Pharma Data Management
Eurofins Global Central Laboratory has a team of experienced Data Management staff who will design studies based on client needs. The Data Manager dedicated to a assigned study, defines all required laboratory tests, including visit specific information regarding units and flags based on the study specific protocol. Planned visits and tests, reporting parameters, results calculations and study-specific flags are defined by the Data Management team. This is applicable to QC-procedure which comprises of peer review and dummy test runs.
Each study is set-up in the global LIMS (Laboratory Information Management System) at Eurofins Global Central Laboratory. All data is available to each Project Manager at any individual Eurofins Global Central Laboratory location through one global database deployment. This set-up procedure not only allows global standardization, control and centralized priming but also enable fully automated analysis in the laboratory. All studies that are set-up in the global results database are accessible through the Eurofins Medinet Data Portal (EMDP), which is a global data management system. This system provides real-time global reporting of investigator reports, management reports and electronic data transfers. The Electronic data transfers are available in CDISC, ASCII, SAS and XML formats and are performed via specifications from the Sponsor. Prompt regular data checks as well as data cleanings are performed to ensure that all data are correct and precise prior to study closure.