Our Biometrics team consists of eCRF Managers, Statistical Programmers and Biostatisticians who provide various services over the course of your study.
Prior to study start, our Biostatisticians give input to the study design, objectives and endpoints and perform sample size calculations. They write or review the statistical sections of the study protocol with the aim of optimising the study output. Read more about our biostatistical services.
Our eCRF Managers create a fit-for-purpose eCRF that reflects the study protocol and that allows for collection of all necessary study data. Read more about our eCRF and data management services.
During the study, our eCRF Designers and Statistical Programmers cover all aspects of Data Management- from centralised monitoring support to database-lock and associated clean file documentation. Read more about our statistical programming services.
After the study, our Statistical Programmers will display the data in tables, figures and listings based on the statistical analysis plan (SAP) while our Biostatisticians and Pharmacokineticists take part in data analysis and writing of clinical study reports. Read more about our pharmacokinetic services.
We validate clinical study data by using Pinnacle 21 Enterprise. The tool verifies that data packages comply with CDISC standards (SDTM, ADaM and SEND), controlled terminology, and dictionaries like MedDRA and WHODrug.
Eva Jacobsson, Director Biometrics