Biostatistics
Biostatistics is the backbone of robust and well-designed clinical trial.
Inventives Mind Biostatistics & Statistical Programming team provides integrated solutions, by blending the expertise of programming and statistics. Our biostatisticians work with clients globally to determine methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs. Solid statistical data analysis depends on careful planning and a statistician is involved throughout the lifespan of a project.
With the high cost of executing a clinical trial, it is critical to get the analysis right in the beginning without re-working on the original design. Our resources are configured to permit the greatest flexibility and customization for each client including options for dedicated teams, peak demand allocation, and global deployment.
Statistical Services:
- Power and sample size calculations
- Statistical review of protocol and e-CRF
- Statistical sections of the protocol
- Statistical analysis plans
- Randomization schedule
- Independent Randomization Centers (IRC)
- Statistical modeling/Exploratory analysis
- PK/PD Modelling
- Regulatory Consulting and Representation
- DMC Support and Participation
- Acting as Independent Statistical Center
- Production of Interim Analyses
- ISS/ISE Planning, Analyses and e- submission
- Patient Profiles and ad-hoc reports
- Statistical Reports (CSR, Manuscripts, IB)
- Development of CDISC compliant outputs
- TLF creation, In-text table and appendix
