Focused on delivering clear and concise biostatistics and programming expertise to ensure the data analysis of your trial is produced accurately, efficiently and on time.
Our Biostatistics and Clinical Programming Team has extensive industry experience in a variety of therapeutic areas, including extensive interactions with regulatory agencies, development support, strategy planning and expediting the approval process. We add value to study teams by bringing technical expertise to projects of all sizes, from small first-in-human trials to large multinational studies.
‘We add value to study teams bringing technical expertise to projects of all sizes.’
From the inception of a study to final reporting, statistical consultancy is key to a study design fit for purpose that meets all the study objectives and focuses on the endpoints alongside ICH compliance. Our statisticians offer experience in various study designs (including adaptive and Bayesian designs), sample size estimation, handling of missing data and combining trials for ISSs and ISEs. This level of expertise is demonstrated through the development of the Statistical Analysis Plan (SAP) text and TFL shells which will describe the methods to be used to analyze, summarize and present the data. Our statisticians collaborate with medical writers and scientific experts to ensure the appropriate interpretation of study results.