Biostatistics & Data Management
Pharsight offers broad biostatistical expertise to support optimal trial design decisions, build the right dataset to achieve your target product profile, and perform critical analyses and reporting for your submission.
Statistical Plan Development
Dataset Construction
Statistical Analysis
Reporting, Regulatory Support and CDISC
Data Archiving and Real-Time Data Assembly
Statistical Plan Development
- Protocol and CRF development
- Statistical analysis plans to increase probability of success and optimize design of subsequent trials
- Development of randomization schedules (adapting randomization procedures to account for matching schemes, blocking variable, stratification, sequential analysis)
Dataset Construction
Pharsight scientists have expertise in designing and constructing datasets to support population PK/PD, biostatistical and epidemiological modeling strategies:
- Database design and integration (pooling study data from multiple sources, including complex PK/PD data; statistical methods to account for inter-study differences to increase power and confidence in design of subsequent trial)
- SAS and S-PLUS programming
- Modeling and Simulation Analysis Plan (MSAP) development to reduce the time required for analysis by providing a priori sets of rules on model build-up and how missing data will be handled
Statistical Analysis
- General ANOVA modeling (BE assessment, steady-state assessment, dose proportionality, repeated measurements and random effect modeling, power and sample size calculations, statistical outlier tests)
- Generalized mixed-effects models, multiple linear and non-linear regression models, non-parametric tests, pairplot and cluster analysis
- ROC analysis to identify covariate(s) that maximize probability of response
- Survival analysis (Kaplan-Meier, Cox proportional hazard modeling, time-dependent covariates, competing risks)
- Prediction of dichotomous and polytomous outcomes (conditional [matched] and unconditional [unmatched] logistic regression)
- Interim data and/or blinded analyses, including prediction of final study results and extrapolation to optimize next study or phase
- Post-approval statistical evaluations, including sub-group analyses
- Meta-analyses across the multiple phases of the drug development process
- Exploratory PK/PD correlations and clinical outcome (Exposure-Efficacy and Exposure-Safety assessment, EMAX modeling)
Reporting, Regulatory Support and CDISC
- Biostatistical support at regulatory meetings (including addressing clarifications to global regulatory agencies on applicability of study results)
- Data summarization of PK, safety and tolerability (Tables, Figures and Listings)
- Integrated safety (ISS) and efficacy (ISE) summaries
- Interpretation and preparation of safety tables and reports using SAS
- Support for advisory panel and data monitoring committee meetings
- CDISC consulting to comply with clinical data system and e-submission requirements
- Dataset construction (CDISC, study pooling, SAS transport files, eANDA, eCTD), including Define.xml files
- Publication and abstract preparation
Data Archiving and Real-Time Data Assembly
- Services to build and maintain the required database of data and reports for submission, as PK/PD studies are completed. Building the dataset during the study ("real-time data assembly") minimizes delays in analysis, and leads to earlier decisions.
- Pharsight Knowledgebase Server (PKS) functions as the compliant data repository for PK/PD study archiving.