Genelife Clinical Research, boasts a Statistical Analysis department that excels in every aspect of statistical planning, execution, and reporting. With seasoned biostatisticians at the helm, Genelife ensures the robustness of clinical trial data through its exceptional statistical services.
The biostatisticians at Genelife Clinical Research are not merely experts; they are connoisseurs of clinical data analysis. Proficient in the principles outlined in the International Council for Harmonisation (ICH) E9 guidelines, they navigate the intricate landscape of statistical analysis and reporting with finesse. Genelife’s statistical services encompass the full spectrum of clinical trials, from the inception of the Statistical Analysis Plan (SAP) to the delivery of final analysis reports.
In the world of clinical trials, randomization plays a pivotal role in ensuring the integrity of study results. Genelife Clinical Research has devised a state-of-the-art computerized central randomization system, fully validated, and compliant with the rigorous 21 CFR, Part 11 standards. This centralized system guarantees rapid, secure access to randomization procedures, available 24/7 online for investigators to generate randomization codes.
Genelife’s statistical journey commences with the creation of the SAP, a blueprint that outlines the statistical aspects of clinical trials. This includes the development of the study’s design, sample size calculations, and formulation of the statistical analysis section within the protocols. Every facet of SAP writing is undertaken with precision, setting the stage for comprehensive data analysis.
Service Spectrum: From Protocols to Reports
Genelife Clinical Research’s Statistical Analysis department offers a wide array of services, including:
- Protocol Statistical Aspects: This encompasses developing the study design, calculating sample sizes, and crafting the statistical analysis section within clinical trial protocols.
- Patient Randomization and Blinding Plan: Genelife oversees the coordination of patient randomization, a critical element of clinical trials.
- Statistical Analysis Plan: Genelife’s experts formulate the Statistical Analysis Plan for individual studies, outlining the approach to data analysis.
- Data Listings and Tabulations: The department generates comprehensive data listings and tabulations, covering demographic, efficacy, and safety data.
- Tables and Graphics Design: Genelife’s statisticians create tables and graphics that facilitate a clearer understanding of the data.
- Statistical Analysis, Reports, and Synopsis: From conducting the statistical analysis to producing the final reports and synopsis, Genelife Clinical Research ensures that the clinical trial data is transformed into meaningful insights.
Genelife Clinical Research’s Statistical Analysis department is a testament to excellence in statistical planning and data analysis. Their meticulous approach, adherence to regulatory standards, and expertise in statistical analysis offer invaluable support to clinical trials. Genelife’s statisticians are more than analysts; they are interpreters who unlock the potential of data, turning it into the foundation for informed decisions and advancements in healthcare.