Our subject matter experts showcase their expertise in the intricate realm of science and research by collaborating closely with clients. Together, we identify innovative approaches for data collection, analysis, and presentation, all while upholding strict adherence to regulatory guidelines. This synergy enables us to navigate the complex field of science and research effectively and deliver valuable insights.
In this domain, our experts undertake a range of tasks, including:
- Crafting tailored tables designed to accommodate unique study designs.
- Conducting in-depth statistical analysis grounded in meticulous planning.
- Executing data quality checks to ensure accuracy and reliability.
Our experts collaborate closely with VALOS’s team of medical writers to create clinical study reports that are both comprehensive and easy to comprehend.
Rooted in sound scientific principles, our biostatisticians leverage their therapeutic indication knowledge to assist clients across the entire clinical trial lifecycle. This support encompasses study design, data collection, analysis, and reporting, ensuring a robust and cohesive approach.
As we collaborate with clients, our biostatisticians at VALOS are involved in a range of initiatives throughout the clinical trial process: trial design to ensure well-structured and scientifically sound studies, power and sample size calculations to determine appropriate study sizes, compilation of statistical sections within research protocols and manuscripts, generation of tables for manuscripts, aiding in clear data presentation, data management and analysis to ensure the quality and reliability of the data gathered.
Our biostatisticians at VALOS specialize in various areas, including:
- Statistical consulting: program development plans, statistical evaluation of clinical trial design (analysis strategies, supporting methodologies) according to ICH guidelines and GCP
- Protocol design and review: Clinical Trials (phase I-IV), Simulation and modeling studies, Dose Response Studies, Group Sequential Designs, Adaptive Designs, Diagnostic Studies
- Sample Size calculation
- Case Report Form (CRF) and eCRF Design and Development;Randomization Schedule generation
- Interim Analysis Planning
- Statistical Analysis Plan (SAP)
- Integrated summary for safety and effectiveness (ISS/ISE) according to Sponsor’s requirements
- Collaboration on ad hoc analyses, regulatory interactions, applications (IND) and annual safety
- Statistical reports (including tables, figures and listings)
- Statistical Review of Clinical Study Report
- Publication and abstract support
A significant number of our biostatisticians hold Ph.D. qualifications in their field and have received recognition at international forums. They have also earned praise from clients, primarily in Europe and the United States, for their work in various areas, including statistical consulting, protocol design, sample size calculations, CRF and eCRF design, interim analysis planning, ISS/ISE preparation, ad-hoc analyses, regulatory interactions, and the production of statistical reports, among others.
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