Quartesian’s Biostatistics team has extensive experience in Sample Size Calculations, Statistical Sections of the Protocol, Randomization Schedules, Statistical Analysis Plans, PK and PK/PD Analyses and analysis of cardiac safety data (data from pilot and thorough QTc studies).
Sample Size Calculation
Correct sample size determination can be a critical factor in the success of a clinical study and can be the most difficult one. Our statisticians have extensive experience in calculating the sample sizes for numerous preclinical, Phase I-III clinical studies and post-marketing observational/registry studies. With the caveat that all required information is supplied we have the capacity to produce these calculations quickly.
Statistical Sections of the Protocol
Our statisticians have much experience in constructing the statistical sections of preclinical, Phase I-III, and observational/registry studies in compliance with regulatory requirements and ICH recommendations for statistical principals and reporting. Our statisticians can either collaborate with your statisticians or act as your fully-functional statistical team Our statisticians have written these sections for over 250 protocols over the last 10 years.
Quartesian provides patient or volunteer randomization services using proprietary packages that have been validated and have the flexibility to handle almost all variations in study design. The finalized randomization schema provided in either standard or custom formats that will meet sponsor requirements. Quartesian can provide traditional phone- based randomization services, as well as state-of-the-art secure, web-based products. Our advanced software and strict adherence to our SOPs ensures maintenance of “blinds” (where appropriate), confidentiality, and security.
Our global configuration helps us in providing high quality service very cost effectively.
Statistical Analysis Plan
Our statisticians are highly experienced in writing statistical analysis plans for phase I-III, observational/registry and health economic studies. The SAPs are written per ICH, GCP, and FDA guidelines. Our experienced, flexible and responsive biometrics team is known to be expert in preparing SAPs and mock tables, listings and figures in a very timely fashion
PK/PD Data Analysis
Quartesian has extensive experience with analyzing PK and PK/PD data and interpreting the results. We augment our mathematical and scientific expertise with the highest quality report writing which can usually fit seamlessly into overall CSRs or other regulatory documents.
Pharmacokinetic analyses performed by our highly experienced pharmacokineticists are conducted in a fully validated computing environment with proprietary validated and customized SAS Macro programs. The results are validated using Pharsight WinNonlin 5.3.
Our experience and services include:
- Standard PK and PK/PD analysis of data using SAS and/or WinNonlin v5.3
- Population PK
- Integrated Clinical/PK/PD study reports or standalone PK/PD reports
- Preclinical ADME and human studies analysis and reporting
- PK data reported in compliance with CDISC standards
Quartesian has vast experience in analysis of cardiac safety data including QTc. Our statisticians perform the required statistical analysis in accordance with the ICH E14 guidance. We will present your data and results of the QTc analysis effectively and in a timely manner both as a ‘stand-alone’ report and incorporated in the integrated study report, as required. These reports are written by our professional, full time, in-house medical writers.