From study design to protocol synopsis, to conduct and the close-out phase, Excelya produce end-to-end statistical analysis to ensure that your clinical trial defines all information required for authorities and stakeholders.
With a responsibility to ensure the integrity and accuracy of your data, our specialists become a part of your team, providing expertise and knowledge throughout every step of your trials. Excelya biostatistics professionals will help you interpret data, allowing you to gain insights that accelerate decision-making and improve the quality of submissions.
Biostatistics experts connect with every part of a study, and are involved from the project’s inception to its closing phase. Excelya take pride in delivering such an integral part of our clients’ clinical trials, and have been managing the statistics and programming element of some clients’ trials for more than 20 years.
Our statistics and programming experts have many decades of combined experience, across a wealth of therapeutic areas, and ensure that studies are delivered efficiently, accurately and with utmost professionalism.
The 40+ members of our statistics and programming team average 13 years’ experience in defining statistical analysis from the planning phase through to the conduct and close-out phase. With an integrated international team, our statisticians and programmers have experience managing data for clinical studies across all clinical phases and across multiple therapeutic areas. Our harmonised processes and common platforms ensure clinical data consistency across each project.
To successfully manage a statistics project for any study of any phase, an experienced biostatistics team needs to be involved from the early development planning phase, to submission, to post-marketing approval.
Planning Phase
Perhaps the most influential stage of a biostatistician’s involvement in a study, the planning phase of any clinical trial involves mapping out what the study will look like: what data needs to be captured, the calculation of the sample size, power analysis, what the treatment arms will look like, whether or not any adaptive designs may be required, creating a statistical analysis plan – the list goes on. This stage can take some time investment to take shape, but is key to ensure accuracy and efficiency for any clinical trial, as well as optimal benefit for patients.
Conduct Phase
A statistician’s role during the study is to take steps to ensure that study data maintains its integrity. They will attend study team meetings, representing the biometrics function, maintaining a close knit relationship with the Data Management team. They will be involved whether or not the study is blinded or unblinded; often working with independent data review committees (iDMC, DSBM, DRC, etc.) to monitor the safety of the study, or managing an interim analysis, if appropriate. The main objective is to avoid bias from both the patient and the sponsor/study team, so that the patient can relay their symptoms accurately, and the study team will not ask biased questions.
Closing Phase
Often the first team members to see a study’s results, a biostatisticians’ primary role during the closing phase is to provide support to teams and stakeholders, guiding the interpretation of results and deliverables to ensure that all medical conclusions are congruent with the study’s data.
DEDICATED, FULL-TIME 44 MEMBER TEAM
13 YEARS OF EXPERIENCE ON AVERAGE
EXCEPTIONALLY QUALIFIED TEAM MEMBERS
HIGHLY KNOWLEDGEABLE STAFF
Statistical programming allows pharmaceutical, medical device and biotech companies to capitalise on the power of expert knowledge, technology and automation to process trial data into a format that is analysis- and submission-ready.
Effective Statistics departments play a key role in successful clinical trials as they allow sponsors to confidently determine accurate and actionable conclusions from the data collected during the study. The core responsibility of the Statistics team is to support decision-makers with their determinations, by providing deliverables that are free of errors and biases. Their role spans across the trial design process, data monitoring, analyses, closing phase and reporting.
