Biostatistics
Biostatistics Services
Consultation and Development of Statistical Aspects in Clinical Trial Designs and Protocols
Biometrics provides expert consultation on statistical design, aligning clinical trials with precise methodologies to enhance database design.
Sample Size Calculations
Through biometrics, sample size calculations are meticulously performed, optimizing study accuracy while adhering to resource constraints.
Development of Randomization Schedules and/or Algorithms
Biometrics supports the creation of randomization schedules and algorithms, fostering unbiased and scientifically sound clinical trials.
Development of Statistical Analysis Plans (SAPs)
Biometrics for database design includes detailed SAPs that guide data analysis, ensuring clarity and consistency in statistical methodologies.
Performing Statistical Analyses and Development of Statistical Analysis Reports (SARs)
Biometrics drives statistical analyses, producing SARs that present findings accurately and support informed decision-making.
Tables, Listings, and Figures (TLFs) (Design, Development, and Validation)
Biometrics services include the creation and validation of TLFs, ensuring robust and visually clear representation of clinical trial data.
Consultation and Review of Statistical Aspects in Clinical Study Reports (CSRs) and Manuscripts
Biometrics provides thorough reviews of statistical content in CSRs and manuscripts, upholding accuracy and publication standards.
Development of Customized Products and Deliverables for Data Analysis and Visualization
Biometrics for database design delivers tailored data visualizations and interactive tools, enhancing the usability and interpretation of complex datasets.
Sample Size and Power Calculations
Biometrics ensures precise power calculations, balancing statistical rigor with the practical needs of clinical study designs.
Study Randomization Schemes
Biometrics expertise creates robust randomization schemes, maintaining fairness and reliability throughout the trial process.
Creation of CDISC, SDTM, and ADaM Domains with Full Documentation and Validation
Biometrics integrates CDISC standards into database design, delivering compliant and validated SDTM and ADaM domains for regulatory submissions.
Assisting Risk-Based Monitoring Activities
Biometrics aids in risk-based monitoring by analyzing critical data points, enabling proactive decision-making and trial optimization.