Biostatistics

We understand study data, we deliver the right deliverable

In an increasingly regulated environment, biostatisticians play a crucial role in accelerating timelines and improving the quality of submissions. At Pivotal, we pride ourselves in building a biostatistics team with deep regulatory knowledge and specific therapeutic expertise, matching Sponsors’ needs, to provide accuracy, speed and flexibility with study reporting.

Our biostatisticians use the latest technology to help you in the study design, as well as provide regulatory support and effective analysis and reporting. Our rigorous validation and quality control processes will eliminate the need for corrections and ensure accurate reports.

Our biostatistics services

Statistical analysis plans and integrated analysis
SDTM datasets, validation and documentation
ADaM dataset, validation and documentation
Tables, listings and figures
Statistical analysis reports
Data Safety Monitoring Boards

With advanced technology and deep regulatory expertise, our biostatisticians deliver precise analysis and reporting, ensuring the right deliverables and timely and accurate submissions.

16.4y

Average statistician experience

>280

studies with Biostatistics support

Integration with our Danah Platform

Our Solutions for Biotechs

We offer end-to-end clinical development solutions tailored to your needs. Whether you’re preparing for first-in-human or managing a global Phase 3 trial, our agile team delivers expertise, insight, and hands-on support at every stage.

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