Biostatistics: Planning, Analysis and Reporting

CROS NT’s biostatistics team has a range of experience, from the planning and design of a trial, to reporting and regulatory submission guidance.

It is generally agreed that the best time to involve a biostatistician in a clinical study is at its inception. This allows the biostatistician to support with common biostatistics challenges in clinical research: understanding the study design and making suggestions on hypothesis testing and analysis.

CROS NT has performed statistical analysis and reporting activities for thousands of studies in a variety of therapeutic areas, in all phases of drug development and medical device trials.

Our biostatisticians deliver the following services:

Planning

Study Design and complex study design including Adaptive and Bayesian
Power/sample size calculations
Protocol Writing and Review
CRF Design & Review
Statistical Analysis Plan

Analysis

Production and Validation of Interim Analysis and Reports
Meta-Analysis
Ad hoc analyses
Preparation of Integrated Summaries of Safety & Efficacy

Reporting

Filing and Reporting with Regulatory Bodies (FDA and EMA)
Statistical Analysis Reports including the statistical analysis part of the Clinical Study Report
Centralized Statistical Intelligence to facilitate Risk-Based Monitoring

Adaptive Trial Design in Biostatistics

CROS NT’s biostatistics team has particular expertise in Adaptive Trial Design: a flexible methodology in which modifications are made along the way based on the analysis of collected data in order to reduce timelines and costs.

Our statisticians have applied this methodology to many studies in various therapeutic areas to change treatment allocation ratios, reassess sample size, modify the hypothesis or drop/add treatment arms. We have particular expertise in oncology studies which carry unique characteristics that can benefit from adaptive trial design.