Our Biometrics team consist of eCRF Managers, Statistical Programmers, Pharmacokineticists and Biostatisticians and will guide you from study design to report.
Prior to study start, our Biostatisticians assist with selection of endpoints and sample size calculations to ensure that your study meets the target and write, or review, the statistical sections of the study protocol with the aim to optimise the study design.
Our professional eCRF Managers will create a fit-for-purpose eCRF that reflects the study protocol and that allows for collection of reliable data for primary and secondary endpoints. As a flexible and cost-effective partner, we pride ourselves in delivering high-quality data in a timely manner.
During the study, our eCRF Designers and Statistical Programmers work with high efficiency in assignments covering all aspects of Data Management – from eCRF design to database lock and documentation. The Biometrics team also perform randomisations and interim analyses.
After the study, our Statistical Programmers will display the data in tables, figures and listings as outlined in the statistical analysis plan (SAP) while our Biostatisticians and Phamacokineticists take part of the data analysis and clinical study report writing in accordance with agreed timelines. As part of our process you can expect a first debriefing within 48 hours after database lock.
Calle Joachimsson, Director Biometrics