Biostatistics & Statistical Programming
At Neuvantics, our biostatistics services are designed to support and enhance every stage of your clinical research journey. We provide comprehensive statistical expertise to help design, analyze, and interpret clinical trial data, ensuring robust and reliable results that meet regulatory standards. Our team of experienced biostatisticians work closely with clients to tailor solutions specific to the unique needs of each study, from early-phase trials through to regulatory submissions.
Our biostatistics services include study design and statistical analysis plans (SAP), where we collaborate with sponsor to define appropriate methodologies, determine sample size calculations, and develop strategies to optimize study outcomes. We specialize in advanced statistical techniques such as hypothesis testing, survival analysis, regression models, and longitudinal data analysis, which are integral to assessing treatment efficacy, safety, and overall study results.
Neuvantics also provides interim analysis support, allowing for ongoing evaluation of clinical data, helping sponsors make timely decisions during the trial. We assist in the development of comprehensive data reporting, ensuring clear and accurate presentation of statistical findings in clinical study reports (CSRs), publications, and regulatory submissions. Additionally, our services encompass the management and analysis of clinical trial data, ensuring the application of proper statistical methods, adherence to industry standards like CDISC, and compliance with relevant regulatory guidelines such as FDA, EMA, and ICH E9.
Out Biostatistics services include:
- Provide statistical input for clinical trial designs, including adaptive models
- Sample size determination and statistical power analysis
- Preparation and evaluation of Statistical Analysis Plan (SAP)
- Generation of randomization schedules and secure management of treatment blinding
- Statistical programming and validation to ensure accurate data analysis
- Preparation of legacy study data to meet FDA-required CDISC SDTM and ADaM standards
- Pinnacle 21 validation and preparation of required documentation (define.xml, Reviewer’s Guides, SDTM-annotated eCRFs)
- Creation of tables, listings, and figures for comprehensive data presentation
- Support for Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) with statistical insights
- Production of interim, exploratory, and meta-analyses throughout the trial
- Preparation and review of statistical reports and integrated summaries (ISS/ISE)
- Preparation of materials and reports for annual IND submissions and safety reviews