Our team can advise on a wide range of trial designs helping the sponsor to translate hypotheses into feasible study protocols compliant with regulatory expectations and guidance. Our experience include the design and implementation of equivalence/non-inferiority trials and the development of sequential and adaptive designs, sample-size calculations and simulations to document the statistical properties of complex adaptive designs.
Statistical Analysis plan
The analysis plan covers population/dataset definition, missing values management, primary and secondary hypotheses description, statistical tests, associated assumptions and algorithms used. Furthermore an appendix to the plan contains shell tables/graphics and listings which will be included in the report.
Programming procedures and Computer Aided Report Delivery System
Our Computer Aided Report Delivery System is a group of methods, standard SAS® macros and programs which permit us to generate from our statistical analysis software SAS®, document elements (tables, figures and listings) to be included in text processors or professional publishing tools without additional manipulation or formatting.
This approach permits us to program in advance components of ICH E3 reports or integrated summaries (Summary of Clinical Efficacy – CTD section 2.7.3, and Summary of Clinical Safety – CTD section 2.7.4, formerly ISE and ISS).
Domains of expertise
With over 10 years of experience our team of biostatisticians have acquired expertise in the following fields:
- Sample size calculation
- Equivalence, non-inferiority trials
- Sequential trial design
- Adaptive designs
- Sample size re-estimation
- Dose effect trials
- Phase II/III combination trials
- Trial simulation
- Missing data
- Subgroup analyses