The data of your in-house or external clinical study is managed by an experienced team which can intervene at diferent steps:
Our CDMS ORACLE CLINICAL® 4.6 enables us to manage al your clinical data in a single system 21 CFR part 11 compliant, improving accuracy, visibility and data integrity.
Our Clinical Data Department ensures suitable management of your data, from the initiation of your project to the final report. Depending on the needs of your project, we can provide ful or à la carte services.
At Eurofins Optimed our aim is to fulfil your expectations by providing data of very high quality, meeting our deadlines and adding value through our services.
Database design & test
Electronic data capture & Paper data entry
Data Validation Plan
External data load
Coding (MedDRA, Who-Drug)
Quality control of database & discrepancy management
Final data review and reporting