OUR SERVICES
Statistical Programming
Recognizing that clients have varying support needs, our statistical programming team offers personalized solutions. This spans from generating reports and handling extensive submission studies to delivering insourced consultancy services, orchestrating CDISC SDTM conversions, and effectively managing CDISC ADaM implementations. We tailor our support to align with the unique requirements of each client.
Our programmers bring with them a wealth of experience in handling various reporting environments and client systems, enabling them to tackle intricate tasks like ADaM data conversions for diverse research study designs. Our highly qualified statisticians excel in a wide array of responsibilities, including power and sample size calculations, the compilation of statistical sections within research protocols and manuscripts, crafting tables for manuscripts, as well as managing and analyzing data.
Their expertise extends to study design, sample size calculations, randomization processes, the development of comprehensive statistical analysis plans, the generation of risk-benefit reports, conducting interim analyses, and the creation of mock shells to streamline the research process.
VALOS’ statistical programmers boast a collective experience of over a dozen years in the field. Their extensive tenure has allowed them to witness substantial changes within the industry. Committed to progress, they diligently incorporate the latest technological advancements and adhere to evolving data standards to enhance the efficiency of clinical trials.
Our commitment to providing clients with precise clinical data is unwavering. Each of our expert statistical programmers possesses in-depth knowledge of Phase I-IV drug and device development, showcasing their expertise in a range of statistical programming tasks. These include:
- Statistical Programming in SAS and R languages
- Data analysis, encompassing the creation of analysis datasets, statistical procedures, interim analysis, and customized Data and Safety Monitoring Boards (DSMBs) with secure web posting
- Result reporting, including the production of Tables, Listings, Figures (TLF) tailored to the client’s specifications
- Exploratory analyses for publications, abstracts, and marketing
- Double independent validation to ensure accuracy
- CDISC data conversions for SDTM and ADaM
- Development of graphical patient profiles
- Collaboration on ad hoc analyses, regulatory interactions, IND applications, and annual safety reports, reconciliation of safety data
- Pharmacokinetics analysis
- Programming support for data cleaning and discrepancy management
- Creation, validation, and auditing of clinical databases and data warehouses
Our rigorous quality control processes underpin our commitment to delivering accurate clinical data to our clients.
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