CRS Clinical Data Management & Biometrics Department provides all the services necessary to handle the data of clinical trials and of treatment observation studies at consistently topmost quality and in full compliance with all regulations concerned, e.g., CFR 21, part 11. This has been confirmed by internal GAMP4* and GAMP5* validation.
The highly qualified CRS data management team relies on more than three decades of experience in delivering continuously high-quality data. The team is at ease in working based on Sponsor’s or CRS‘ SOPs. In addition, the CRS team is also familiar with integrating sponsor-specific templates.
Capable to handle large quantities of data efficiently, the CRS team supports data expertise in every phase of early drug development such as collection, organization, validation, and quality control of clinical trial data.
The services of the CRS data management team can be contracted as part of a clinical trial or as a stand-alone service.
Data management includes the SDTM* standard in its processes, starting from the electronic Case Report Form (eCRF) until final data delivery.
With the Medrio Remote Data Capture (RDC), the CRS team has a customizable and perfomant RDC system in place to assure a high data standard and high quality. The system includes medical coding with the Medical Dictionary for Regulatory Activities (MedDRA) and the World Health Organization’s Drug Dictionary (WHO DD). The Statistical Analysis System (SAS) programmers have long standing experience with CDISC standards.
The experienced, well-trained CRS team provides statistical analysis and programming adhering to both clients’ project requirements and ICH guidelines for successful trial evaluation.
In addition, attention is paid to process optimisation while focusing on maximum results. Data analysis is performed using industry-standard SAS® software as well as WinNonlin and R Foundation for Statistical Computing (Staburo).
The software in use at the CRS Clinical Data Management & Biometrics Department is fully validated, ensuring that every phase of our customers’ trials is correctly focused for maximum results.
An important part of CRS’ range of services is to deliver trial data and report it in the form of electronic Common Technical Documents (eCTD) complying with the standards imposed by international authorities.