample size.
  • Pragmatic model based drug development strategies and efficient trial design through the appropriate use of PK/PD modelling & simulation.
  • Validation of Listings, Tables, and Figures Utilizing CDISC Standards
  • Development and implementation of data, statistical & reporting standards
  • Consultation and interpretation of additional analyses for publications, regulatory requests (including Client Representation at Regulatory Agency Meetings) and other communications
  • Excellent programming skills, in particular R/S+, NONMEM and SAS
  • Adaptive Trial Design & Statistical Modelling
  • Randomization Schedule Preparation
  • Preparation of Statistical Analysis Plans
  • Interim Analysis Planning

 

By providing experienced biostatisticians, Armstrong Clinical empowers clinical research with more efficient pathways to product approval.

 

 

2016 Armstrong Clinical Pty. Ltd.