Biostatistical Solutions
WorkSure® provides specialized services for regulatory biostatistics and statistical programming facilities in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9 guidelines, for the analysis and generation of datasets, graphs, tables, and clinical trial data for submission to regulatory authorities. Our highly qualified biostatisticians have in-depth scientific knowledge and thus provide thorough planning and support for biostatistical research projects. Our rigorous validation and quality assurance eliminates the need for corrections and ensures accurate reports.
Our biostatisticians and programmers team helps analyze research data using statistical software programming for Interim and Final Analysis like Statistical Analysis Software (SAS) and Statistical Package for the Social Sciences (SPSS). By using the pertinent tools and methods, we demonstrate the efficacy of an investigational product and present the results in the clearest way possible. We conduct clinical and healthcare analytics including data modeling, processing, validation, and visualization.
WorkSure® takes pride in building a biostatisticians team having specific therapeutic expertise, customizing clients’ needs while providing hassle-free, high-quality, accurate, and flexible study reports across all therapeutic areas. Our team has an intimate understanding of time-tested and latest statistical methods to give the client accurate evaluation of scientific data with experienced handling of all phases of drug development and medical device studies.
Expertise in biostatistics extends beyond that of traditional contract research organization services to the specialized areas of adaptive design and clinical trial simulations, sample size calculation, analytical surveillance, statistical review of Case Report Forms (CRFs), clinical study reports (CSRs), Statistical Analysis Plan (SAP) preparations, meta-analyses, pharmacokinetics/ pharmacodynamics analyses, analysis of stability data for drug expiration dating, and exploratory analyses in support of publications and industrial conferences.
Advantages of WorkSure® Biostatistical Solutions :
- Enabling healthcare professionals to make data-driven decisions and provide efficient evidence-based care
- Providing comparative results of different doses of the same or different medicine
- Determining a new drug’s relative potency compared to an existing drug
- Using statistical tools for data analysis to draw conclusions and identify any unexpected data trends
WorkSure® Biostatistical Solutions
- Preparation of SAP
- Sample Size Calculation
- Data Surveillance
- Preparing CDISC Compliant Datasets (SDTM, ADaM)
- Statistical Analysis, Interpretation, and Reporting
- Data Modeling, Processing, Validation, and Visualization
- Data Mining and Market Research
- Descriptive and Inferential Statistics
- Clinical and Healthcare Analytics
- Statistical Review of CRFs, Clinical Study Reports
- Statistical Software Programming for Interim and Final Analysis (SAS, SPSS)