In an increasingly regulated environment, we enhance biostatisticians’ job as they play a crucial role in accelerating timelines and improving the quality of submissions. Our biostatisticians use the latest technology to help you in the study design; they provide regulatory support and effective analysis and reporting. At Pivotal, we pride ourselves in building a biostatisticians team with in-depth regulatory knowledge and specific therapeutic expertise, matching our customers’ needs, to providing accuracy, speed and flexibility with study reporting. Our rigorous validation and quality control processes will eliminate the need for corrections and ensure accurate reports.

Our biostatisticians´ team is seasoned in information technology and pharmaceutical research data analysis. Many hold advanced degrees in maths, science, or computer science.

Our service offerings:

• Statistical analysis plans and integrated analysis
• CDISC dataset productions (SDTM and ADaM) & legacy study iiiconversions
• Tables, listings and figures
• Derived datasets design, development and validations
• Patient profiles
• Statistical analysis reports
• Data safety monitoring boards