Targeting quality data, delivering focused analysis.

Worldwide Clinical Trials’ clients enjoy access to a full range of statistical services; from consultancy during protocol development, including sample size estimation and review of applicable statistical methodologies, to full engagement in CSRs. Working closely with our clients, we develop a statistical analysis plan (SAP).  The format and structure of all tables, listings and figures (TLF) are pre-specified in TLF shells – so you know how we’ll present your data. Our statisticians are fully engaged throughout the study, working with Data Management performing quality checks of the data throughout its course and collaborating with Medical Writing for the production of the clinical study report, to deliver a seamless process from start to end. All statistical programming and data analysis performed at Worldwide Clinical Trials is governed by a full set of SOPs, ensuring validated quality.  

CDISC

At Worldwide Clinical Trials we deliver datasets in CDISC (including SDTM and ADaM) format, based on extensive experience of the CDISC requirements gained from performing this service across studies and sponsors – including provision of relevant accompanying documentation (including define.xml) and working to the most recent implementation guidelines (currently version 3.1.2). Worldwide Clinical Trials is proud to be a member of the CDISC organisation and all associated programming follows our set of Biostatistics department SOPs ensuring consistency and quality.