Biostatistics
Reliable and Efficient Performance.
Aqlivia offers biostatistical services in Clinical Trials phases I to IV and Real World Evidence and Outcome Research. These services are provided to the pharmaceutical industry as a part of a clinical study, as a stand-alone or as a consulting service.
Our biostatisticians and SAS® programmers have a broad knowledge of clinical trials across all therapeutic areas from the initial stage, of planning the study design and defining the appropriate statistical methods, to interpretation of study results.
High accurate statistical analysis is a very important factor in all clinical trials, our biostatistics support from the start-up phase of the project will prevent from unexpected bias when analyzing the data collected.
The experience and competences of our biostatisticians allow to provide the most efficient service according to the customer needs and study characteristics, always complying with the regulatory guidelines.
Aqlivia’s Biostatistics Department may support with the services:
• Statistical Consulting
– Study Design
– Input into Study Protocol
– Sample Size Calculation
• Randomization Planning
• Statistical Analysis Plan (including table Shells)
• Analysis Dataset Specifications
• Dealing with Protocol Deviations
• Continuous Data biases identification
• Data Monitoring Boards management and support
• Statistical Evaluation
– Biomarkers / Immunogenicity
– Efficacy / Effectiveness
– Safety and Tolerability
– Patient-Reported Outcomes
• Regulatory Support
•Reporting
– Interpretation and reporting of data for Clinical Study Reports
– Abstract and publication support
Statistical Programming
• SAS® Programming
• Implementation of CDISC SDTM and ADaM standards
• Analysis datasets preparation, tables, listings and graphics
• Data integration
• Quality Control Plan
• Adequate QC level
• Customized solutions
Our adequate biostatistical and flexible support all around the project will support you at collecting, analyzing and interpreting the right data.
