Biostatistics - Quantifying Certainty.
Biostatistics being the heart of a clinical trial, we have a team of biostatisticians with over 15 years of experience with marketed therapeutics with NDA/BLA/PMA submissions and interactions with the FDA/EMEA and PMDA. Our team provides consulting solutions on complex statistical issues encountered during study design or analysis.
Our statisticians can lend you a hand in:
- Trial Design – Bayesian and Group Sequential
- Protocol Development
- Statistical Analysis Plan Development
- PK/PD Modelling
- Provide input to: Abstracts/Posters/Manuscripts
- Randomization Services
- Adaptive Design Analysis
- CSR support
We deliver excellent statistical consulting on analysis and interpretation of data using the following statistical models:
Our team will produce mock codes for the project statistician to perform important programming for patient listings or case report tabulations.
We can easily incorporate extensions of randomization, such as
Clinical data analysis requires early assessment of PK/PD data variability together with safety or efficacy data. Strategic drug development planning and smart pharmacokinetic research design can accelerate safety and efficacy.
We deliver high quality PK reports, along with additional PK/PD services, including:
- Input to protocol, trial design and study design including sample size estimation and optimization of PK sampling.
- PK/PD analyses using various graphical and statistical approaches.
- Compartmental and Non-compartmental PK modelling.
- PK/PD linear and non-linear mixed modeling techniques.
- Statistical analyses including bioequivalence, bioavailability, drug-drug interactions, dose-proportionality and special populations.
- Reporting of PK/PD analysis in accordance with guidelines. Fast turnaround interim PK analyses if needed.
- Input into Clinical Study Reports.
Statistical inputs to Protocol
Medical and Biostatistical input to a protocol is critical to ensure the statistical criteria are well defined for study conduct.
At Genpro we:
- Discuss with our partner, the interim adaptation options including sample size re-estimation, and enrichment methods
- Develop a simulation plan for further evaluating the operating characteristics of the proposed adaptive design including power and
- Formulate study design options and run study simulations using proprietary software to evaluate and compare trial operating characteristics
- Consider choices of input parameters such as hazard rates of interest (e.g., Survival, response rate) and expected differences
Once the protocol is approved during the course of the study, our statisticians will provide additional input to ensure the study is being conducted carefully.
Below are the key areas in which statistical input becomes critical and essential:
- Minimizing bias: Randomization and blinding
- Defining desired population sets
- Detailed statistical methodology for efficacy and safety endpoints
- Hypothesis testing: describing/defining the hypotheses, significance level and analysis models
- Handling missing observations.
- Defining deviations from trial conduct
- Approximate time for interim analysis
Bayesian Adaptive Design Analysis
Bayesian adaptive designs are important to today’s development strategies, for high quality results and reduced patient risks along with the ability to work with small samples.