Biostatistics
KnowTechInfo’s experienced Biostatistics team has consistently delivered high quality statistical services for each and every study we have supported. We have extensive experience with studies across all phases of the pre-and post-development life-cycle (Phase I, II, III, post-marketing studies, market access clinical effectiveness studies, proof of concept, and epidemiology studies). Each study will be led by an experienced Biostatistician who will work with the project teams to deliver high quality results. At KnowTechInfo, we tailor the biostatistical services required for the study and can provide any or all of the following services:
Protocol Development
- Optimal study design selection to achieve the goals of the protocol
- Research and selection of appropriate statistical analysis methods
- Sample size calculations, including simulations when required, for optimal study design
- Protocol writing in collaboration with the clinical team
Randomization Schedules
- Traditional and dynamic allocation schemas
- Complex stratified allocations
- Material lists and kit allocations
Statistical Analysis Plans
- Detailed statistical analysis plans that are ICH E9 compliant
- Table, Listing, and Figure Shell delivered with the SAP
Integrated summaries of safety (ISS) and efficacy (ISE)
Quantitative pharmacoepidemiology design and analysis, including patient registries
Statistical report writing
Statistical analysis and support for interim analyses and Data Monitoring Committee (DMC)
- Blinded and unblinded support, with appropriate firewalls to preserve trial integrity
- Full DMC support to include statistician representation, charter preparation, and DMC analyses
Preparation of case report tabulations (CRTs)
Data mining and exploratory analyses
KnowTechInfo Biostatisticians offer additional expertise in the statistical sciences not often found in other service providers. In addition to standard statistical analysis methods applied to clinical research we are skilled in the following areas:
