Fully realizing that different clients require different levels of support, the statistical programming team recommends and delivers tailor made solutions to suit their needs, ranging from reporting and delivering large submission studies, providing insourced consultancy services, engineering CDISC SDTM conversions and successfully overseeing CDISC ADAM implementations.
Our Programmers have extensive experience of multiple reporting environments and client systems that enables them to undertake complex tasks such as ADaM data conversions for different design of research studies, equally our highly qualified Statisticians excel in tasks such as: power and sample size calculation, compiling statistical sections of research protocols and manuscripts, creating tables for manuscripts and 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, carrying out interim analysis and creating mock shells.
VALOS’s statistical programmers, have over more than a dozen years of programming experience to their credit. They have witnessed the industry change dramatically over the years and work towards implementing all the latest advances in technology and data standards to make clinical trials more productive.
We rigorously conduct intricate QC processes to offer to clients’ accurate clinical data. All of our expert statistical programmers possess detailed knowledge of Phase I-IV of drug and device development and show our pedigree during the following statistical programming tasks:
- Statistical Programming in SAS and R languages
- Data analysis, including designing analysis datasets, statistics, interim analysis, customized DSMBs (also posted via secure Web site)
- Reporting of results, production of analysis summaries: production of Tables Listings Figures (TLF) according to Client’s needs
- Exploratory analyses for publications, abstracts and marketing;
- Double independent validation
- CDISC data conversions (SDTM, ADaM)
- Graphical patient profiles
- Collaboration on ad hoc analyses, regulatory interactions, applications (IND) and annual safety report, reconciliation of safety data
- Pharmacokinetics analysis
- Programming support for Data Cleaning and Discrepancy Management
- Creation, validation and auditing of clinical database and data warehouse