We understand that a well-designed and appropriate analyzed clinical trial is fundamental to provide valid results, reduce the risk of compromised timelines and errors, accelerate decision making, and save time to market.
Our biostatistics staff, all with a degree in statistics or biostatistics, has a long experience in study design and statistical analysis in a wide range of statistical methodology required to analyze and interpret simply or complex clinical data sets in a broad range of therapeutic areas. We provide high quality deliverables on every project we manage, fully compliant with regulatory guidelines, within the sponsor’s timelines.
Whether you require a complete full-service or a standalone consulting service of one hour, our biostatistician staff provides solutions to satisfy your needs through quality, expert consultation and services in a timely manner.
- Protocol and case report form review
- Randomization specifications and schedule
- Statistical analysis plans including shells of all planned tables, listing and figures
- SAS programming (single or double)
- Tables, listing and figures generation, audit-ready at delivery
- Writing statistical reports
- Interim and/or exploratory analyses
- Data and safety monitoring board and steering committee support and participation
- Writing and reviewinf study reports, manuscripts, abstracts, and scientific presentations
- Preparing for and participating in meetings with regulatory authorities
- Formulating and defending responses to journal editors and manuscripts reviewers
- Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results.
Our expertise includes:
- Analysis of Variance and Covariance
- Logistic Regression
- Categorical Data Analysis
- General Linear Modeling
- Significance Testing
- Longitudinal Data Analysis
- Survival Analysis
- Joint Models for Multivariate Longitudinal and Multivariate Survival Data
- Sensitivity, Specificity, PPV, NPV and ROC analysis
- Power and Sample Analysis, including Adaptive Trial Design
- Propensity Score Matching Analysis
- Statistical Analyses of Rare Diseases
SPARC’s professionals have a deep experience in clinical trials in the following main therapeutic areas:
- Central Nervous System
- Gastrointestinal and Hepatology
- Infectious Diseases