Our subject matter experts demonstrate their prowess in this highly challenging field of science and research by working with clients to identify innovative methods to collect, analyze and present data, whilst maintaining compliance with regulatory guidelines.
The work they carry out in this field includes creating customized tables, optimized for uncommon study designs, analyzing solid statistical data based on careful planning and performing data quality checks.
Our experts work closely with VALOS’s team of medical writers to produce easy to understand clinical study reports.
Strongly driven by scientific principles, VALOS’s biostatisticians apply therapeutic indication knowledge to support clients throughout the entire clinical trial lifecycle, through initiatives such as study design, data collection, analysis and reporting.
Whilst working with clients, some of the initiatives undertaken by Biostatisticians at VALOS during their clinical trials process include trial design, power and sample size calculation, collating statistical sections of research protocols and manuscripts, creating tables for manuscripts, data management and analysis.
Their areas of focus include studying design, calculating sample sizes, randomization, putting together well-laid out statistical analysis plans, risk benefit reports, doing interim analysis and creating mock shells, statistical review of protocol, production of randomization schedule, statistical modeling, exploratory analysis, regulatory consultation and representation, production of interim analysis, creating ad-hoc reports and other statistical reports such as CSR, IB and Manuscripts.
The majority of our Biostatisticians have a Ph.D in their field and have been recognized at various international forums. They have also received high praise and recognition from clients primarily in Europe and the US for their work in:
- 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